FDA/CDC

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

A version of this article first appeared on Medscape.com.

A Food and Drug Administration advisory panel struggled to muster support for marketing clearance of the TriGuard 3 (Keystone Heart) device for use during transcatheter aortic valve replacement (TAVR).

The Circulatory Systems Devices Panel of the Medical Devices Advisory Committee took no vote when it met Aug. 3, but weighed evidence for a proposed indication for the device “to minimize the risk of cerebral damage by deflecting embolic debris away from the cerebral circulation” during TAVR.

“While this device may deflect some debris, the data would suggest it may also create issues,” said Keith B. Allen, MD, director of surgical research at the Mid America Heart & Lung Surgeons, Kansas City, Mo. “I am really concerned that our desire and the emotion that surrounds preventing stroke are not being supported by the data.”

TriGuard 3 received CE Mark in Europe in March 2020. It was submitted for 510(k) clearance and seeks to prove substantial equivalence to the predicate Sentinel device (Claret Medical), currently the only approved embolic protection device in the United States.

The device is designed to cover all three major aortic vessels (innominate, left carotid, and left subclavian arteries) and is delivered transfemorally through an 8F sheath, whereas the Sentinel is positioned within the branch vessels, doesn’t cover the left subclavian artery, and is introduced through the radial or brachial artery via a 6F sheath.

TriGuard 3 faced an uphill battle, however, after failing to meet the primary composite efficacy endpoint in the REFLECT phase 2 trial (P = .857), with numeric trends showing higher all-cause mortality or any stroke at 30 days (9.8% vs. 6.7%) than pooled control subjects without embolic protection.

Rates for other components of the endpoint also trended higher with the device: National Institutes of Stroke Stroke Scale score worsening 2-5 days after the procedure, cerebral ischemic lesions on MRI 2-5 days after the procedure, and total cerebral ischemic lesion volume.

The Sentinel device was approved in 2017 after it failed to meet its primary efficacy endpoint of new brain lesion volume on MRI, but death and stroke rates favored the device over control, the panel pointed out.

The sponsor provided additional analyses in the per treatment (PT) population, defined as those with complete three-vessel coverage in at least two of three procedural time points. Compared with pooled control subjects, most of the imaging endpoints favored the TriGuard 3 device, but clinical neurologic event rates continued to favor the control group.

“The data used to demonstrate efficacy are all based on the PT subpopulation of the whole population, and those have to be considered promissory data,” said John Hirshfeld, MD, emeritus professor, University of Pennsylvania, Philadelphia. “This is the group where everything went well and for us to decide that’s achievable in the general population is speculative.”
 

Safety data

The REFLECT trial did meet its primary safety endpoint, with a 30-day major adverse cardiovascular event rate of 15.9%, compared with a performance goal of 34.4% (P < .0001).

Although prespecified, panel members pushed back, saying that the performance goal was unacceptably high, with several members remarking they’d never heard of a trial adding 9% as a “fudge factor” to a 25% historic control rate to get to the 34% performance target.

Keystone health officials noted that REFLECT was not designed to demonstrate a significant difference in the rate of primary safety events, compared with control. Instead, its purpose was to demonstrate that TriGuard 3 did not increase the risk associated with a TAVR procedure.

The TriGuard 3 device was successfully placed and retrieved in 100% of patients, but complete coverage was not uniform, with 72% of 157 as-treated patients having complete three-vessel coverage post TAVR but 15% having no coverage.

Panel members also expressed concern over device interference during TAVR, which was reported in nearly 10% of all TriGuard patients.

The TriGuard 3 group had 11 major vascular complications, 2 directly related to the device, and 3 stage 3 acute kidney injuries, whereas neither complication occurred in the control group.

Throughout the 9-hour hearing, the panel wrestled with what was described as a highly select patient group and small patient numbers that made it difficult to interpret observed differences. The trial involved 157 TriGuard 3 patients (including 41 from the roll-in phase) and 119 control subjects pooled from phase 2 of the trial (n = 57) and from phase 1 using the early-stage TriGuard HDH device (n = 57).

Pieter Stella, MD, PhD, Utrecht (the Netherlands) Medical Center, also presented “real-world” evidence from 75 patients in the Netherlands using the latest iteration of the device available in Europe with updates to the crimper and additional training materials to prevent the device from torquing during delivery. No strokes were reported, one patient had a transient ischemic attack (TIA), and two patients had a dissection, which resolved without sequelae.

Ralph Brindis, MD, MPH, professor of medicine, University of California, San Francisco, countered that there were only three experienced operators from a single center and that the stroke incidence was physician reported, “not data we can really embrace.”

There was much debate over why enrollment in phase 2 of the RHYTHM trial was temporarily paused in February 2019, briefly restarted, and then prematurely stopped in April 2019.

FDA officials said the study was paused at the recommendation of the data monitoring committee (DMC) because rates of safety events were different between patients and control subjects and operational errors called into question the accuracy of the data being reviewed. Ultimately, both the DMC and FDA recommended study suspension.

During the public hearing, TAVR pioneer Alain Cribier, MD, University of Rouen’s Charles Nicolle Hospital, Mont-Saint-Aignan, France, said the TriGuard 3 is of interest because it can be used with minimal need for manipulation and complete coverage of the cerebral vessels that is achieved by diverting rather than capturing debris. “The rapid and exponential growth of TAVR procedures demands safe TAVR interventions and the use of cerebral protection devices is a step in this direction.”

Others took a dim view. “Given that the Sentinel device has not demonstrated benefit on clinical outcomes, there is significant concern about similar devices, such as the TriGuard 3, providing clinical benefit,” Rita Redberg, MD, Sanket Dhruva, MD, and Robin Ji, University of California, San Francisco, wrote in a letter submitted to the panel.

Commenting further, they added: “With the results from the REFLECT II trial demonstrating no evidence for clinical outcome benefit in TAVR patients, and numerically higher rates for stroke risk, mortality, bleeding risk, and other dangerous adverse complications among those treated, it is concerning and dangerous for patient safety that the TriGUARD 3 cerebral embolic protection device is being considered for FDA 510(k) clearance.”

The FDA panel members reported no financial relationships.

A version of this article first appeared on Medscape.com.

A Food and Drug Administration advisory panel struggled to muster support for marketing clearance of the TriGuard 3 (Keystone Heart) device for use during transcatheter aortic valve replacement (TAVR).

The Circulatory Systems Devices Panel of the Medical Devices Advisory Committee took no vote when it met Aug. 3, but weighed evidence for a proposed indication for the device “to minimize the risk of cerebral damage by deflecting embolic debris away from the cerebral circulation” during TAVR.

“While this device may deflect some debris, the data would suggest it may also create issues,” said Keith B. Allen, MD, director of surgical research at the Mid America Heart & Lung Surgeons, Kansas City, Mo. “I am really concerned that our desire and the emotion that surrounds preventing stroke are not being supported by the data.”

TriGuard 3 received CE Mark in Europe in March 2020. It was submitted for 510(k) clearance and seeks to prove substantial equivalence to the predicate Sentinel device (Claret Medical), currently the only approved embolic protection device in the United States.

The device is designed to cover all three major aortic vessels (innominate, left carotid, and left subclavian arteries) and is delivered transfemorally through an 8F sheath, whereas the Sentinel is positioned within the branch vessels, doesn’t cover the left subclavian artery, and is introduced through the radial or brachial artery via a 6F sheath.

TriGuard 3 faced an uphill battle, however, after failing to meet the primary composite efficacy endpoint in the REFLECT phase 2 trial (P = .857), with numeric trends showing higher all-cause mortality or any stroke at 30 days (9.8% vs. 6.7%) than pooled control subjects without embolic protection.

Rates for other components of the endpoint also trended higher with the device: National Institutes of Stroke Stroke Scale score worsening 2-5 days after the procedure, cerebral ischemic lesions on MRI 2-5 days after the procedure, and total cerebral ischemic lesion volume.

The Sentinel device was approved in 2017 after it failed to meet its primary efficacy endpoint of new brain lesion volume on MRI, but death and stroke rates favored the device over control, the panel pointed out.

The sponsor provided additional analyses in the per treatment (PT) population, defined as those with complete three-vessel coverage in at least two of three procedural time points. Compared with pooled control subjects, most of the imaging endpoints favored the TriGuard 3 device, but clinical neurologic event rates continued to favor the control group.

“The data used to demonstrate efficacy are all based on the PT subpopulation of the whole population, and those have to be considered promissory data,” said John Hirshfeld, MD, emeritus professor, University of Pennsylvania, Philadelphia. “This is the group where everything went well and for us to decide that’s achievable in the general population is speculative.”
 

Safety data

The REFLECT trial did meet its primary safety endpoint, with a 30-day major adverse cardiovascular event rate of 15.9%, compared with a performance goal of 34.4% (P < .0001).

Although prespecified, panel members pushed back, saying that the performance goal was unacceptably high, with several members remarking they’d never heard of a trial adding 9% as a “fudge factor” to a 25% historic control rate to get to the 34% performance target.

Keystone health officials noted that REFLECT was not designed to demonstrate a significant difference in the rate of primary safety events, compared with control. Instead, its purpose was to demonstrate that TriGuard 3 did not increase the risk associated with a TAVR procedure.

The TriGuard 3 device was successfully placed and retrieved in 100% of patients, but complete coverage was not uniform, with 72% of 157 as-treated patients having complete three-vessel coverage post TAVR but 15% having no coverage.

Panel members also expressed concern over device interference during TAVR, which was reported in nearly 10% of all TriGuard patients.

The TriGuard 3 group had 11 major vascular complications, 2 directly related to the device, and 3 stage 3 acute kidney injuries, whereas neither complication occurred in the control group.

Throughout the 9-hour hearing, the panel wrestled with what was described as a highly select patient group and small patient numbers that made it difficult to interpret observed differences. The trial involved 157 TriGuard 3 patients (including 41 from the roll-in phase) and 119 control subjects pooled from phase 2 of the trial (n = 57) and from phase 1 using the early-stage TriGuard HDH device (n = 57).

Pieter Stella, MD, PhD, Utrecht (the Netherlands) Medical Center, also presented “real-world” evidence from 75 patients in the Netherlands using the latest iteration of the device available in Europe with updates to the crimper and additional training materials to prevent the device from torquing during delivery. No strokes were reported, one patient had a transient ischemic attack (TIA), and two patients had a dissection, which resolved without sequelae.

Ralph Brindis, MD, MPH, professor of medicine, University of California, San Francisco, countered that there were only three experienced operators from a single center and that the stroke incidence was physician reported, “not data we can really embrace.”

There was much debate over why enrollment in phase 2 of the RHYTHM trial was temporarily paused in February 2019, briefly restarted, and then prematurely stopped in April 2019.

FDA officials said the study was paused at the recommendation of the data monitoring committee (DMC) because rates of safety events were different between patients and control subjects and operational errors called into question the accuracy of the data being reviewed. Ultimately, both the DMC and FDA recommended study suspension.

During the public hearing, TAVR pioneer Alain Cribier, MD, University of Rouen’s Charles Nicolle Hospital, Mont-Saint-Aignan, France, said the TriGuard 3 is of interest because it can be used with minimal need for manipulation and complete coverage of the cerebral vessels that is achieved by diverting rather than capturing debris. “The rapid and exponential growth of TAVR procedures demands safe TAVR interventions and the use of cerebral protection devices is a step in this direction.”

Others took a dim view. “Given that the Sentinel device has not demonstrated benefit on clinical outcomes, there is significant concern about similar devices, such as the TriGuard 3, providing clinical benefit,” Rita Redberg, MD, Sanket Dhruva, MD, and Robin Ji, University of California, San Francisco, wrote in a letter submitted to the panel.

Commenting further, they added: “With the results from the REFLECT II trial demonstrating no evidence for clinical outcome benefit in TAVR patients, and numerically higher rates for stroke risk, mortality, bleeding risk, and other dangerous adverse complications among those treated, it is concerning and dangerous for patient safety that the TriGUARD 3 cerebral embolic protection device is being considered for FDA 510(k) clearance.”

The FDA panel members reported no financial relationships.

A version of this article first appeared on Medscape.com.

A Food and Drug Administration advisory panel struggled to muster support for marketing clearance of the TriGuard 3 (Keystone Heart) device for use during transcatheter aortic valve replacement (TAVR).

The Circulatory Systems Devices Panel of the Medical Devices Advisory Committee took no vote when it met Aug. 3, but weighed evidence for a proposed indication for the device “to minimize the risk of cerebral damage by deflecting embolic debris away from the cerebral circulation” during TAVR.

“While this device may deflect some debris, the data would suggest it may also create issues,” said Keith B. Allen, MD, director of surgical research at the Mid America Heart & Lung Surgeons, Kansas City, Mo. “I am really concerned that our desire and the emotion that surrounds preventing stroke are not being supported by the data.”

TriGuard 3 received CE Mark in Europe in March 2020. It was submitted for 510(k) clearance and seeks to prove substantial equivalence to the predicate Sentinel device (Claret Medical), currently the only approved embolic protection device in the United States.

The device is designed to cover all three major aortic vessels (innominate, left carotid, and left subclavian arteries) and is delivered transfemorally through an 8F sheath, whereas the Sentinel is positioned within the branch vessels, doesn’t cover the left subclavian artery, and is introduced through the radial or brachial artery via a 6F sheath.

TriGuard 3 faced an uphill battle, however, after failing to meet the primary composite efficacy endpoint in the REFLECT phase 2 trial (P = .857), with numeric trends showing higher all-cause mortality or any stroke at 30 days (9.8% vs. 6.7%) than pooled control subjects without embolic protection.

Rates for other components of the endpoint also trended higher with the device: National Institutes of Stroke Stroke Scale score worsening 2-5 days after the procedure, cerebral ischemic lesions on MRI 2-5 days after the procedure, and total cerebral ischemic lesion volume.

The Sentinel device was approved in 2017 after it failed to meet its primary efficacy endpoint of new brain lesion volume on MRI, but death and stroke rates favored the device over control, the panel pointed out.

The sponsor provided additional analyses in the per treatment (PT) population, defined as those with complete three-vessel coverage in at least two of three procedural time points. Compared with pooled control subjects, most of the imaging endpoints favored the TriGuard 3 device, but clinical neurologic event rates continued to favor the control group.

“The data used to demonstrate efficacy are all based on the PT subpopulation of the whole population, and those have to be considered promissory data,” said John Hirshfeld, MD, emeritus professor, University of Pennsylvania, Philadelphia. “This is the group where everything went well and for us to decide that’s achievable in the general population is speculative.”
 

Safety data

The REFLECT trial did meet its primary safety endpoint, with a 30-day major adverse cardiovascular event rate of 15.9%, compared with a performance goal of 34.4% (P < .0001).

Although prespecified, panel members pushed back, saying that the performance goal was unacceptably high, with several members remarking they’d never heard of a trial adding 9% as a “fudge factor” to a 25% historic control rate to get to the 34% performance target.

Keystone health officials noted that REFLECT was not designed to demonstrate a significant difference in the rate of primary safety events, compared with control. Instead, its purpose was to demonstrate that TriGuard 3 did not increase the risk associated with a TAVR procedure.

The TriGuard 3 device was successfully placed and retrieved in 100% of patients, but complete coverage was not uniform, with 72% of 157 as-treated patients having complete three-vessel coverage post TAVR but 15% having no coverage.

Panel members also expressed concern over device interference during TAVR, which was reported in nearly 10% of all TriGuard patients.

The TriGuard 3 group had 11 major vascular complications, 2 directly related to the device, and 3 stage 3 acute kidney injuries, whereas neither complication occurred in the control group.

Throughout the 9-hour hearing, the panel wrestled with what was described as a highly select patient group and small patient numbers that made it difficult to interpret observed differences. The trial involved 157 TriGuard 3 patients (including 41 from the roll-in phase) and 119 control subjects pooled from phase 2 of the trial (n = 57) and from phase 1 using the early-stage TriGuard HDH device (n = 57).

Pieter Stella, MD, PhD, Utrecht (the Netherlands) Medical Center, also presented “real-world” evidence from 75 patients in the Netherlands using the latest iteration of the device available in Europe with updates to the crimper and additional training materials to prevent the device from torquing during delivery. No strokes were reported, one patient had a transient ischemic attack (TIA), and two patients had a dissection, which resolved without sequelae.

Ralph Brindis, MD, MPH, professor of medicine, University of California, San Francisco, countered that there were only three experienced operators from a single center and that the stroke incidence was physician reported, “not data we can really embrace.”

There was much debate over why enrollment in phase 2 of the RHYTHM trial was temporarily paused in February 2019, briefly restarted, and then prematurely stopped in April 2019.

FDA officials said the study was paused at the recommendation of the data monitoring committee (DMC) because rates of safety events were different between patients and control subjects and operational errors called into question the accuracy of the data being reviewed. Ultimately, both the DMC and FDA recommended study suspension.

During the public hearing, TAVR pioneer Alain Cribier, MD, University of Rouen’s Charles Nicolle Hospital, Mont-Saint-Aignan, France, said the TriGuard 3 is of interest because it can be used with minimal need for manipulation and complete coverage of the cerebral vessels that is achieved by diverting rather than capturing debris. “The rapid and exponential growth of TAVR procedures demands safe TAVR interventions and the use of cerebral protection devices is a step in this direction.”

Others took a dim view. “Given that the Sentinel device has not demonstrated benefit on clinical outcomes, there is significant concern about similar devices, such as the TriGuard 3, providing clinical benefit,” Rita Redberg, MD, Sanket Dhruva, MD, and Robin Ji, University of California, San Francisco, wrote in a letter submitted to the panel.

Commenting further, they added: “With the results from the REFLECT II trial demonstrating no evidence for clinical outcome benefit in TAVR patients, and numerically higher rates for stroke risk, mortality, bleeding risk, and other dangerous adverse complications among those treated, it is concerning and dangerous for patient safety that the TriGUARD 3 cerebral embolic protection device is being considered for FDA 510(k) clearance.”

The FDA panel members reported no financial relationships.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the neoadjuvant use of pembrolizumab (Keytruda) in combination with chemotherapy for patients with high-risk early-stage triple-negative breast cancer (TNBC) and as single-agent adjuvant treatment to be continued after surgery.

This approval is based on findings from the randomized, phase 3 KEYNOTE-522 trial, which showed significantly prolonged event-free survival with the pembrolizumab regimen versus neoadjuvant chemotherapy alone for previously untreated stage II-III TNBC.

This is the 30th indication for pembrolizumab in the United States.

The immunotherapy received accelerated approval in November 2020 for adjuvant use in locally recurrent unresectable or metastatic TNBC for patients whose tumors express programmed death–ligand-1, as determined by an FDA-approved test. That accelerated approval was based on results from the phase 3 KEYNOTE-355 trial. The approval has now been converted to a full approval on the basis of confirmatory data from the KEYNOTE-522, notes a statement from the manufacturer, Merck.

“Triple-negative is a difficult-to-treat type of breast cancer that unfortunately is more common in the U.S. in younger women and in Black women,” commented Vicki Goodman, MD, vice president of clinical research, Merck Research Laboratories. “We are proud to offer a new treatment option for patients faced with this challenging cancer. This neoadjuvant and adjuvant combination with pembrolizumab is the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a meaningful milestone for the breast cancer community.”

In KEYNOTE-522, participants were randomly assigned to receive either placebo or pembrolizumab plus chemotherapy with carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide before surgery, as well as placebo or pembrolizumab as single-agent therapy after surgery.

The results from this trial, first reported in 2019 at the annual meeting of the European Society of Medical Oncology, showed that, for patients in the pembrolizumab arm of the trial, the pathological complete response rate was nearly 65% versus 51% among the patients who received placebo. The benefit was seen both in those whose tumors were positive and those whose tumors were negative for PD-L1 expression.

Among patients in the pembrolizumab arm, there was a 37% reduction in the risk for disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause (hazard ratio, 0.63).

Pembrolizumab can be associated with immune-mediated adverse reactions that may be severe or fatal, Merck noted.

These events “can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment,” Merck warned. The company states: “Early identification and management of immune-mediated adverse reactions are essential.”

Treatment may need to be withheld or permanently discontinued, and corticosteroids may be needed, depending on the severity of the adverse reaction, according to the statement.

Infusion-related reactions can also occur. Because of its mechanism of action, pembrolizumab can cause fetal harm when administered to women during pregnancy.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the neoadjuvant use of pembrolizumab (Keytruda) in combination with chemotherapy for patients with high-risk early-stage triple-negative breast cancer (TNBC) and as single-agent adjuvant treatment to be continued after surgery.

This approval is based on findings from the randomized, phase 3 KEYNOTE-522 trial, which showed significantly prolonged event-free survival with the pembrolizumab regimen versus neoadjuvant chemotherapy alone for previously untreated stage II-III TNBC.

This is the 30th indication for pembrolizumab in the United States.

The immunotherapy received accelerated approval in November 2020 for adjuvant use in locally recurrent unresectable or metastatic TNBC for patients whose tumors express programmed death–ligand-1, as determined by an FDA-approved test. That accelerated approval was based on results from the phase 3 KEYNOTE-355 trial. The approval has now been converted to a full approval on the basis of confirmatory data from the KEYNOTE-522, notes a statement from the manufacturer, Merck.

“Triple-negative is a difficult-to-treat type of breast cancer that unfortunately is more common in the U.S. in younger women and in Black women,” commented Vicki Goodman, MD, vice president of clinical research, Merck Research Laboratories. “We are proud to offer a new treatment option for patients faced with this challenging cancer. This neoadjuvant and adjuvant combination with pembrolizumab is the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a meaningful milestone for the breast cancer community.”

In KEYNOTE-522, participants were randomly assigned to receive either placebo or pembrolizumab plus chemotherapy with carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide before surgery, as well as placebo or pembrolizumab as single-agent therapy after surgery.

The results from this trial, first reported in 2019 at the annual meeting of the European Society of Medical Oncology, showed that, for patients in the pembrolizumab arm of the trial, the pathological complete response rate was nearly 65% versus 51% among the patients who received placebo. The benefit was seen both in those whose tumors were positive and those whose tumors were negative for PD-L1 expression.

Among patients in the pembrolizumab arm, there was a 37% reduction in the risk for disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause (hazard ratio, 0.63).

Pembrolizumab can be associated with immune-mediated adverse reactions that may be severe or fatal, Merck noted.

These events “can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment,” Merck warned. The company states: “Early identification and management of immune-mediated adverse reactions are essential.”

Treatment may need to be withheld or permanently discontinued, and corticosteroids may be needed, depending on the severity of the adverse reaction, according to the statement.

Infusion-related reactions can also occur. Because of its mechanism of action, pembrolizumab can cause fetal harm when administered to women during pregnancy.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the neoadjuvant use of pembrolizumab (Keytruda) in combination with chemotherapy for patients with high-risk early-stage triple-negative breast cancer (TNBC) and as single-agent adjuvant treatment to be continued after surgery.

This approval is based on findings from the randomized, phase 3 KEYNOTE-522 trial, which showed significantly prolonged event-free survival with the pembrolizumab regimen versus neoadjuvant chemotherapy alone for previously untreated stage II-III TNBC.

This is the 30th indication for pembrolizumab in the United States.

The immunotherapy received accelerated approval in November 2020 for adjuvant use in locally recurrent unresectable or metastatic TNBC for patients whose tumors express programmed death–ligand-1, as determined by an FDA-approved test. That accelerated approval was based on results from the phase 3 KEYNOTE-355 trial. The approval has now been converted to a full approval on the basis of confirmatory data from the KEYNOTE-522, notes a statement from the manufacturer, Merck.

“Triple-negative is a difficult-to-treat type of breast cancer that unfortunately is more common in the U.S. in younger women and in Black women,” commented Vicki Goodman, MD, vice president of clinical research, Merck Research Laboratories. “We are proud to offer a new treatment option for patients faced with this challenging cancer. This neoadjuvant and adjuvant combination with pembrolizumab is the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a meaningful milestone for the breast cancer community.”

In KEYNOTE-522, participants were randomly assigned to receive either placebo or pembrolizumab plus chemotherapy with carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide before surgery, as well as placebo or pembrolizumab as single-agent therapy after surgery.

The results from this trial, first reported in 2019 at the annual meeting of the European Society of Medical Oncology, showed that, for patients in the pembrolizumab arm of the trial, the pathological complete response rate was nearly 65% versus 51% among the patients who received placebo. The benefit was seen both in those whose tumors were positive and those whose tumors were negative for PD-L1 expression.

Among patients in the pembrolizumab arm, there was a 37% reduction in the risk for disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause (hazard ratio, 0.63).

Pembrolizumab can be associated with immune-mediated adverse reactions that may be severe or fatal, Merck noted.

These events “can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment,” Merck warned. The company states: “Early identification and management of immune-mediated adverse reactions are essential.”

Treatment may need to be withheld or permanently discontinued, and corticosteroids may be needed, depending on the severity of the adverse reaction, according to the statement.

Infusion-related reactions can also occur. Because of its mechanism of action, pembrolizumab can cause fetal harm when administered to women during pregnancy.

A version of this article first appeared on Medscape.com.

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus … [becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Dr. Walensky told reporters on July 27. 

A new, more elusive variant could be “just a few mutations away,” she said.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School in Newark, told this news organization.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta – that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Dr. Ray, vice-chair of medicine for data integrity and analytics and professor in the division of infectious diseases at Johns Hopkins School of Medicine in Baltimore.

“The problem is if the virus changes in such a way that the spike protein – which the antibodies from the vaccine are directed against – are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Dr. Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”
 

Technology to the rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Dr. Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”
 

Nothing appears certain

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Dr. Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Dr. Nelson and Dr. Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Dr. Ray said.
 

Mutations not the only concern

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Dr. Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Dr. Ray said.
 

Protected, for now

Dr. Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Dr. Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the first interchangeable insulin, Semglee (Mylan Pharmaceuticals), which can be substituted for glargine (Lantus, Sanofi) at the pharmacy without the need for a separate prescription.

The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.

It is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.

Originally approved in June 2020 as a biosimilar to glargine, Semglee is now an “interchangeable biosimilar,” meaning that it has no clinically meaningful difference from the reference product and also may be substituted for that product – in this case, glargine (Lantus) – without prescriber intervention, just as generic drugs typically are, subject to state pharmacy laws.

For approval as an interchangeable biosimilar, manufacturers are required to provide additional data reflecting how the interchangeable biosimilar may be used in the marketplace with patients.

“Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” the FDA said in a statement.

Semglee comes in 10-mL and 3-mL prefilled pens, and is administered subcutaneously once daily, with individualized doses. The most common side effects are hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions.

The FDA released new materials for health care providers regarding biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the first interchangeable insulin, Semglee (Mylan Pharmaceuticals), which can be substituted for glargine (Lantus, Sanofi) at the pharmacy without the need for a separate prescription.

The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.

It is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.

Originally approved in June 2020 as a biosimilar to glargine, Semglee is now an “interchangeable biosimilar,” meaning that it has no clinically meaningful difference from the reference product and also may be substituted for that product – in this case, glargine (Lantus) – without prescriber intervention, just as generic drugs typically are, subject to state pharmacy laws.

For approval as an interchangeable biosimilar, manufacturers are required to provide additional data reflecting how the interchangeable biosimilar may be used in the marketplace with patients.

“Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” the FDA said in a statement.

Semglee comes in 10-mL and 3-mL prefilled pens, and is administered subcutaneously once daily, with individualized doses. The most common side effects are hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions.

The FDA released new materials for health care providers regarding biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the first interchangeable insulin, Semglee (Mylan Pharmaceuticals), which can be substituted for glargine (Lantus, Sanofi) at the pharmacy without the need for a separate prescription.

The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.

It is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.

Originally approved in June 2020 as a biosimilar to glargine, Semglee is now an “interchangeable biosimilar,” meaning that it has no clinically meaningful difference from the reference product and also may be substituted for that product – in this case, glargine (Lantus) – without prescriber intervention, just as generic drugs typically are, subject to state pharmacy laws.

For approval as an interchangeable biosimilar, manufacturers are required to provide additional data reflecting how the interchangeable biosimilar may be used in the marketplace with patients.

“Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” the FDA said in a statement.

Semglee comes in 10-mL and 3-mL prefilled pens, and is administered subcutaneously once daily, with individualized doses. The most common side effects are hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions.

The FDA released new materials for health care providers regarding biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has issued a safety alert regarding an increased risk of death associated with Pepaxto (melphalan flufenamide) used in patients with multiple myeloma participating in the ongoing OCEAN clinical trial.

The drug was granted accelerated approval in February 2021 for use in combination with dexamethasone in the treatment of adults with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulator, and one CD38-directed monoclonal antibody.

As a condition of the accelerated approval, the manufacturer, Oncopeptides, was required to conduct a confirmatory clinical trial and launched the OCEAN trial.

Enrollment in OCEAN as well as other ongoing trials of the drug have now been halted, according to the FDA alert.

The warning comes in the wake of OCEAN trial findings showing worse survival among patients in the experimental group, who were receiving melphalan plus low-dose dexamethasone, compared with patients in the control group, who were receiving pomalidomide plus low-dose dexamethasone (hazard ratio for overall survival, 1.104). Median overall survival in the treatment and control groups was 19.7 and 25.0 months, respectively.

Health care professionals should “review patients’ progress on Pepaxto and discuss the risks of continued administration with each patient in the context of other treatments,” and patients currently receiving the drug should discuss the risks and benefits with their health care professional, the FDA advises. “Patients receiving clinical benefit from Pepaxto may continue treatment in the OCEAN trial provided they are informed of the risks and sign a revised written informed consent.”

The FDA also hinted at “a future public meeting to discuss the safety findings and explore the continued marketing of Pepaxto,” which has a price tag of $19,000 per treatment course.
 

Accelerated approval data

Melphalan flufenamide was initially evaluated in combination with low-dose dexamethasone in the multicenter, single-arm HORIZON trial of adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulator, and one CD38-directed monoclonal antibody.

Patients received melphalan flufenamide at a dose of 40 mg intravenously on day 1 along with oral dexamethasone at a dose of 40 mg (or 20 mg for those over age 75 years) on days 1, 8, 15, and 22 of each 28-day cycle until disease progression or unacceptable toxicity.

The most common adverse reactions, occurring in at least 20% of patients, were fatigue, nausea, diarrhea, pyrexia, and respiratory tract infection. The most common laboratory abnormalities, occurring in at least 50% of patients, were decreased leukocytes, platelets, lymphocytes, neutrophils, and hemoglobin, and increased creatinine.

Accelerated approval was granted after the HORIZON trial showed an overall response rate of 23.7% and median duration of response of 4.2 months. The application by Oncopeptides received priority review and orphan drug status.
 

Confirmatory trial data

The confirmatory OCEAN trial compared melphalan flufenamide plus low-dose dexamethasone to pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma following 2-4 lines of therapy and in patients who were resistant to lenalidomide in the last line of therapy.

The FDA conducted an efficacy and safety evaluation of the OCEAN trial using a data cutoff date of February 3, 2021. At a median follow-up of 19.1 months, 117 of 246 patients (48%) in the melphalan flufenamide group had died, compared with 108 of 249 patients (43%) in the pomalidomide control group.

“Patient safety is paramount to Oncopeptides,” the company said in a press statement, which also notes that “dialogue with the FDA” is ongoing and that updated information will be provided as it becomes available.

The company plans to submit complete data from the OCEAN study to the International Myeloma Workshop meeting in Vienna being held September 8-11, 2021.

Health care professionals and patients should report adverse events or quality issues experienced with melphalan flufenamide or any other medication to the FDA MedWatch Adverse Event Reporting program, either online or by downloading and completing a reporting form and submitting via fax at 1-800-FDA-0178.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has issued a safety alert regarding an increased risk of death associated with Pepaxto (melphalan flufenamide) used in patients with multiple myeloma participating in the ongoing OCEAN clinical trial.

The drug was granted accelerated approval in February 2021 for use in combination with dexamethasone in the treatment of adults with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulator, and one CD38-directed monoclonal antibody.

As a condition of the accelerated approval, the manufacturer, Oncopeptides, was required to conduct a confirmatory clinical trial and launched the OCEAN trial.

Enrollment in OCEAN as well as other ongoing trials of the drug have now been halted, according to the FDA alert.

The warning comes in the wake of OCEAN trial findings showing worse survival among patients in the experimental group, who were receiving melphalan plus low-dose dexamethasone, compared with patients in the control group, who were receiving pomalidomide plus low-dose dexamethasone (hazard ratio for overall survival, 1.104). Median overall survival in the treatment and control groups was 19.7 and 25.0 months, respectively.

Health care professionals should “review patients’ progress on Pepaxto and discuss the risks of continued administration with each patient in the context of other treatments,” and patients currently receiving the drug should discuss the risks and benefits with their health care professional, the FDA advises. “Patients receiving clinical benefit from Pepaxto may continue treatment in the OCEAN trial provided they are informed of the risks and sign a revised written informed consent.”

The FDA also hinted at “a future public meeting to discuss the safety findings and explore the continued marketing of Pepaxto,” which has a price tag of $19,000 per treatment course.
 

Accelerated approval data

Melphalan flufenamide was initially evaluated in combination with low-dose dexamethasone in the multicenter, single-arm HORIZON trial of adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulator, and one CD38-directed monoclonal antibody.

Patients received melphalan flufenamide at a dose of 40 mg intravenously on day 1 along with oral dexamethasone at a dose of 40 mg (or 20 mg for those over age 75 years) on days 1, 8, 15, and 22 of each 28-day cycle until disease progression or unacceptable toxicity.

The most common adverse reactions, occurring in at least 20% of patients, were fatigue, nausea, diarrhea, pyrexia, and respiratory tract infection. The most common laboratory abnormalities, occurring in at least 50% of patients, were decreased leukocytes, platelets, lymphocytes, neutrophils, and hemoglobin, and increased creatinine.

Accelerated approval was granted after the HORIZON trial showed an overall response rate of 23.7% and median duration of response of 4.2 months. The application by Oncopeptides received priority review and orphan drug status.
 

Confirmatory trial data

The confirmatory OCEAN trial compared melphalan flufenamide plus low-dose dexamethasone to pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma following 2-4 lines of therapy and in patients who were resistant to lenalidomide in the last line of therapy.

The FDA conducted an efficacy and safety evaluation of the OCEAN trial using a data cutoff date of February 3, 2021. At a median follow-up of 19.1 months, 117 of 246 patients (48%) in the melphalan flufenamide group had died, compared with 108 of 249 patients (43%) in the pomalidomide control group.

“Patient safety is paramount to Oncopeptides,” the company said in a press statement, which also notes that “dialogue with the FDA” is ongoing and that updated information will be provided as it becomes available.

The company plans to submit complete data from the OCEAN study to the International Myeloma Workshop meeting in Vienna being held September 8-11, 2021.

Health care professionals and patients should report adverse events or quality issues experienced with melphalan flufenamide or any other medication to the FDA MedWatch Adverse Event Reporting program, either online or by downloading and completing a reporting form and submitting via fax at 1-800-FDA-0178.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has issued a safety alert regarding an increased risk of death associated with Pepaxto (melphalan flufenamide) used in patients with multiple myeloma participating in the ongoing OCEAN clinical trial.

The drug was granted accelerated approval in February 2021 for use in combination with dexamethasone in the treatment of adults with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulator, and one CD38-directed monoclonal antibody.

As a condition of the accelerated approval, the manufacturer, Oncopeptides, was required to conduct a confirmatory clinical trial and launched the OCEAN trial.

Enrollment in OCEAN as well as other ongoing trials of the drug have now been halted, according to the FDA alert.

The warning comes in the wake of OCEAN trial findings showing worse survival among patients in the experimental group, who were receiving melphalan plus low-dose dexamethasone, compared with patients in the control group, who were receiving pomalidomide plus low-dose dexamethasone (hazard ratio for overall survival, 1.104). Median overall survival in the treatment and control groups was 19.7 and 25.0 months, respectively.

Health care professionals should “review patients’ progress on Pepaxto and discuss the risks of continued administration with each patient in the context of other treatments,” and patients currently receiving the drug should discuss the risks and benefits with their health care professional, the FDA advises. “Patients receiving clinical benefit from Pepaxto may continue treatment in the OCEAN trial provided they are informed of the risks and sign a revised written informed consent.”

The FDA also hinted at “a future public meeting to discuss the safety findings and explore the continued marketing of Pepaxto,” which has a price tag of $19,000 per treatment course.
 

Accelerated approval data

Melphalan flufenamide was initially evaluated in combination with low-dose dexamethasone in the multicenter, single-arm HORIZON trial of adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulator, and one CD38-directed monoclonal antibody.

Patients received melphalan flufenamide at a dose of 40 mg intravenously on day 1 along with oral dexamethasone at a dose of 40 mg (or 20 mg for those over age 75 years) on days 1, 8, 15, and 22 of each 28-day cycle until disease progression or unacceptable toxicity.

The most common adverse reactions, occurring in at least 20% of patients, were fatigue, nausea, diarrhea, pyrexia, and respiratory tract infection. The most common laboratory abnormalities, occurring in at least 50% of patients, were decreased leukocytes, platelets, lymphocytes, neutrophils, and hemoglobin, and increased creatinine.

Accelerated approval was granted after the HORIZON trial showed an overall response rate of 23.7% and median duration of response of 4.2 months. The application by Oncopeptides received priority review and orphan drug status.
 

Confirmatory trial data

The confirmatory OCEAN trial compared melphalan flufenamide plus low-dose dexamethasone to pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma following 2-4 lines of therapy and in patients who were resistant to lenalidomide in the last line of therapy.

The FDA conducted an efficacy and safety evaluation of the OCEAN trial using a data cutoff date of February 3, 2021. At a median follow-up of 19.1 months, 117 of 246 patients (48%) in the melphalan flufenamide group had died, compared with 108 of 249 patients (43%) in the pomalidomide control group.

“Patient safety is paramount to Oncopeptides,” the company said in a press statement, which also notes that “dialogue with the FDA” is ongoing and that updated information will be provided as it becomes available.

The company plans to submit complete data from the OCEAN study to the International Myeloma Workshop meeting in Vienna being held September 8-11, 2021.

Health care professionals and patients should report adverse events or quality issues experienced with melphalan flufenamide or any other medication to the FDA MedWatch Adverse Event Reporting program, either online or by downloading and completing a reporting form and submitting via fax at 1-800-FDA-0178.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention (CDC) once again is recommending that some Americans wear masks indoors. The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.

The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.

Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.

“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.

New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.

“This new science is worrisome,” she said.

Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”

As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
 

Masks in schools

The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.

The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.

The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
 

“A prudent move”

“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.

Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”

What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
 

“I know it’s difficult”

Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”

“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.

She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.

“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
 

Breakthrough transmissions

“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.

“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”

It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
 

IDSA and AMA support mask change

The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.

“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”

“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.

The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.

“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.

“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”

“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”

“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention (CDC) once again is recommending that some Americans wear masks indoors. The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.

The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.

Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.

“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.

New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.

“This new science is worrisome,” she said.

Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”

As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
 

Masks in schools

The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.

The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.

The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
 

“A prudent move”

“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.

Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”

What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
 

“I know it’s difficult”

Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”

“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.

She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.

“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
 

Breakthrough transmissions

“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.

“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”

It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
 

IDSA and AMA support mask change

The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.

“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”

“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.

The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.

“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.

“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”

“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”

“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention (CDC) once again is recommending that some Americans wear masks indoors. The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.

The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.

Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.

“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.

New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.

“This new science is worrisome,” she said.

Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”

As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
 

Masks in schools

The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.

The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.

The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
 

“A prudent move”

“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.

Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”

What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
 

“I know it’s difficult”

Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”

“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.

She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.

“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
 

Breakthrough transmissions

“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.

“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”

It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
 

IDSA and AMA support mask change

The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.

“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”

“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.

The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.

“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.

“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”

“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”

“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved exenatide extended release (Bydureon/Bydureon BCise, AstraZeneca) for use in children with type 2 diabetes down to 10 years of age, the agency announced July 22.

Olivier Le Moal/Getty Images

Previously approved in adults, the injectable is now the second glucagonlike peptide-1 receptor agonist approved for use in pediatric type 2 diabetes, after liraglutide (Victoza, Novo Nordisk) in 2019, and the first with once-weekly administration.

The two extended-release Bydureon products – which differ in delivery device and mixing procedure – are now indicated for use in addition to diet and exercise to improve glycemic control in pediatric patients 10 years of age or older with type 2 diabetes.

Exenatide extended release is not recommended as first-line treatment following diet and exercise.

The approval was based on a 24-week, double-blind, placebo-controlled study in 82 children with type 2 diabetes aged 10 and older. They were randomized to 2 mg once-weekly exenatide extended release or placebo. At week 24, hemoglobin A1c in those randomized to the drug had dropped by 0.25 percentage points, compared with a 0.45 percentage point increase in the placebo group.

Side effects were similar to those seen in adults, including injection site reactions, headaches, and gastrointestinal discomfort.

Currently, metformin is the only oral medication approved for treating pediatric type 2 diabetes, while the injectables also include insulin in addition to the two GLP-1 receptor agonists. During a symposium held in June 2021 at the annual scientific sessions of the American Diabetes Association, speakers expressed alarm about the rise in youth developing type 2 diabetes, noting that the condition typically progresses more rapidly and is less likely to respond well to metformin, compared with adults.

But, the panelists were also optimistic about extended-release exenatide as well as several other therapies for pediatric patients with type 2 diabetes in ongoing phase 3 trials, including the sodium-glucose cotransporter 2 inhibitors dapagliflozin and empagliflozin, and the dipeptidyl peptidase–4 inhibitors alogliptin and linagliptin. Results are expected in the next 1-2 years.

The Food and Drug Administration has approved exenatide extended release (Bydureon/Bydureon BCise, AstraZeneca) for use in children with type 2 diabetes down to 10 years of age, the agency announced July 22.

Olivier Le Moal/Getty Images

Previously approved in adults, the injectable is now the second glucagonlike peptide-1 receptor agonist approved for use in pediatric type 2 diabetes, after liraglutide (Victoza, Novo Nordisk) in 2019, and the first with once-weekly administration.

The two extended-release Bydureon products – which differ in delivery device and mixing procedure – are now indicated for use in addition to diet and exercise to improve glycemic control in pediatric patients 10 years of age or older with type 2 diabetes.

Exenatide extended release is not recommended as first-line treatment following diet and exercise.

The approval was based on a 24-week, double-blind, placebo-controlled study in 82 children with type 2 diabetes aged 10 and older. They were randomized to 2 mg once-weekly exenatide extended release or placebo. At week 24, hemoglobin A1c in those randomized to the drug had dropped by 0.25 percentage points, compared with a 0.45 percentage point increase in the placebo group.

Side effects were similar to those seen in adults, including injection site reactions, headaches, and gastrointestinal discomfort.

Currently, metformin is the only oral medication approved for treating pediatric type 2 diabetes, while the injectables also include insulin in addition to the two GLP-1 receptor agonists. During a symposium held in June 2021 at the annual scientific sessions of the American Diabetes Association, speakers expressed alarm about the rise in youth developing type 2 diabetes, noting that the condition typically progresses more rapidly and is less likely to respond well to metformin, compared with adults.

But, the panelists were also optimistic about extended-release exenatide as well as several other therapies for pediatric patients with type 2 diabetes in ongoing phase 3 trials, including the sodium-glucose cotransporter 2 inhibitors dapagliflozin and empagliflozin, and the dipeptidyl peptidase–4 inhibitors alogliptin and linagliptin. Results are expected in the next 1-2 years.

The Food and Drug Administration has approved exenatide extended release (Bydureon/Bydureon BCise, AstraZeneca) for use in children with type 2 diabetes down to 10 years of age, the agency announced July 22.

Olivier Le Moal/Getty Images

Previously approved in adults, the injectable is now the second glucagonlike peptide-1 receptor agonist approved for use in pediatric type 2 diabetes, after liraglutide (Victoza, Novo Nordisk) in 2019, and the first with once-weekly administration.

The two extended-release Bydureon products – which differ in delivery device and mixing procedure – are now indicated for use in addition to diet and exercise to improve glycemic control in pediatric patients 10 years of age or older with type 2 diabetes.

Exenatide extended release is not recommended as first-line treatment following diet and exercise.

The approval was based on a 24-week, double-blind, placebo-controlled study in 82 children with type 2 diabetes aged 10 and older. They were randomized to 2 mg once-weekly exenatide extended release or placebo. At week 24, hemoglobin A1c in those randomized to the drug had dropped by 0.25 percentage points, compared with a 0.45 percentage point increase in the placebo group.

Side effects were similar to those seen in adults, including injection site reactions, headaches, and gastrointestinal discomfort.

Currently, metformin is the only oral medication approved for treating pediatric type 2 diabetes, while the injectables also include insulin in addition to the two GLP-1 receptor agonists. During a symposium held in June 2021 at the annual scientific sessions of the American Diabetes Association, speakers expressed alarm about the rise in youth developing type 2 diabetes, noting that the condition typically progresses more rapidly and is less likely to respond well to metformin, compared with adults.

But, the panelists were also optimistic about extended-release exenatide as well as several other therapies for pediatric patients with type 2 diabetes in ongoing phase 3 trials, including the sodium-glucose cotransporter 2 inhibitors dapagliflozin and empagliflozin, and the dipeptidyl peptidase–4 inhibitors alogliptin and linagliptin. Results are expected in the next 1-2 years.

On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

• Updated treatment recommendations for gonorrhea, chlamydia, , and 
• Two-step testing for diagnosing genital  virus
• Expanded risk factors for  testing in pregnant women
• Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
• A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

A version of this article first appeared on Medscape.com.

On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

• Updated treatment recommendations for gonorrhea, chlamydia, , and 
• Two-step testing for diagnosing genital  virus
• Expanded risk factors for  testing in pregnant women
• Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
• A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

A version of this article first appeared on Medscape.com.

On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

• Updated treatment recommendations for gonorrhea, chlamydia, , and 
• Two-step testing for diagnosing genital  virus
• Expanded risk factors for  testing in pregnant women
• Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
• A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

A version of this article first appeared on Medscape.com.