Mahalingam et al in the Journal of Maternal-Fetal & Neonatal Medicine reported the risk of preterm birth among women with uterine fibroids who underwent myomectomy versus those who did not prior to pregnancy. In this retrospective cohort study, the team evaluated 290 women with a viable intrauterine pregnancy and history of uterine fibroids and compared two groups: 70 with history of a prior myomectomy and 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation. The team found that women who underwent prior myomectomy versus those who did not were more likely to deliver preterm < 37 weeks gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks gestation; P = .02). Patients with history of myomectomy had a higher C-section rate (88% vs 53%, P < 0.001). However, when the authors controlled for late preterm pre-labor C-sections recommended by physicians in the myomectomy cohort (n=5), the difference in preterm birth was not significant between the groups.

Lee et al reported that MRI can potentially predict the benefit of GnRH-agonist treatment prior to for large fibroids. In this retrospective analysis published in Acta Radiologica, 30 patients with large uterine fibroids received GnRH agonist prior to uterine artery embolization (UAE) with MRI evaluation before and after treatment. Indications for GnRH-agonist treatment (monthly 3.75 mg leuprolide acetate injections) included intramural or subserosal fibroids > 10 cm in diameter or pedunculated submucosal fibroids > 8 cm, as well as contrast enhancement observed on T1-weighted (T1W) images. Mean maximum fibroid diameter was 11.1 + 1.9 cm and mean number of GnRH-agonist injections received was 2.8. Signal intensity (SI) of the predominant fibroid on T2-weighted (T2W) images was referenced to the SI of the rectus abdominus muscle (F/R). For predicting a volume reduction rate of the large fibroid of >50%, the optimal cut-off value of F/R was 2.58 (sensitivity 80%, specificity 80%). Likewise, large fibroids with a volume rate reduction of <30% had an optimal cut-off volume of 1.69 (sensitivity 100%, specificity 70%). From a clinical perspective, both surgeons and radiologists could use SI of the predominant fibroid on T2W to predict response to GnRH agonist pretreatment.

Mahalingam et al in the Journal of Maternal-Fetal & Neonatal Medicine reported the risk of preterm birth among women with uterine fibroids who underwent myomectomy versus those who did not prior to pregnancy. In this retrospective cohort study, the team evaluated 290 women with a viable intrauterine pregnancy and history of uterine fibroids and compared two groups: 70 with history of a prior myomectomy and 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation. The team found that women who underwent prior myomectomy versus those who did not were more likely to deliver preterm < 37 weeks gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks gestation; P = .02). Patients with history of myomectomy had a higher C-section rate (88% vs 53%, P < 0.001). However, when the authors controlled for late preterm pre-labor C-sections recommended by physicians in the myomectomy cohort (n=5), the difference in preterm birth was not significant between the groups.

Lee et al reported that MRI can potentially predict the benefit of GnRH-agonist treatment prior to for large fibroids. In this retrospective analysis published in Acta Radiologica, 30 patients with large uterine fibroids received GnRH agonist prior to uterine artery embolization (UAE) with MRI evaluation before and after treatment. Indications for GnRH-agonist treatment (monthly 3.75 mg leuprolide acetate injections) included intramural or subserosal fibroids > 10 cm in diameter or pedunculated submucosal fibroids > 8 cm, as well as contrast enhancement observed on T1-weighted (T1W) images. Mean maximum fibroid diameter was 11.1 + 1.9 cm and mean number of GnRH-agonist injections received was 2.8. Signal intensity (SI) of the predominant fibroid on T2-weighted (T2W) images was referenced to the SI of the rectus abdominus muscle (F/R). For predicting a volume reduction rate of the large fibroid of >50%, the optimal cut-off value of F/R was 2.58 (sensitivity 80%, specificity 80%). Likewise, large fibroids with a volume rate reduction of <30% had an optimal cut-off volume of 1.69 (sensitivity 100%, specificity 70%). From a clinical perspective, both surgeons and radiologists could use SI of the predominant fibroid on T2W to predict response to GnRH agonist pretreatment.

Mahalingam et al in the Journal of Maternal-Fetal & Neonatal Medicine reported the risk of preterm birth among women with uterine fibroids who underwent myomectomy versus those who did not prior to pregnancy. In this retrospective cohort study, the team evaluated 290 women with a viable intrauterine pregnancy and history of uterine fibroids and compared two groups: 70 with history of a prior myomectomy and 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation. The team found that women who underwent prior myomectomy versus those who did not were more likely to deliver preterm < 37 weeks gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks gestation; P = .02). Patients with history of myomectomy had a higher C-section rate (88% vs 53%, P < 0.001). However, when the authors controlled for late preterm pre-labor C-sections recommended by physicians in the myomectomy cohort (n=5), the difference in preterm birth was not significant between the groups.

Lee et al reported that MRI can potentially predict the benefit of GnRH-agonist treatment prior to for large fibroids. In this retrospective analysis published in Acta Radiologica, 30 patients with large uterine fibroids received GnRH agonist prior to uterine artery embolization (UAE) with MRI evaluation before and after treatment. Indications for GnRH-agonist treatment (monthly 3.75 mg leuprolide acetate injections) included intramural or subserosal fibroids > 10 cm in diameter or pedunculated submucosal fibroids > 8 cm, as well as contrast enhancement observed on T1-weighted (T1W) images. Mean maximum fibroid diameter was 11.1 + 1.9 cm and mean number of GnRH-agonist injections received was 2.8. Signal intensity (SI) of the predominant fibroid on T2-weighted (T2W) images was referenced to the SI of the rectus abdominus muscle (F/R). For predicting a volume reduction rate of the large fibroid of >50%, the optimal cut-off value of F/R was 2.58 (sensitivity 80%, specificity 80%). Likewise, large fibroids with a volume rate reduction of <30% had an optimal cut-off volume of 1.69 (sensitivity 100%, specificity 70%). From a clinical perspective, both surgeons and radiologists could use SI of the predominant fibroid on T2W to predict response to GnRH agonist pretreatment.

Biologic therapy is generally reserved for patients with more moderate-to-severe psoriasis, often defined as BSA ≥10% or PASI of ≥10. Notably, these criteria are all clinician-performed. The Dermatology Life Quality Index (DLQI) measures the impact of the disease on the patient with a score of 0-5, 6-10, and 11-30 indicating mild, moderate, and severe disease, respectively. In a cross-sectional, observational study, 72.4% of psoriasis patients who qualified for systemic therapy initiation based on PASI and/or BSA had a DLQI of less than 10. Conversely, 10.4% of patients with a DLQI score higher than 10 did not qualify for systemic therapy based on PASI and/or BSA. This study highlights the complementary value of considering both clinician and patient determinants of disease severity when choosing a psoriasis therapy (Barbieri JS et al.)

With so many therapeutic options, it is increasingly common for patients to switch from one biologic to another. Many factors that go into the decision to switch therapies. A retrospective study of 115 adult patients with psoriasis found that the primary factor driving switching was lack of sufficient efficacy in treating skin disease. Having concomitant psoriatic arthritis increased the likelihood of switching by 2.69-fold (Akdogan N et al.). These findings suggest that shared decision making with dermatology, rheumatology, and the patient may help in choosing a treatment plan that best addresses both skin and joints.

One consideration when counseling patients about their likelihood of response to a second or third biologic is that in several clinical trials, biologic-naïve patients tend to have higher PASI responses to biologics than do heavier and biologic-experienced patients. A recent retrospective study found that receiving one or more biologic receiving was associated with a lower likelihood of achieving a PASI75 response to guselkumab (Hung YT et al.). However, in a real-life multicenter study including 57 adult patients with moderate-to-severe psoriasis receiving risankizumab, more biologic-experienced patients reached PASI 100 at weeks 36 and 52 (71.8% and 69.2%, respectively) compared with biologic-naïve patients (50.0% and 37.5%, respectively) (Gerdes S et al.). While both studies were small and no firm conclusions or comparisons can be drawn, real-world data from large multicenter studies that evaluate multiple therapies may guide us in choosing the best therapy for challenging patients who are often underrepresented in clinical trials. Understanding how switching within vs. between classes (TNF, IL-17, and IL-23 inhibitors) impacts efficacy will also help in making choices about biologic switches.

Biologic therapy is generally reserved for patients with more moderate-to-severe psoriasis, often defined as BSA ≥10% or PASI of ≥10. Notably, these criteria are all clinician-performed. The Dermatology Life Quality Index (DLQI) measures the impact of the disease on the patient with a score of 0-5, 6-10, and 11-30 indicating mild, moderate, and severe disease, respectively. In a cross-sectional, observational study, 72.4% of psoriasis patients who qualified for systemic therapy initiation based on PASI and/or BSA had a DLQI of less than 10. Conversely, 10.4% of patients with a DLQI score higher than 10 did not qualify for systemic therapy based on PASI and/or BSA. This study highlights the complementary value of considering both clinician and patient determinants of disease severity when choosing a psoriasis therapy (Barbieri JS et al.)

With so many therapeutic options, it is increasingly common for patients to switch from one biologic to another. Many factors that go into the decision to switch therapies. A retrospective study of 115 adult patients with psoriasis found that the primary factor driving switching was lack of sufficient efficacy in treating skin disease. Having concomitant psoriatic arthritis increased the likelihood of switching by 2.69-fold (Akdogan N et al.). These findings suggest that shared decision making with dermatology, rheumatology, and the patient may help in choosing a treatment plan that best addresses both skin and joints.

One consideration when counseling patients about their likelihood of response to a second or third biologic is that in several clinical trials, biologic-naïve patients tend to have higher PASI responses to biologics than do heavier and biologic-experienced patients. A recent retrospective study found that receiving one or more biologic receiving was associated with a lower likelihood of achieving a PASI75 response to guselkumab (Hung YT et al.). However, in a real-life multicenter study including 57 adult patients with moderate-to-severe psoriasis receiving risankizumab, more biologic-experienced patients reached PASI 100 at weeks 36 and 52 (71.8% and 69.2%, respectively) compared with biologic-naïve patients (50.0% and 37.5%, respectively) (Gerdes S et al.). While both studies were small and no firm conclusions or comparisons can be drawn, real-world data from large multicenter studies that evaluate multiple therapies may guide us in choosing the best therapy for challenging patients who are often underrepresented in clinical trials. Understanding how switching within vs. between classes (TNF, IL-17, and IL-23 inhibitors) impacts efficacy will also help in making choices about biologic switches.

Biologic therapy is generally reserved for patients with more moderate-to-severe psoriasis, often defined as BSA ≥10% or PASI of ≥10. Notably, these criteria are all clinician-performed. The Dermatology Life Quality Index (DLQI) measures the impact of the disease on the patient with a score of 0-5, 6-10, and 11-30 indicating mild, moderate, and severe disease, respectively. In a cross-sectional, observational study, 72.4% of psoriasis patients who qualified for systemic therapy initiation based on PASI and/or BSA had a DLQI of less than 10. Conversely, 10.4% of patients with a DLQI score higher than 10 did not qualify for systemic therapy based on PASI and/or BSA. This study highlights the complementary value of considering both clinician and patient determinants of disease severity when choosing a psoriasis therapy (Barbieri JS et al.)

With so many therapeutic options, it is increasingly common for patients to switch from one biologic to another. Many factors that go into the decision to switch therapies. A retrospective study of 115 adult patients with psoriasis found that the primary factor driving switching was lack of sufficient efficacy in treating skin disease. Having concomitant psoriatic arthritis increased the likelihood of switching by 2.69-fold (Akdogan N et al.). These findings suggest that shared decision making with dermatology, rheumatology, and the patient may help in choosing a treatment plan that best addresses both skin and joints.

One consideration when counseling patients about their likelihood of response to a second or third biologic is that in several clinical trials, biologic-naïve patients tend to have higher PASI responses to biologics than do heavier and biologic-experienced patients. A recent retrospective study found that receiving one or more biologic receiving was associated with a lower likelihood of achieving a PASI75 response to guselkumab (Hung YT et al.). However, in a real-life multicenter study including 57 adult patients with moderate-to-severe psoriasis receiving risankizumab, more biologic-experienced patients reached PASI 100 at weeks 36 and 52 (71.8% and 69.2%, respectively) compared with biologic-naïve patients (50.0% and 37.5%, respectively) (Gerdes S et al.). While both studies were small and no firm conclusions or comparisons can be drawn, real-world data from large multicenter studies that evaluate multiple therapies may guide us in choosing the best therapy for challenging patients who are often underrepresented in clinical trials. Understanding how switching within vs. between classes (TNF, IL-17, and IL-23 inhibitors) impacts efficacy will also help in making choices about biologic switches.

It is likely that the polypoid appearance of the colonic lining is a result of chronic inflammation of longstanding Crohn disease with an ileocolonic manifestation. Crohn disease is an idiopathic, chronic inflammatory bowel disease characterized by cycles of relapse and remission. These asymptomatic periods can last for several months up to a few years, as reported by the patient in this case. Up to 50% of cases of Crohn disease are characterized by ileocolitis, or inflammation of the ileum and the colon. Although postinflammatory polyps are a cancer risk factor for inflammatory bowel disease and pseudopolyps are associated with severe disease, their appearance is not necessarily a poor prognostic factor.

When assessing ongoing disease activity in ileocolonic Crohn disease or ulcerative colitis, colonoscopy represents the first-line approach. Endoscopic visualization and biopsy are critical components of the diagnosis. Alternatively, cross-sectional imaging can be used to assess disease phenotype. In addition, plain radiography or a CT scan of the abdomen can identify bowel obstruction and scanning of the pelvis can detect any intra-abdominal abscesses. Ulcerative colitis looms large in the differential diagnosis. Although weight loss, perineal disease, fistulae, and obstruction are common in Crohn disease, they are uncommon or rare in ulcerative colitis, although bleeding is observed much more frequently in ulcerative colitis. 

Treatment of Crohn disease is based on the severity, location, and subtype (inflammatory, stricturing, or penetrating). There is also now a focus on determining which patients are at risk for a more severe disease course and may require earlier and more aggressive therapies. Crohn disease is primarily managed through the introduction of early immunosuppressive or combination therapy with biologic agents in high-risk patients, as well as complementary diet modification. Although most patients will ultimately undergo surgery, there is no curative approach, unlike in ulcerative colitis.

In its clinical care pathway, the American Gastroenterological Association supports a top-down approach to therapy for adult patients with moderate to severe luminal Crohn disease (defining moderate to severe disease as having a Crohn Disease Activity Index score of 220 or higher, or having a high risk of complications). This approach supports the early use of biologic agents, with or without immunomodulators, over a stepwise strategy. The patient’s response to this new regimen should be determined in the 12-week period after the initiation of therapy. Endoscopy or transmural responses to therapy should be assessed after 6 months.

Bhupinder S. Anand, MD, Professor, Department of Medicine, Baylor College of Medicine, Houston, TX

Bhupinder S. Anand, MD, has disclosed no relevant financial relationships.

It is likely that the polypoid appearance of the colonic lining is a result of chronic inflammation of longstanding Crohn disease with an ileocolonic manifestation. Crohn disease is an idiopathic, chronic inflammatory bowel disease characterized by cycles of relapse and remission. These asymptomatic periods can last for several months up to a few years, as reported by the patient in this case. Up to 50% of cases of Crohn disease are characterized by ileocolitis, or inflammation of the ileum and the colon. Although postinflammatory polyps are a cancer risk factor for inflammatory bowel disease and pseudopolyps are associated with severe disease, their appearance is not necessarily a poor prognostic factor.

When assessing ongoing disease activity in ileocolonic Crohn disease or ulcerative colitis, colonoscopy represents the first-line approach. Endoscopic visualization and biopsy are critical components of the diagnosis. Alternatively, cross-sectional imaging can be used to assess disease phenotype. In addition, plain radiography or a CT scan of the abdomen can identify bowel obstruction and scanning of the pelvis can detect any intra-abdominal abscesses. Ulcerative colitis looms large in the differential diagnosis. Although weight loss, perineal disease, fistulae, and obstruction are common in Crohn disease, they are uncommon or rare in ulcerative colitis, although bleeding is observed much more frequently in ulcerative colitis. 

Treatment of Crohn disease is based on the severity, location, and subtype (inflammatory, stricturing, or penetrating). There is also now a focus on determining which patients are at risk for a more severe disease course and may require earlier and more aggressive therapies. Crohn disease is primarily managed through the introduction of early immunosuppressive or combination therapy with biologic agents in high-risk patients, as well as complementary diet modification. Although most patients will ultimately undergo surgery, there is no curative approach, unlike in ulcerative colitis.

In its clinical care pathway, the American Gastroenterological Association supports a top-down approach to therapy for adult patients with moderate to severe luminal Crohn disease (defining moderate to severe disease as having a Crohn Disease Activity Index score of 220 or higher, or having a high risk of complications). This approach supports the early use of biologic agents, with or without immunomodulators, over a stepwise strategy. The patient’s response to this new regimen should be determined in the 12-week period after the initiation of therapy. Endoscopy or transmural responses to therapy should be assessed after 6 months.

Bhupinder S. Anand, MD, Professor, Department of Medicine, Baylor College of Medicine, Houston, TX

Bhupinder S. Anand, MD, has disclosed no relevant financial relationships.

It is likely that the polypoid appearance of the colonic lining is a result of chronic inflammation of longstanding Crohn disease with an ileocolonic manifestation. Crohn disease is an idiopathic, chronic inflammatory bowel disease characterized by cycles of relapse and remission. These asymptomatic periods can last for several months up to a few years, as reported by the patient in this case. Up to 50% of cases of Crohn disease are characterized by ileocolitis, or inflammation of the ileum and the colon. Although postinflammatory polyps are a cancer risk factor for inflammatory bowel disease and pseudopolyps are associated with severe disease, their appearance is not necessarily a poor prognostic factor.

When assessing ongoing disease activity in ileocolonic Crohn disease or ulcerative colitis, colonoscopy represents the first-line approach. Endoscopic visualization and biopsy are critical components of the diagnosis. Alternatively, cross-sectional imaging can be used to assess disease phenotype. In addition, plain radiography or a CT scan of the abdomen can identify bowel obstruction and scanning of the pelvis can detect any intra-abdominal abscesses. Ulcerative colitis looms large in the differential diagnosis. Although weight loss, perineal disease, fistulae, and obstruction are common in Crohn disease, they are uncommon or rare in ulcerative colitis, although bleeding is observed much more frequently in ulcerative colitis. 

Treatment of Crohn disease is based on the severity, location, and subtype (inflammatory, stricturing, or penetrating). There is also now a focus on determining which patients are at risk for a more severe disease course and may require earlier and more aggressive therapies. Crohn disease is primarily managed through the introduction of early immunosuppressive or combination therapy with biologic agents in high-risk patients, as well as complementary diet modification. Although most patients will ultimately undergo surgery, there is no curative approach, unlike in ulcerative colitis.

In its clinical care pathway, the American Gastroenterological Association supports a top-down approach to therapy for adult patients with moderate to severe luminal Crohn disease (defining moderate to severe disease as having a Crohn Disease Activity Index score of 220 or higher, or having a high risk of complications). This approach supports the early use of biologic agents, with or without immunomodulators, over a stepwise strategy. The patient’s response to this new regimen should be determined in the 12-week period after the initiation of therapy. Endoscopy or transmural responses to therapy should be assessed after 6 months.

Bhupinder S. Anand, MD, Professor, Department of Medicine, Baylor College of Medicine, Houston, TX

Bhupinder S. Anand, MD, has disclosed no relevant financial relationships.

The differential diagnosis of inflammatory bowel disease (IBD) in older patients is complicated by comorbid conditions such as infectious colitis, segmental colitis associated with diverticular disease, nonsteroidal anti-inflammatory drug-induced intestinal injury, and ischemia, each of which can mimic the intestinal inflammation characteristic of IBD. 

Ulcerative colitis is one of the two major types of IBD, along with Crohn disease. Unlike Crohn disease, which can affect any part of the gastrointestinal tract, ulcerative colitis characteristically causes inflammation in the large bowel (see image). 

Acute, severe ulcerative colitis (ie, > six bloody bowel movements per day, with one of the following: temperature > 38 °C [100.4 °F], hemoglobin level < 10.5 g/dL, heart rate > 90 beats/min, erythrocyte sedimentation rate > 30 mm/hr, or C-reactive protein level > 30 mg/dL) requires hospitalization and treatment with intravenous high-dose corticosteroids (hydrocortisone 400 mg/day or methylprednisolone 60 mg/day). 

The diagnosis of ulcerative colitis is best made with endoscopy and mucosal biopsy for histopathologic analysis. Characteristic findings are abnormal erythematous mucosa, with or without ulceration, extending from the rectum to a part or all of the colon; and uniform inflammation without intervening areas of normal mucosa (skip lesions tend to be characteristic of Crohn disease). Contact bleeding may also be observed, with mucus identified in the lumen of the bowel.

The bowel wall in a patient with ulcerative colitis is thin or of normal thickness, but edema, the accumulation of fat, and hypertrophy of the muscle layer may give the impression of a thickened bowel wall. The disease is largely confined to the mucosa and, to a lesser extent, the submucosa.

Laboratory studies are helpful to exclude other diagnoses and assess the patient's nutritional status, but serologic markers can help in the differential diagnosis of IBD. Radiographic imaging has an important role in the workup of patients with suspected IBD and in the differentiation of ulcerative colitis from Crohn disease by demonstrating fistulae or the presence of small bowel disease seen only in Crohn disease.

Much work in the past decade has focused on the development of serologic markers for inflammatory bowel disease. pANCA and anti–Saccharomyces cerevisiae antibodies (ASCA) have been the most intensely studied. The World Gastroenterology Organization states that ulcerative colitis is more likely when the test results are positive for pANCA and negative for ASCA antigen; however, the pANCA test result may be positive in patients with Crohn disease, and this may complicate obtaining a diagnosis in an otherwise uncomplicated colitis.

According to the American Gastroenterological Association, drug classes for the long-term management of moderate to severe ulcerative colitis include tumor necrosis factor-alpha antagonists, anti-integrin agent (vedolizumab), Janus kinase inhibitor (tofacitinib), interleukin-12/23 antagonist (ustekinumab), and immunomodulators (thiopurines, methotrexate). In general, most drugs that are initiated for the induction of remission are continued as maintenance therapy if they are effective.

Bhupinder S. Anand, MD, Professor, Department of Medicine, Baylor College of Medicine, Houston, TX

Bhupinder S. Anand, MD, has disclosed no relevant financial relationships.

The differential diagnosis of inflammatory bowel disease (IBD) in older patients is complicated by comorbid conditions such as infectious colitis, segmental colitis associated with diverticular disease, nonsteroidal anti-inflammatory drug-induced intestinal injury, and ischemia, each of which can mimic the intestinal inflammation characteristic of IBD. 

Ulcerative colitis is one of the two major types of IBD, along with Crohn disease. Unlike Crohn disease, which can affect any part of the gastrointestinal tract, ulcerative colitis characteristically causes inflammation in the large bowel (see image). 

Acute, severe ulcerative colitis (ie, > six bloody bowel movements per day, with one of the following: temperature > 38 °C [100.4 °F], hemoglobin level < 10.5 g/dL, heart rate > 90 beats/min, erythrocyte sedimentation rate > 30 mm/hr, or C-reactive protein level > 30 mg/dL) requires hospitalization and treatment with intravenous high-dose corticosteroids (hydrocortisone 400 mg/day or methylprednisolone 60 mg/day). 

The diagnosis of ulcerative colitis is best made with endoscopy and mucosal biopsy for histopathologic analysis. Characteristic findings are abnormal erythematous mucosa, with or without ulceration, extending from the rectum to a part or all of the colon; and uniform inflammation without intervening areas of normal mucosa (skip lesions tend to be characteristic of Crohn disease). Contact bleeding may also be observed, with mucus identified in the lumen of the bowel.

The bowel wall in a patient with ulcerative colitis is thin or of normal thickness, but edema, the accumulation of fat, and hypertrophy of the muscle layer may give the impression of a thickened bowel wall. The disease is largely confined to the mucosa and, to a lesser extent, the submucosa.

Laboratory studies are helpful to exclude other diagnoses and assess the patient's nutritional status, but serologic markers can help in the differential diagnosis of IBD. Radiographic imaging has an important role in the workup of patients with suspected IBD and in the differentiation of ulcerative colitis from Crohn disease by demonstrating fistulae or the presence of small bowel disease seen only in Crohn disease.

Much work in the past decade has focused on the development of serologic markers for inflammatory bowel disease. pANCA and anti–Saccharomyces cerevisiae antibodies (ASCA) have been the most intensely studied. The World Gastroenterology Organization states that ulcerative colitis is more likely when the test results are positive for pANCA and negative for ASCA antigen; however, the pANCA test result may be positive in patients with Crohn disease, and this may complicate obtaining a diagnosis in an otherwise uncomplicated colitis.

According to the American Gastroenterological Association, drug classes for the long-term management of moderate to severe ulcerative colitis include tumor necrosis factor-alpha antagonists, anti-integrin agent (vedolizumab), Janus kinase inhibitor (tofacitinib), interleukin-12/23 antagonist (ustekinumab), and immunomodulators (thiopurines, methotrexate). In general, most drugs that are initiated for the induction of remission are continued as maintenance therapy if they are effective.

Bhupinder S. Anand, MD, Professor, Department of Medicine, Baylor College of Medicine, Houston, TX

Bhupinder S. Anand, MD, has disclosed no relevant financial relationships.

The differential diagnosis of inflammatory bowel disease (IBD) in older patients is complicated by comorbid conditions such as infectious colitis, segmental colitis associated with diverticular disease, nonsteroidal anti-inflammatory drug-induced intestinal injury, and ischemia, each of which can mimic the intestinal inflammation characteristic of IBD. 

Ulcerative colitis is one of the two major types of IBD, along with Crohn disease. Unlike Crohn disease, which can affect any part of the gastrointestinal tract, ulcerative colitis characteristically causes inflammation in the large bowel (see image). 

Acute, severe ulcerative colitis (ie, > six bloody bowel movements per day, with one of the following: temperature > 38 °C [100.4 °F], hemoglobin level < 10.5 g/dL, heart rate > 90 beats/min, erythrocyte sedimentation rate > 30 mm/hr, or C-reactive protein level > 30 mg/dL) requires hospitalization and treatment with intravenous high-dose corticosteroids (hydrocortisone 400 mg/day or methylprednisolone 60 mg/day). 

The diagnosis of ulcerative colitis is best made with endoscopy and mucosal biopsy for histopathologic analysis. Characteristic findings are abnormal erythematous mucosa, with or without ulceration, extending from the rectum to a part or all of the colon; and uniform inflammation without intervening areas of normal mucosa (skip lesions tend to be characteristic of Crohn disease). Contact bleeding may also be observed, with mucus identified in the lumen of the bowel.

The bowel wall in a patient with ulcerative colitis is thin or of normal thickness, but edema, the accumulation of fat, and hypertrophy of the muscle layer may give the impression of a thickened bowel wall. The disease is largely confined to the mucosa and, to a lesser extent, the submucosa.

Laboratory studies are helpful to exclude other diagnoses and assess the patient's nutritional status, but serologic markers can help in the differential diagnosis of IBD. Radiographic imaging has an important role in the workup of patients with suspected IBD and in the differentiation of ulcerative colitis from Crohn disease by demonstrating fistulae or the presence of small bowel disease seen only in Crohn disease.

Much work in the past decade has focused on the development of serologic markers for inflammatory bowel disease. pANCA and anti–Saccharomyces cerevisiae antibodies (ASCA) have been the most intensely studied. The World Gastroenterology Organization states that ulcerative colitis is more likely when the test results are positive for pANCA and negative for ASCA antigen; however, the pANCA test result may be positive in patients with Crohn disease, and this may complicate obtaining a diagnosis in an otherwise uncomplicated colitis.

According to the American Gastroenterological Association, drug classes for the long-term management of moderate to severe ulcerative colitis include tumor necrosis factor-alpha antagonists, anti-integrin agent (vedolizumab), Janus kinase inhibitor (tofacitinib), interleukin-12/23 antagonist (ustekinumab), and immunomodulators (thiopurines, methotrexate). In general, most drugs that are initiated for the induction of remission are continued as maintenance therapy if they are effective.

Bhupinder S. Anand, MD, Professor, Department of Medicine, Baylor College of Medicine, Houston, TX

Bhupinder S. Anand, MD, has disclosed no relevant financial relationships.

Similarly, Lin et al report the results of an international study of adults from 99 countries, which utilized longitudinal mobile based surveys to examine risk factors associated with SARS-CoV-2 infection. The mobile surveys captured baseline characteristics and behaviors of participants, and data was reported out for the study period of March to October 2020 (before vaccines were available). Adjusting for demographics, education level, a proxy for occupational risk, as well as medical comorbidities, authors found that greater number of non-household contacts, attending events with 10 or more individuals and restaurant visits predicted higher risk of SARS-CoV-2. Alternatively, older age was associated with lower risk, likely because of the protective behaviors undertaken by many in the older age group.

Lastly, the RECoVERED Study (Wynberg, at al), based in Netherlands, followed recently diagnosed laboratory confirmed SARS-CoV-2 patients for a year, initially with three in person visits (where disease severity was determined based on vital signs and level of care needed) within the first month of illness and then monthly online surveys. Authors utilized a survey examining severity of 18 symptoms based on the World Health Organization Case Report Form. Authors found 86.7% of those with initial severe disease [95% confidence interval {CI} = 76.5–92.7%]), 63.8%  of those moderate disease 63.8% [95% CI = 54.8–71.5%], and 30.7% of those with mild disease [95% CI = 21.1–40.9%] had at least one persistent symptom at 12 weeks.  Fatigue was the most common symptom reported at 12 weeks overall, but among those with moderate and severe disease, dyspnea and myalgia also persisted frequently. After one years of follow up, about one-fifth still had one persistent symptom. Over half of those with initial severe disease reported symptom persistence (52.5% [95% CI = 38.0–65.1%]). In a multivariable Cox proportional hazard model, female sex and higher BMI were associated with slower recovery. One limitation of the study was that was no control group recruited.

Similarly, Lin et al report the results of an international study of adults from 99 countries, which utilized longitudinal mobile based surveys to examine risk factors associated with SARS-CoV-2 infection. The mobile surveys captured baseline characteristics and behaviors of participants, and data was reported out for the study period of March to October 2020 (before vaccines were available). Adjusting for demographics, education level, a proxy for occupational risk, as well as medical comorbidities, authors found that greater number of non-household contacts, attending events with 10 or more individuals and restaurant visits predicted higher risk of SARS-CoV-2. Alternatively, older age was associated with lower risk, likely because of the protective behaviors undertaken by many in the older age group.

Lastly, the RECoVERED Study (Wynberg, at al), based in Netherlands, followed recently diagnosed laboratory confirmed SARS-CoV-2 patients for a year, initially with three in person visits (where disease severity was determined based on vital signs and level of care needed) within the first month of illness and then monthly online surveys. Authors utilized a survey examining severity of 18 symptoms based on the World Health Organization Case Report Form. Authors found 86.7% of those with initial severe disease [95% confidence interval {CI} = 76.5–92.7%]), 63.8%  of those moderate disease 63.8% [95% CI = 54.8–71.5%], and 30.7% of those with mild disease [95% CI = 21.1–40.9%] had at least one persistent symptom at 12 weeks.  Fatigue was the most common symptom reported at 12 weeks overall, but among those with moderate and severe disease, dyspnea and myalgia also persisted frequently. After one years of follow up, about one-fifth still had one persistent symptom. Over half of those with initial severe disease reported symptom persistence (52.5% [95% CI = 38.0–65.1%]). In a multivariable Cox proportional hazard model, female sex and higher BMI were associated with slower recovery. One limitation of the study was that was no control group recruited.

Similarly, Lin et al report the results of an international study of adults from 99 countries, which utilized longitudinal mobile based surveys to examine risk factors associated with SARS-CoV-2 infection. The mobile surveys captured baseline characteristics and behaviors of participants, and data was reported out for the study period of March to October 2020 (before vaccines were available). Adjusting for demographics, education level, a proxy for occupational risk, as well as medical comorbidities, authors found that greater number of non-household contacts, attending events with 10 or more individuals and restaurant visits predicted higher risk of SARS-CoV-2. Alternatively, older age was associated with lower risk, likely because of the protective behaviors undertaken by many in the older age group.

Lastly, the RECoVERED Study (Wynberg, at al), based in Netherlands, followed recently diagnosed laboratory confirmed SARS-CoV-2 patients for a year, initially with three in person visits (where disease severity was determined based on vital signs and level of care needed) within the first month of illness and then monthly online surveys. Authors utilized a survey examining severity of 18 symptoms based on the World Health Organization Case Report Form. Authors found 86.7% of those with initial severe disease [95% confidence interval {CI} = 76.5–92.7%]), 63.8%  of those moderate disease 63.8% [95% CI = 54.8–71.5%], and 30.7% of those with mild disease [95% CI = 21.1–40.9%] had at least one persistent symptom at 12 weeks.  Fatigue was the most common symptom reported at 12 weeks overall, but among those with moderate and severe disease, dyspnea and myalgia also persisted frequently. After one years of follow up, about one-fifth still had one persistent symptom. Over half of those with initial severe disease reported symptom persistence (52.5% [95% CI = 38.0–65.1%]). In a multivariable Cox proportional hazard model, female sex and higher BMI were associated with slower recovery. One limitation of the study was that was no control group recruited.

Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.

Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.

But there’s nothing she can do. The ER’s 72 rooms are already filled.

“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.

The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.

But now, they’re too full. Even in parts of the country where covid isn’t overwhelming the health system, patients are showing up to the ER sicker than before the pandemic, their diseases more advanced and in need of more complicated care.

Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.

But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.

Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.

At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.

Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.

“We could have done the physical in the parking lot,” he added, managing a laugh.

Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.

“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”

ER patients have grown sicker

“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”

Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.

“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.

Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.

So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.

Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”

At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.

But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.

“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”

The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”

“This is not humane care,” Dr. Moreno said. “This is horrible care.”

But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.

“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”

The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.

“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”

And already-overwhelmed staffers are burning out.

Burnout feeds staffing shortages, and vice versa

Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.

“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.

Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.

Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.

She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.

Finally, after many hours, they found an ambulance to take him home.

Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.

“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”

Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.

“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.

“Already tried,” replied nurse Troy Latunski.

Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.

But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.

Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.

“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.

Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.

Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.

But there’s nothing she can do. The ER’s 72 rooms are already filled.

“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.

The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.

But now, they’re too full. Even in parts of the country where covid isn’t overwhelming the health system, patients are showing up to the ER sicker than before the pandemic, their diseases more advanced and in need of more complicated care.

Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.

But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.

Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.

At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.

Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.

“We could have done the physical in the parking lot,” he added, managing a laugh.

Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.

“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”

ER patients have grown sicker

“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”

Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.

“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.

Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.

So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.

Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”

At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.

But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.

“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”

The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”

“This is not humane care,” Dr. Moreno said. “This is horrible care.”

But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.

“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”

The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.

“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”

And already-overwhelmed staffers are burning out.

Burnout feeds staffing shortages, and vice versa

Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.

“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.

Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.

Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.

She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.

Finally, after many hours, they found an ambulance to take him home.

Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.

“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”

Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.

“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.

“Already tried,” replied nurse Troy Latunski.

Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.

But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.

Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.

“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.

Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.

Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.

But there’s nothing she can do. The ER’s 72 rooms are already filled.

“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.

The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.

But now, they’re too full. Even in parts of the country where covid isn’t overwhelming the health system, patients are showing up to the ER sicker than before the pandemic, their diseases more advanced and in need of more complicated care.

Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.

But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.

Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.

At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.

Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.

“We could have done the physical in the parking lot,” he added, managing a laugh.

Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.

“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”

ER patients have grown sicker

“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”

Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.

“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.

Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.

So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.

Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”

At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.

But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.

“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”

The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”

“This is not humane care,” Dr. Moreno said. “This is horrible care.”

But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.

“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”

The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.

“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”

And already-overwhelmed staffers are burning out.

Burnout feeds staffing shortages, and vice versa

Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.

“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.

Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.

Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.

She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.

Finally, after many hours, they found an ambulance to take him home.

Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.

“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”

Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.

“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.

“Already tried,” replied nurse Troy Latunski.

Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.

But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.

Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.

“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.

Sigmoid colon perforation secondary to transcutaneous epicardial pacer wires.

A plain film image (Figure A) shows diffusely dilated loops of bowel with subdiaphragmatic air concerning for GI viscous perforation. Dedicated cross-sectional imaging confirms intra-abdominal free air, and in representative cross section, the epicardial pacing wires can be visualized within the gastrointestinal lumen (Figure D, arrows). At the time of surgical consultation, the radiology report was notable for concern regarding possible disruption of peritoneum secondary to the difficult surgical chest tube placement in a patient with a high-riding left hemidiaphragm. Urgent laparoscopic exploration secondary to these findings unexpectedly revealed that the transcutaneous epicardial pacing wires had been inadvertently placed through the sigmoid colon (Figure C). The pacer wires were cut and removed intraoperatively. Unfortunately, 4 days after removal of pacer wires, the patient continued to have ongoing distension and was found to have sigmoid volvulus necessitating endoscopic decompression. After a prolonged hospitalization and recovery, he was discharged with a normal bowel pattern and tolerating oral intake to a skilled nursing facility.

Temporary transcutaneous epicardial pacing wires are often placed after complex cardiovascular surgical procedures. Complications from wire placement are thought to be relatively rare and are typically associated with migration into local structures after wire placement and infectious complications secondary to retained wires.^1,2 Perforation of local structures during placement is less common, and GI viscous perforation in particular is not a well-characterized cause of associated morbidity.³

Our case demonstrates that, in patients with hemidiaphragm elevation, epicardial wire placement risks GI viscous perforation. Furthermore, given the frequency of concomitant surgical hardware in this patient population, identification of malpositioned epicardial wires on plain film and even cross-sectional imaging can be difficult and can delay diagnosis.

References

1. Del Nido P, Goldman BS. J Card Surg. 1989 Mar;4(1):99-103.

2. Kapoor A et al. Interact Cardiovasc Thorac Surg. 2011 Jul;13(1):104-6.

3. Haba J et al. Can Assoc Radiol J. 2013 Feb;64(1):77-80.

Sigmoid colon perforation secondary to transcutaneous epicardial pacer wires.

A plain film image (Figure A) shows diffusely dilated loops of bowel with subdiaphragmatic air concerning for GI viscous perforation. Dedicated cross-sectional imaging confirms intra-abdominal free air, and in representative cross section, the epicardial pacing wires can be visualized within the gastrointestinal lumen (Figure D, arrows). At the time of surgical consultation, the radiology report was notable for concern regarding possible disruption of peritoneum secondary to the difficult surgical chest tube placement in a patient with a high-riding left hemidiaphragm. Urgent laparoscopic exploration secondary to these findings unexpectedly revealed that the transcutaneous epicardial pacing wires had been inadvertently placed through the sigmoid colon (Figure C). The pacer wires were cut and removed intraoperatively. Unfortunately, 4 days after removal of pacer wires, the patient continued to have ongoing distension and was found to have sigmoid volvulus necessitating endoscopic decompression. After a prolonged hospitalization and recovery, he was discharged with a normal bowel pattern and tolerating oral intake to a skilled nursing facility.

Temporary transcutaneous epicardial pacing wires are often placed after complex cardiovascular surgical procedures. Complications from wire placement are thought to be relatively rare and are typically associated with migration into local structures after wire placement and infectious complications secondary to retained wires.^1,2 Perforation of local structures during placement is less common, and GI viscous perforation in particular is not a well-characterized cause of associated morbidity.³

Our case demonstrates that, in patients with hemidiaphragm elevation, epicardial wire placement risks GI viscous perforation. Furthermore, given the frequency of concomitant surgical hardware in this patient population, identification of malpositioned epicardial wires on plain film and even cross-sectional imaging can be difficult and can delay diagnosis.

References

1. Del Nido P, Goldman BS. J Card Surg. 1989 Mar;4(1):99-103.

2. Kapoor A et al. Interact Cardiovasc Thorac Surg. 2011 Jul;13(1):104-6.

3. Haba J et al. Can Assoc Radiol J. 2013 Feb;64(1):77-80.

Sigmoid colon perforation secondary to transcutaneous epicardial pacer wires.

A plain film image (Figure A) shows diffusely dilated loops of bowel with subdiaphragmatic air concerning for GI viscous perforation. Dedicated cross-sectional imaging confirms intra-abdominal free air, and in representative cross section, the epicardial pacing wires can be visualized within the gastrointestinal lumen (Figure D, arrows). At the time of surgical consultation, the radiology report was notable for concern regarding possible disruption of peritoneum secondary to the difficult surgical chest tube placement in a patient with a high-riding left hemidiaphragm. Urgent laparoscopic exploration secondary to these findings unexpectedly revealed that the transcutaneous epicardial pacing wires had been inadvertently placed through the sigmoid colon (Figure C). The pacer wires were cut and removed intraoperatively. Unfortunately, 4 days after removal of pacer wires, the patient continued to have ongoing distension and was found to have sigmoid volvulus necessitating endoscopic decompression. After a prolonged hospitalization and recovery, he was discharged with a normal bowel pattern and tolerating oral intake to a skilled nursing facility.

Temporary transcutaneous epicardial pacing wires are often placed after complex cardiovascular surgical procedures. Complications from wire placement are thought to be relatively rare and are typically associated with migration into local structures after wire placement and infectious complications secondary to retained wires.^1,2 Perforation of local structures during placement is less common, and GI viscous perforation in particular is not a well-characterized cause of associated morbidity.³

Our case demonstrates that, in patients with hemidiaphragm elevation, epicardial wire placement risks GI viscous perforation. Furthermore, given the frequency of concomitant surgical hardware in this patient population, identification of malpositioned epicardial wires on plain film and even cross-sectional imaging can be difficult and can delay diagnosis.

References

1. Del Nido P, Goldman BS. J Card Surg. 1989 Mar;4(1):99-103.

2. Kapoor A et al. Interact Cardiovasc Thorac Surg. 2011 Jul;13(1):104-6.

3. Haba J et al. Can Assoc Radiol J. 2013 Feb;64(1):77-80.

My office’s storage room has an old bankers box, which has been there since I moved 8 years ago. Before that it was at my other office, behind an old desk. I had no idea what was in it, I always assumed office supplies, surplus drug company pens and sticky notes, who-knows-whats.

Last week I had one of those days where everyone cancels, so I decided to investigate the box.

It was packed with 10 years worth (2000-2010) of my secretary’s MRI scheduling sheets that had somehow escaped occasional shredding purges. So I sat down next to the office shredder to get rid of them.

As I fed the sheets in, the names jumped out at me. Some I have absolutely no recollection of. Others I still see today.

There were names of the long-deceased, bringing them back to me for the first time in years. There were others that I have no idea what happened to – they must have just stopped seeing me at some point, though for the life of me I can’t remember when, or why. Yet, in my mind, there they were, as if I’d just seen them yesterday. A few times I got curious enough to turn back to my computer and look up their charts, trying to remember their stories.

Then there were those I still remember clearly, every single detail of, in spite of the elapsed time. Something about their case or personality had indelibly etched them in my memory. A valuable lesson learned from them that had something or nothing to do with medicine that’s still with me.

Looking back, I’d guess I’ve seen roughly 15,000-20,000 patients over my career. Not nearly as many as my colleagues in general practice, but still quite a few. A decent sized basketball arena full.

The majority don’t stick with you. That’s the way it is in life. We meet a lot of people as we walk down the road, but generally only remember those walking with us for a good part of it.

The ones we didn’t know long – but who are still clearly remembered – are also valuable. In their own way, perhaps unknowingly, they made an impact that hopefully makes us better.

For that I’ll always be grateful to them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

My office’s storage room has an old bankers box, which has been there since I moved 8 years ago. Before that it was at my other office, behind an old desk. I had no idea what was in it, I always assumed office supplies, surplus drug company pens and sticky notes, who-knows-whats.

Last week I had one of those days where everyone cancels, so I decided to investigate the box.

It was packed with 10 years worth (2000-2010) of my secretary’s MRI scheduling sheets that had somehow escaped occasional shredding purges. So I sat down next to the office shredder to get rid of them.

As I fed the sheets in, the names jumped out at me. Some I have absolutely no recollection of. Others I still see today.

There were names of the long-deceased, bringing them back to me for the first time in years. There were others that I have no idea what happened to – they must have just stopped seeing me at some point, though for the life of me I can’t remember when, or why. Yet, in my mind, there they were, as if I’d just seen them yesterday. A few times I got curious enough to turn back to my computer and look up their charts, trying to remember their stories.

Then there were those I still remember clearly, every single detail of, in spite of the elapsed time. Something about their case or personality had indelibly etched them in my memory. A valuable lesson learned from them that had something or nothing to do with medicine that’s still with me.

Looking back, I’d guess I’ve seen roughly 15,000-20,000 patients over my career. Not nearly as many as my colleagues in general practice, but still quite a few. A decent sized basketball arena full.

The majority don’t stick with you. That’s the way it is in life. We meet a lot of people as we walk down the road, but generally only remember those walking with us for a good part of it.

The ones we didn’t know long – but who are still clearly remembered – are also valuable. In their own way, perhaps unknowingly, they made an impact that hopefully makes us better.

For that I’ll always be grateful to them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

My office’s storage room has an old bankers box, which has been there since I moved 8 years ago. Before that it was at my other office, behind an old desk. I had no idea what was in it, I always assumed office supplies, surplus drug company pens and sticky notes, who-knows-whats.

Last week I had one of those days where everyone cancels, so I decided to investigate the box.

It was packed with 10 years worth (2000-2010) of my secretary’s MRI scheduling sheets that had somehow escaped occasional shredding purges. So I sat down next to the office shredder to get rid of them.

As I fed the sheets in, the names jumped out at me. Some I have absolutely no recollection of. Others I still see today.

There were names of the long-deceased, bringing them back to me for the first time in years. There were others that I have no idea what happened to – they must have just stopped seeing me at some point, though for the life of me I can’t remember when, or why. Yet, in my mind, there they were, as if I’d just seen them yesterday. A few times I got curious enough to turn back to my computer and look up their charts, trying to remember their stories.

Then there were those I still remember clearly, every single detail of, in spite of the elapsed time. Something about their case or personality had indelibly etched them in my memory. A valuable lesson learned from them that had something or nothing to do with medicine that’s still with me.

Looking back, I’d guess I’ve seen roughly 15,000-20,000 patients over my career. Not nearly as many as my colleagues in general practice, but still quite a few. A decent sized basketball arena full.

The majority don’t stick with you. That’s the way it is in life. We meet a lot of people as we walk down the road, but generally only remember those walking with us for a good part of it.

The ones we didn’t know long – but who are still clearly remembered – are also valuable. In their own way, perhaps unknowingly, they made an impact that hopefully makes us better.

For that I’ll always be grateful to them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Nearly one in three gay and bisexual men who were diagnosed with HIV at U.K. sexual health clinics didn’t meet the criteria for “high risk” that would signal to a clinician that they would be good candidates for pre-exposure prophylaxis (PrEP).

And that means that people who appear lower risk may still be good candidates for the HIV prevention pills, said Ann Sullivan, MD, consulting physician at Chelsea and Westminster Hospital, London.

“If people are coming forward for PrEP, they have self-identified that they need PrEP, [and] we should be allowing them to take PrEP,” said Dr. Sullivan at the 18th European AIDS Society Conference (EACS 2021). “We just need to trust patients. People know their risk, and we just have to accept that they know what they need best.”

And while this trial was made up of 95% gay and bisexual men, that ethos applies to every other group that could benefit from PrEP, including cisgender and transgender women and other gender-diverse people, Latinos, and Black Americans. In the United States, these groups make up nearly half of those who could benefit from PrEP under older guidelines but account for just 8% of people currently taking PrEP.

The finding also reinforces growing calls from health care providers to reduce gatekeeping around PrEP. For instance, there’s a move underway by the U.S. Centers for Disease Control and Prevention, where drafts of updated PrEP guidelines call for clinicians to talk to any sexually active teenager and adult about PrEP.

For the PrEP Impact trial, gay and bisexual men who received sexual health care at UK National Health Service sexual health clinics were invited to enroll in the study based on national PrEP guidelines. Those guidelines included being a cisgender man who had had sex with men not currently living with HIV and reporting condomless anal sex in the last 3 months; having a male partner whose HIV status they don’t know or who doesn’t have an undetectable viral load and with whom they’ve had condomless anal sex; or someone who doesn’t reach those criteria but whom the clinician thinks would be a good candidate.

Between Oct. 2017 and Feb. 2020, a total of 17,770 gay and bisexual men and 503 transgender or nonbinary people enrolled in the trial and were paired with 97,098 gay and bisexual men who didn’t use PrEP. (Data from the transgender participants were reported in a separate presentation.) The median age was 27 years, with 14.4% of the cisgender gay men between the ages of 16 and 24. Three out of four cis men were White, most lived in London, and more than half came from very-low-income neighborhoods.

Participants and controls were assessed for whether they were at particularly high risk for acquiring HIV, such as having used PrEP, having had two or more HIV tests, having had a rectal bacterial sexually transmitted infection (STI), or having had contact with someone with HIV or syphilis.

At the end of Feb. 2020, 24 cisgender men on PrEP had acquired HIV compared with 670 in the control group – an 87% reduction in HIV acquisition. Only one of those 24 cis men had lab-confirmed high adherence to PrEP. However, because the hair samples used to judge drug concentration weren’t long enough, Dr. Sullivan and colleagues were unable to assess whether the person really was fully adherent to treatment for the length of the trial.

But when they looked at the assessed behavior of people who acquired HIV, the two groups diverged. While a full 92% of people using PrEP had had STI diagnoses and other markers of increased risk, that was true for only 71% of people not taking PrEP. That meant, Dr. Sullivan said in an interview, that screening guidelines for PrEP were missing 29% of people with low assessed risk for HIV who nevertheless acquired the virus.

The findings led Antonio Urbina, MD, who both prescribes PrEP and manages Mount Sinai Medical Center’s PrEP program in New York, to the same conclusion that Dr. Sullivan and her team came to: that no screener is going to account for everything, and that there may be things that patients don’t want to tell their clinicians about their risk, either because of their own internalized stigma or their calculation that they aren’t comfortable enough with their providers to be honest.

“It reinforces to me that I need to ask more open-ended questions regarding risk and then just talk more about PrEP,” said Dr. Urbina, professor of medicine at Icahn School of Medicine. “Risk is dynamic and changes. And the great thing about PrEP is that if the risk goes up or down, if you have PrEP on board, you maintain this protection against HIV.”

An accompanying presentation on the transgender and nonbinary participants in the Impact Trial found that just one of 503 PrEP users acquired HIV. But here, too, there were people who could have benefited from PrEP but didn’t take it: Of the 477 trans and nonbinary participants who acted as controls, 97 were eligible by current guidelines but didn’t take PrEP. One in four of those declined the offer to take PrEP; the rest weren’t able to take it because they lived outside the treatment area. That, combined with a significantly lower likelihood that Black trans and nonbinary people took PrEP, indicated that work needs to be done to address the needs of people geographically and ethnically.

The data on gay men also raised the “who’s left out” issue for Gina Simoncini, MD, medical director for the Philadelphia AIDS Healthcare Foundation Healthcare Center. Dr. Simoncini previously taught attending physicians at Temple University how to prescribe PrEP and has done many grand rounds for primary care providers on how to manage PrEP.

“My biggest issue with this data is: What about the people who aren’t going to sexual health clinics?” she said. “What about the kid who’s 16 and maybe just barely putting his feet into the waters of sex and doesn’t feel quite comfortable going to a sexual health clinic? What about the trans Indian girl who can’t get to sexual health clinics because of family stigma and cultural stigma? The more we move toward primary care, the more people need to get on board with this.”

Dr. Sullivan reports no relevant financial relationships. Dr. Simoncini is an employee of AIDS Healthcare Foundation and has received advisory board fees from ViiV Healthcare. Dr. Urbina sits on the scientific advisory councils for Gilead Sciences, ViiV Healthcare, and Merck.

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

Nearly one in three gay and bisexual men who were diagnosed with HIV at U.K. sexual health clinics didn’t meet the criteria for “high risk” that would signal to a clinician that they would be good candidates for pre-exposure prophylaxis (PrEP).

And that means that people who appear lower risk may still be good candidates for the HIV prevention pills, said Ann Sullivan, MD, consulting physician at Chelsea and Westminster Hospital, London.

“If people are coming forward for PrEP, they have self-identified that they need PrEP, [and] we should be allowing them to take PrEP,” said Dr. Sullivan at the 18th European AIDS Society Conference (EACS 2021). “We just need to trust patients. People know their risk, and we just have to accept that they know what they need best.”

And while this trial was made up of 95% gay and bisexual men, that ethos applies to every other group that could benefit from PrEP, including cisgender and transgender women and other gender-diverse people, Latinos, and Black Americans. In the United States, these groups make up nearly half of those who could benefit from PrEP under older guidelines but account for just 8% of people currently taking PrEP.

The finding also reinforces growing calls from health care providers to reduce gatekeeping around PrEP. For instance, there’s a move underway by the U.S. Centers for Disease Control and Prevention, where drafts of updated PrEP guidelines call for clinicians to talk to any sexually active teenager and adult about PrEP.

For the PrEP Impact trial, gay and bisexual men who received sexual health care at UK National Health Service sexual health clinics were invited to enroll in the study based on national PrEP guidelines. Those guidelines included being a cisgender man who had had sex with men not currently living with HIV and reporting condomless anal sex in the last 3 months; having a male partner whose HIV status they don’t know or who doesn’t have an undetectable viral load and with whom they’ve had condomless anal sex; or someone who doesn’t reach those criteria but whom the clinician thinks would be a good candidate.

Between Oct. 2017 and Feb. 2020, a total of 17,770 gay and bisexual men and 503 transgender or nonbinary people enrolled in the trial and were paired with 97,098 gay and bisexual men who didn’t use PrEP. (Data from the transgender participants were reported in a separate presentation.) The median age was 27 years, with 14.4% of the cisgender gay men between the ages of 16 and 24. Three out of four cis men were White, most lived in London, and more than half came from very-low-income neighborhoods.

Participants and controls were assessed for whether they were at particularly high risk for acquiring HIV, such as having used PrEP, having had two or more HIV tests, having had a rectal bacterial sexually transmitted infection (STI), or having had contact with someone with HIV or syphilis.

At the end of Feb. 2020, 24 cisgender men on PrEP had acquired HIV compared with 670 in the control group – an 87% reduction in HIV acquisition. Only one of those 24 cis men had lab-confirmed high adherence to PrEP. However, because the hair samples used to judge drug concentration weren’t long enough, Dr. Sullivan and colleagues were unable to assess whether the person really was fully adherent to treatment for the length of the trial.

But when they looked at the assessed behavior of people who acquired HIV, the two groups diverged. While a full 92% of people using PrEP had had STI diagnoses and other markers of increased risk, that was true for only 71% of people not taking PrEP. That meant, Dr. Sullivan said in an interview, that screening guidelines for PrEP were missing 29% of people with low assessed risk for HIV who nevertheless acquired the virus.

The findings led Antonio Urbina, MD, who both prescribes PrEP and manages Mount Sinai Medical Center’s PrEP program in New York, to the same conclusion that Dr. Sullivan and her team came to: that no screener is going to account for everything, and that there may be things that patients don’t want to tell their clinicians about their risk, either because of their own internalized stigma or their calculation that they aren’t comfortable enough with their providers to be honest.

“It reinforces to me that I need to ask more open-ended questions regarding risk and then just talk more about PrEP,” said Dr. Urbina, professor of medicine at Icahn School of Medicine. “Risk is dynamic and changes. And the great thing about PrEP is that if the risk goes up or down, if you have PrEP on board, you maintain this protection against HIV.”

An accompanying presentation on the transgender and nonbinary participants in the Impact Trial found that just one of 503 PrEP users acquired HIV. But here, too, there were people who could have benefited from PrEP but didn’t take it: Of the 477 trans and nonbinary participants who acted as controls, 97 were eligible by current guidelines but didn’t take PrEP. One in four of those declined the offer to take PrEP; the rest weren’t able to take it because they lived outside the treatment area. That, combined with a significantly lower likelihood that Black trans and nonbinary people took PrEP, indicated that work needs to be done to address the needs of people geographically and ethnically.

The data on gay men also raised the “who’s left out” issue for Gina Simoncini, MD, medical director for the Philadelphia AIDS Healthcare Foundation Healthcare Center. Dr. Simoncini previously taught attending physicians at Temple University how to prescribe PrEP and has done many grand rounds for primary care providers on how to manage PrEP.

“My biggest issue with this data is: What about the people who aren’t going to sexual health clinics?” she said. “What about the kid who’s 16 and maybe just barely putting his feet into the waters of sex and doesn’t feel quite comfortable going to a sexual health clinic? What about the trans Indian girl who can’t get to sexual health clinics because of family stigma and cultural stigma? The more we move toward primary care, the more people need to get on board with this.”

Dr. Sullivan reports no relevant financial relationships. Dr. Simoncini is an employee of AIDS Healthcare Foundation and has received advisory board fees from ViiV Healthcare. Dr. Urbina sits on the scientific advisory councils for Gilead Sciences, ViiV Healthcare, and Merck.

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

Nearly one in three gay and bisexual men who were diagnosed with HIV at U.K. sexual health clinics didn’t meet the criteria for “high risk” that would signal to a clinician that they would be good candidates for pre-exposure prophylaxis (PrEP).

And that means that people who appear lower risk may still be good candidates for the HIV prevention pills, said Ann Sullivan, MD, consulting physician at Chelsea and Westminster Hospital, London.

“If people are coming forward for PrEP, they have self-identified that they need PrEP, [and] we should be allowing them to take PrEP,” said Dr. Sullivan at the 18th European AIDS Society Conference (EACS 2021). “We just need to trust patients. People know their risk, and we just have to accept that they know what they need best.”

And while this trial was made up of 95% gay and bisexual men, that ethos applies to every other group that could benefit from PrEP, including cisgender and transgender women and other gender-diverse people, Latinos, and Black Americans. In the United States, these groups make up nearly half of those who could benefit from PrEP under older guidelines but account for just 8% of people currently taking PrEP.

The finding also reinforces growing calls from health care providers to reduce gatekeeping around PrEP. For instance, there’s a move underway by the U.S. Centers for Disease Control and Prevention, where drafts of updated PrEP guidelines call for clinicians to talk to any sexually active teenager and adult about PrEP.

For the PrEP Impact trial, gay and bisexual men who received sexual health care at UK National Health Service sexual health clinics were invited to enroll in the study based on national PrEP guidelines. Those guidelines included being a cisgender man who had had sex with men not currently living with HIV and reporting condomless anal sex in the last 3 months; having a male partner whose HIV status they don’t know or who doesn’t have an undetectable viral load and with whom they’ve had condomless anal sex; or someone who doesn’t reach those criteria but whom the clinician thinks would be a good candidate.

Between Oct. 2017 and Feb. 2020, a total of 17,770 gay and bisexual men and 503 transgender or nonbinary people enrolled in the trial and were paired with 97,098 gay and bisexual men who didn’t use PrEP. (Data from the transgender participants were reported in a separate presentation.) The median age was 27 years, with 14.4% of the cisgender gay men between the ages of 16 and 24. Three out of four cis men were White, most lived in London, and more than half came from very-low-income neighborhoods.

Participants and controls were assessed for whether they were at particularly high risk for acquiring HIV, such as having used PrEP, having had two or more HIV tests, having had a rectal bacterial sexually transmitted infection (STI), or having had contact with someone with HIV or syphilis.

At the end of Feb. 2020, 24 cisgender men on PrEP had acquired HIV compared with 670 in the control group – an 87% reduction in HIV acquisition. Only one of those 24 cis men had lab-confirmed high adherence to PrEP. However, because the hair samples used to judge drug concentration weren’t long enough, Dr. Sullivan and colleagues were unable to assess whether the person really was fully adherent to treatment for the length of the trial.

But when they looked at the assessed behavior of people who acquired HIV, the two groups diverged. While a full 92% of people using PrEP had had STI diagnoses and other markers of increased risk, that was true for only 71% of people not taking PrEP. That meant, Dr. Sullivan said in an interview, that screening guidelines for PrEP were missing 29% of people with low assessed risk for HIV who nevertheless acquired the virus.

The findings led Antonio Urbina, MD, who both prescribes PrEP and manages Mount Sinai Medical Center’s PrEP program in New York, to the same conclusion that Dr. Sullivan and her team came to: that no screener is going to account for everything, and that there may be things that patients don’t want to tell their clinicians about their risk, either because of their own internalized stigma or their calculation that they aren’t comfortable enough with their providers to be honest.

“It reinforces to me that I need to ask more open-ended questions regarding risk and then just talk more about PrEP,” said Dr. Urbina, professor of medicine at Icahn School of Medicine. “Risk is dynamic and changes. And the great thing about PrEP is that if the risk goes up or down, if you have PrEP on board, you maintain this protection against HIV.”

An accompanying presentation on the transgender and nonbinary participants in the Impact Trial found that just one of 503 PrEP users acquired HIV. But here, too, there were people who could have benefited from PrEP but didn’t take it: Of the 477 trans and nonbinary participants who acted as controls, 97 were eligible by current guidelines but didn’t take PrEP. One in four of those declined the offer to take PrEP; the rest weren’t able to take it because they lived outside the treatment area. That, combined with a significantly lower likelihood that Black trans and nonbinary people took PrEP, indicated that work needs to be done to address the needs of people geographically and ethnically.

The data on gay men also raised the “who’s left out” issue for Gina Simoncini, MD, medical director for the Philadelphia AIDS Healthcare Foundation Healthcare Center. Dr. Simoncini previously taught attending physicians at Temple University how to prescribe PrEP and has done many grand rounds for primary care providers on how to manage PrEP.

“My biggest issue with this data is: What about the people who aren’t going to sexual health clinics?” she said. “What about the kid who’s 16 and maybe just barely putting his feet into the waters of sex and doesn’t feel quite comfortable going to a sexual health clinic? What about the trans Indian girl who can’t get to sexual health clinics because of family stigma and cultural stigma? The more we move toward primary care, the more people need to get on board with this.”

Dr. Sullivan reports no relevant financial relationships. Dr. Simoncini is an employee of AIDS Healthcare Foundation and has received advisory board fees from ViiV Healthcare. Dr. Urbina sits on the scientific advisory councils for Gilead Sciences, ViiV Healthcare, and Merck.

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

One year into offering the first long-acting injectable HIV treatment to his patients, Jonathan Angel, MD, head of the division of infectious diseases at the University of Ottawa, reported that 15 of the 21 of patients who started on the regimen are still taking it, all with viral suppression. Those who weren’t cited a combination of inconvenience, injection site pain, and “injection fatigue.”

These are just a few things HIV providers are learning as they begin what Chloe Orkin, MD, professor of HIV medicine at Queen Mary University of London, called a paradigm shift to long-acting treatment, which may soon include not just shots but rings, implants, and microarray patches.

“It’s a paradigm shift, and we are at the very beginning of this paradigm shift,” said Dr. Orkin, commenting during the discussion session of the European AIDS Clinical Society 2021 annual meeting. “We’re having to change our model, and it’s challenging.”

In the United States, the Food and Drug Administration approved the first long-acting injectable, a combination of cabotegravir and rilpivirine (CAB/RIL; Cabenuva, ViiV Healthcare) in January 2021. But it has been approved in Canada since March 2020 and available at Dr. Angel’s clinic since November 2020. It’s also available in Canada as an every-other-month shot. Injected into the buttocks, the shot was found to be noninferior to standard daily oral treatment in many studies, including the ATLAS, the ATLAS-2M – which tested the every-other-month approach – and FLAIR trials.

Dr. Angel’s clinic was part of all three of those trials, so his clinic has had 5 years’ experience preparing for the change in workflow and the new approach the shots require.

Of the 21 people Dr. Angel has treated, 11 were white Canadians, nine were Black African, and one was Indigenous Canadian, with women making up a third of the participants. Median age was 51 years, and all patients had had undetectable viral loads before beginning the regimen. (Studies of the drug’s effectiveness in people who struggle to take daily pills are still ongoing.)

Most of those 21 patients had had undetectable viral loads for more than 5 years, but a few had been undetectable for only 6 months before beginning the shots. Their immune systems were also healthy, with a median CD4 count of 618 cells/mcL. As in the clinical trials, none of the participants had experienced antiretroviral treatment failure. Because public health insurers in Canada have yet to approve the shots, Dr. Angel’s patients receiving Cabenuva also have private health insurance. Up to 90% of people in Canada receive pharmaceutical coverage through public insurance; therefore, the shot is not yet widely available.

Twenty patients switched from integrase-inhibitor regimens, and one had been receiving a nonnucleoside reverse transcriptase inhibitor–based regimen before starting Cabenuva.

And although the drug has not been approved for shot initiation this way, two patients requested – and Dr. Angel agreed – to start them on the shots without first doing a month of daily pills to check for safety.

“This is my conclusion from these data: the oral lead-in period is not necessary,” Dr. Angel said in his presentation at the meeting. “It can provide some comfort to either a physician or a patient, but it does not seem to be medically necessary.”

That approach is not without data to back it up. Research presented at HIV Glasgow 2020 showed that people who switched from daily oral dolutegravir/abacavir/lamivudine straight to the injections did so without problems.

At last clinic visit, 15 of those 21 were still receiving the shots. None have experienced treatment failure, and all were still virally suppressed. Four participants left the trials and one more person opted to return to daily pills, citing some level of what Dr. Angel called “injection fatigue.”

“Just as we use the term ‘pill fatigue’ for patients who are tired of taking pills, patients do get tired of coming in monthly for their visits and injections,” he said. They find the trip to the clinic for the intramuscular injections “inconvenient,” he said.

Unlike in the United States, where Cabenuva is approved for only monthly injections, Health Canada has already approved the shot for every-other-month injections, which Dr. Angel said may reduce the odds of injection fatigue.

Dr. Angel’s presentation drew comments, questions, and excitement from the crowd. Annemarie Wensing, MD, assistant professor of medicine at University Medical Center Utrecht (the Netherlands), asked whether dispensing with the oral lead-in period could mean that these shots could be useful for people going on longer trips, people having surgeries where they can’t swallow pills, or in other scenarios.

“These are not hypothetical conversations,” Dr. Angel said. “I’m having these conversations with patients now – temporary use, they travel for 3 months and come back, can they go from injectable to oral to injectable.”

For now, he said, the answer is, “We’ll figure it out.”

Meanwhile, there’s another big question when it comes to injectables, said Marta Vas ylyev, MD, from Lviv (Ukraine) Regional AIDS Center: When will they be available to the people who might benefit most from them – people in resource-limited settings, people who so far have struggled to remember to take their pills every day?

For now, Dr. Angel replied, injectables continue to be a treatment only for those who are already doing well while receiving HIV treatment: those with already suppressed viral load, who are good at taking daily pills, and who are being treated at well-resourced clinics.

“There are huge obstacles to overcome if this is ever to be available [in resource-limited settings], and way more obstacles than there are with any oral therapies,” he said. “There’s not been much discussion here about the necessity of cold-chain requirements of pharmacies either centrally or locally, [or] the requirements of additional nurses or health care staff to administer the medication. So you’re looking at a very resource-intensive therapy, which now is fairly restrictive [as to] who will have access to it.”

Dr. Angel reports serving on advisory boards for ViiV Healthcare and Gilead Sciences and has done contract research for ViiV Healthcare, Gilead, and Merck. Dr. Orkin has received research grants, fees as a consultant, travel sponsorship, and speaker fees from ViiV, Merck, and GlaxoSmithKline. Dr. Vasylyev reported no relevant financial relationships.  

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

One year into offering the first long-acting injectable HIV treatment to his patients, Jonathan Angel, MD, head of the division of infectious diseases at the University of Ottawa, reported that 15 of the 21 of patients who started on the regimen are still taking it, all with viral suppression. Those who weren’t cited a combination of inconvenience, injection site pain, and “injection fatigue.”

These are just a few things HIV providers are learning as they begin what Chloe Orkin, MD, professor of HIV medicine at Queen Mary University of London, called a paradigm shift to long-acting treatment, which may soon include not just shots but rings, implants, and microarray patches.

“It’s a paradigm shift, and we are at the very beginning of this paradigm shift,” said Dr. Orkin, commenting during the discussion session of the European AIDS Clinical Society 2021 annual meeting. “We’re having to change our model, and it’s challenging.”

In the United States, the Food and Drug Administration approved the first long-acting injectable, a combination of cabotegravir and rilpivirine (CAB/RIL; Cabenuva, ViiV Healthcare) in January 2021. But it has been approved in Canada since March 2020 and available at Dr. Angel’s clinic since November 2020. It’s also available in Canada as an every-other-month shot. Injected into the buttocks, the shot was found to be noninferior to standard daily oral treatment in many studies, including the ATLAS, the ATLAS-2M – which tested the every-other-month approach – and FLAIR trials.

Dr. Angel’s clinic was part of all three of those trials, so his clinic has had 5 years’ experience preparing for the change in workflow and the new approach the shots require.

Of the 21 people Dr. Angel has treated, 11 were white Canadians, nine were Black African, and one was Indigenous Canadian, with women making up a third of the participants. Median age was 51 years, and all patients had had undetectable viral loads before beginning the regimen. (Studies of the drug’s effectiveness in people who struggle to take daily pills are still ongoing.)

Most of those 21 patients had had undetectable viral loads for more than 5 years, but a few had been undetectable for only 6 months before beginning the shots. Their immune systems were also healthy, with a median CD4 count of 618 cells/mcL. As in the clinical trials, none of the participants had experienced antiretroviral treatment failure. Because public health insurers in Canada have yet to approve the shots, Dr. Angel’s patients receiving Cabenuva also have private health insurance. Up to 90% of people in Canada receive pharmaceutical coverage through public insurance; therefore, the shot is not yet widely available.

Twenty patients switched from integrase-inhibitor regimens, and one had been receiving a nonnucleoside reverse transcriptase inhibitor–based regimen before starting Cabenuva.

And although the drug has not been approved for shot initiation this way, two patients requested – and Dr. Angel agreed – to start them on the shots without first doing a month of daily pills to check for safety.

“This is my conclusion from these data: the oral lead-in period is not necessary,” Dr. Angel said in his presentation at the meeting. “It can provide some comfort to either a physician or a patient, but it does not seem to be medically necessary.”

That approach is not without data to back it up. Research presented at HIV Glasgow 2020 showed that people who switched from daily oral dolutegravir/abacavir/lamivudine straight to the injections did so without problems.

At last clinic visit, 15 of those 21 were still receiving the shots. None have experienced treatment failure, and all were still virally suppressed. Four participants left the trials and one more person opted to return to daily pills, citing some level of what Dr. Angel called “injection fatigue.”

“Just as we use the term ‘pill fatigue’ for patients who are tired of taking pills, patients do get tired of coming in monthly for their visits and injections,” he said. They find the trip to the clinic for the intramuscular injections “inconvenient,” he said.

Unlike in the United States, where Cabenuva is approved for only monthly injections, Health Canada has already approved the shot for every-other-month injections, which Dr. Angel said may reduce the odds of injection fatigue.

Dr. Angel’s presentation drew comments, questions, and excitement from the crowd. Annemarie Wensing, MD, assistant professor of medicine at University Medical Center Utrecht (the Netherlands), asked whether dispensing with the oral lead-in period could mean that these shots could be useful for people going on longer trips, people having surgeries where they can’t swallow pills, or in other scenarios.

“These are not hypothetical conversations,” Dr. Angel said. “I’m having these conversations with patients now – temporary use, they travel for 3 months and come back, can they go from injectable to oral to injectable.”

For now, he said, the answer is, “We’ll figure it out.”

Meanwhile, there’s another big question when it comes to injectables, said Marta Vas ylyev, MD, from Lviv (Ukraine) Regional AIDS Center: When will they be available to the people who might benefit most from them – people in resource-limited settings, people who so far have struggled to remember to take their pills every day?

For now, Dr. Angel replied, injectables continue to be a treatment only for those who are already doing well while receiving HIV treatment: those with already suppressed viral load, who are good at taking daily pills, and who are being treated at well-resourced clinics.

“There are huge obstacles to overcome if this is ever to be available [in resource-limited settings], and way more obstacles than there are with any oral therapies,” he said. “There’s not been much discussion here about the necessity of cold-chain requirements of pharmacies either centrally or locally, [or] the requirements of additional nurses or health care staff to administer the medication. So you’re looking at a very resource-intensive therapy, which now is fairly restrictive [as to] who will have access to it.”

Dr. Angel reports serving on advisory boards for ViiV Healthcare and Gilead Sciences and has done contract research for ViiV Healthcare, Gilead, and Merck. Dr. Orkin has received research grants, fees as a consultant, travel sponsorship, and speaker fees from ViiV, Merck, and GlaxoSmithKline. Dr. Vasylyev reported no relevant financial relationships.  

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

One year into offering the first long-acting injectable HIV treatment to his patients, Jonathan Angel, MD, head of the division of infectious diseases at the University of Ottawa, reported that 15 of the 21 of patients who started on the regimen are still taking it, all with viral suppression. Those who weren’t cited a combination of inconvenience, injection site pain, and “injection fatigue.”

These are just a few things HIV providers are learning as they begin what Chloe Orkin, MD, professor of HIV medicine at Queen Mary University of London, called a paradigm shift to long-acting treatment, which may soon include not just shots but rings, implants, and microarray patches.

“It’s a paradigm shift, and we are at the very beginning of this paradigm shift,” said Dr. Orkin, commenting during the discussion session of the European AIDS Clinical Society 2021 annual meeting. “We’re having to change our model, and it’s challenging.”

In the United States, the Food and Drug Administration approved the first long-acting injectable, a combination of cabotegravir and rilpivirine (CAB/RIL; Cabenuva, ViiV Healthcare) in January 2021. But it has been approved in Canada since March 2020 and available at Dr. Angel’s clinic since November 2020. It’s also available in Canada as an every-other-month shot. Injected into the buttocks, the shot was found to be noninferior to standard daily oral treatment in many studies, including the ATLAS, the ATLAS-2M – which tested the every-other-month approach – and FLAIR trials.

Dr. Angel’s clinic was part of all three of those trials, so his clinic has had 5 years’ experience preparing for the change in workflow and the new approach the shots require.

Of the 21 people Dr. Angel has treated, 11 were white Canadians, nine were Black African, and one was Indigenous Canadian, with women making up a third of the participants. Median age was 51 years, and all patients had had undetectable viral loads before beginning the regimen. (Studies of the drug’s effectiveness in people who struggle to take daily pills are still ongoing.)

Most of those 21 patients had had undetectable viral loads for more than 5 years, but a few had been undetectable for only 6 months before beginning the shots. Their immune systems were also healthy, with a median CD4 count of 618 cells/mcL. As in the clinical trials, none of the participants had experienced antiretroviral treatment failure. Because public health insurers in Canada have yet to approve the shots, Dr. Angel’s patients receiving Cabenuva also have private health insurance. Up to 90% of people in Canada receive pharmaceutical coverage through public insurance; therefore, the shot is not yet widely available.

Twenty patients switched from integrase-inhibitor regimens, and one had been receiving a nonnucleoside reverse transcriptase inhibitor–based regimen before starting Cabenuva.

And although the drug has not been approved for shot initiation this way, two patients requested – and Dr. Angel agreed – to start them on the shots without first doing a month of daily pills to check for safety.

“This is my conclusion from these data: the oral lead-in period is not necessary,” Dr. Angel said in his presentation at the meeting. “It can provide some comfort to either a physician or a patient, but it does not seem to be medically necessary.”

That approach is not without data to back it up. Research presented at HIV Glasgow 2020 showed that people who switched from daily oral dolutegravir/abacavir/lamivudine straight to the injections did so without problems.

At last clinic visit, 15 of those 21 were still receiving the shots. None have experienced treatment failure, and all were still virally suppressed. Four participants left the trials and one more person opted to return to daily pills, citing some level of what Dr. Angel called “injection fatigue.”

“Just as we use the term ‘pill fatigue’ for patients who are tired of taking pills, patients do get tired of coming in monthly for their visits and injections,” he said. They find the trip to the clinic for the intramuscular injections “inconvenient,” he said.

Unlike in the United States, where Cabenuva is approved for only monthly injections, Health Canada has already approved the shot for every-other-month injections, which Dr. Angel said may reduce the odds of injection fatigue.

Dr. Angel’s presentation drew comments, questions, and excitement from the crowd. Annemarie Wensing, MD, assistant professor of medicine at University Medical Center Utrecht (the Netherlands), asked whether dispensing with the oral lead-in period could mean that these shots could be useful for people going on longer trips, people having surgeries where they can’t swallow pills, or in other scenarios.

“These are not hypothetical conversations,” Dr. Angel said. “I’m having these conversations with patients now – temporary use, they travel for 3 months and come back, can they go from injectable to oral to injectable.”

For now, he said, the answer is, “We’ll figure it out.”

Meanwhile, there’s another big question when it comes to injectables, said Marta Vas ylyev, MD, from Lviv (Ukraine) Regional AIDS Center: When will they be available to the people who might benefit most from them – people in resource-limited settings, people who so far have struggled to remember to take their pills every day?

For now, Dr. Angel replied, injectables continue to be a treatment only for those who are already doing well while receiving HIV treatment: those with already suppressed viral load, who are good at taking daily pills, and who are being treated at well-resourced clinics.

“There are huge obstacles to overcome if this is ever to be available [in resource-limited settings], and way more obstacles than there are with any oral therapies,” he said. “There’s not been much discussion here about the necessity of cold-chain requirements of pharmacies either centrally or locally, [or] the requirements of additional nurses or health care staff to administer the medication. So you’re looking at a very resource-intensive therapy, which now is fairly restrictive [as to] who will have access to it.”

Dr. Angel reports serving on advisory boards for ViiV Healthcare and Gilead Sciences and has done contract research for ViiV Healthcare, Gilead, and Merck. Dr. Orkin has received research grants, fees as a consultant, travel sponsorship, and speaker fees from ViiV, Merck, and GlaxoSmithKline. Dr. Vasylyev reported no relevant financial relationships.  

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