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STI & AIDS World Congress 2013: Joint Meeting of the 20th ISSTDR and 14th IUSTI
M. genitalium demands new STI treatment strategy
VIENNA – Mycoplasma genitalium is a new bad boy of sexually transmitted infections, prompting experts to rethink how to treat nongonococcal urethritis, pelvic inflammatory disease, and other infections caused by the pathogen.
The full scope of M. genitalium in sexually transmitted infections (STI) of men and women is just now becoming clear – as are the treatment demands of M. genitalium’s susceptibility profile. Given that it’s notoriously hard to culture and that genetic-based assays are only recently available and not yet sold commercially, reliable management of M. genitalium depends on the fluoroquinolone moxifloxacin. Yet the threat of widespread resistance to that drug looms, with no good back-up agents currently available.
Because successful treatment of M. genitalium differs sharply from that of gonorrhea and Chlamydia trachomatis – the other two pathogens most common in urethritis, cervicitis, and pelvic inflammatory disease – clinicians increasingly confront infections unresponsive to or persistent despite a course of doxycycline or azithromycin (Zithromax).
Podium talks from a series of researchers in the United States and Europe at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections documented the STI niche that M. genitalium occupies and how well various antibiotics work against the pathogen.
"M. genitalium is associated with 15%-22% of nongonococcal urethritis cases, and 10%-15% of cervicitis cases, and in many settings is more common that Neisseria gonorrhoeae with treatment outcomes often far worse," said Lisa E. Manhart, Ph.D., an epidemiologist at the University of Washington, Seattle. "There is no characteristic clinical syndrome for M. genitalium infections; they look very similar to Chlamydia. Clinical judgment is the only option for treatment decisions in many settings, and no FDA-approved diagnostic test [for M. genitalium] exists."
Persistent cases of nongonococcal urethritis, cervicitis, and possibly pelvic inflammatory disease could benefit from treatment with moxifloxacin (Avelox), Dr. Manhart noted. But "it is becoming clear that resistance in M. genitalium develops rapidly."
"M. genitalium is an important STI, and guidelines should reflect this; but there is no good evidence base for optimal treatment. Optimal treatment is a moving target," said Dr. Jørgen S. Jensen, a researcher at the Statens Serum Institut in Copenhagen.
"Widespread use of azithromycin and moxifloxacin will select for multidrug-resistant strains; the time for single-drug, one-dose regimens is probably over," said Dr. Jensen, specifically referring to the common practice of treating nongonococcal urethritis with a single dose of azithromycin.
M. genitalium invades U.S.
Dr. Manhart and a second U.S. researcher, Dr. Harold C. Wiesenfeld from the University of Pittsburgh, each reported new data at the meeting showing how common M. genitalium STI infections have become among U.S. patients.
Dr. Manhart presented new data from the MEGA (Mycoplasma Genitalium Antibiotic Susceptibility and Treatment) trial, which enrolled 606 men with nongonococcal urethritis (NGU) at an STI clinic in Seattle. The study’s primary endpoint was a comparison of 100 mg doxycycline b.i.d. for 7 days and a single 1-g dose of azithromycin.
The two regimens produced similar cure rates – 76% in the doxycycline arm, and 80% in the azithromycin arm, Dr. Manhart and her associates reported earlier this year (Clin. Infec. Dis. 2013;56:934-42). The initial report also identified M. genitalium in 13% of those men – identified using an in-house polymerase chain reaction assay – compared with 24% who tested positive for Chlamydia and 23% infected with Ureaplasma urealyticum biovar.
The new analyses Dr. Manhart reported tracked the outcomes of patients infected with M. genitalium. Treatment with either of the standard doxycycline or azithromycin regimens failed about half the time, Dr. Manhart said: 29% of men with doxycycline-resistant infections who were retreated with azithromycin as part of the study’s extended protocol carried M. genitalium, and 70% of the men who failed initial azithromycin treatment who were then retreated with doxycycline had persistent infection with M. genitalium.
Results from the extended portion of the study also showed that treatment with moxifloxacin was the answer for most of the otherwise unresponsive M. genitalium infections, but it wasn’t perfect. The M. genitalium infection persisted in 12%-15% of those men after a full course of moxifloxacin.
The full results suggest that moxifloxacin is potentially effective for treating various persistent STIs, not only NGU but also cervicitis and possibly pelvic inflammatory disease (PID). But resistance to moxifloxacin develops "rapidly," meaning that surveillance for resistance is needed, as well as new drug alternatives, she said.
New suspect in acute PID?
Although Dr. Manhart hedged on the role of M. genitalium in PID, results from a different U.S. study created a strong case for a role in acute PID.
M. genitalium appeared in 28 (18%) of 157 diagnosed women with acute PID who were enrolled in a study that had primarily focused on comparing two antibiotic regimens, and in 30% of those women with histologically proven acute PID. Using an in-house transcription-mediated assay for M. genitalium, researchers at the University of Pittsburgh found that endometrial identification of M. genitalium linked independently with a fourfold increased prevalence of histologically confirmed acute PID.
Those numbers for M. genitalium put it in the same ball park in the study with the two traditional heavy hitters of acute PID, N. gonorrhoeae and C. trachomatis. By establishing a significant role for M. genitalium in acute PID, the data immediately called into question the standard empiric therapies for acute PID.
"The PID treatments we use fall short for eradicating M. genitalium," said Dr. Wiesenfeld, an ob.gyn. and infectious diseases physician at the University of Pittsburgh, who reported the results. "Whether these findings [affect] treatment guidelines for acute PID remains to be seen; but if it is truly important to treat M. genitalium, it will completely turn around our treatment regimens."
The looming dilemma is that the azithromycin or doxycycline used for gonorrhea will not stop many of the infections by M. genitalium, while the moxifloxacin that can handle most M. genitalium today does not eradicate N. gonorrhoeae.
However, it’s premature to consider routinely testing or screening for M. genitalium in patients with PID or other possible forms of M. genitalium infection, Dr. Wiesenfeld cautioned. That’s in part because of the current logistical limitations on testing, and in part because the long-term impact of M. genitalium infection on reproductive health is not yet established. Longer follow-up of women in the study should shed more light on the natural history of the patients who received treatments that did not eradicate M. genitalium.
"If M. genitalium turns out to be associated with PID, it is the single organism that is not covered by current treatment with a cephalosporin, doxycycline, and metronidazole," said Sharon L. Hillier, Ph. D., in an interview during the meeting. "We are very concerned about it because it is a fairly sizable fraction of the STIs we’ve seen in these women with acute PID," said Dr. Hillier, professor of ob.gyn. and reproductive sciences at the University of Pittsburgh and a collaborator with Dr. Wiesenfeld on his study.
Dr. Hillier agreed that the key question to address is the fertility risk to women from having PID caused by M. genitalium.
"It’s so common that it might have a huge population impact," she said. "We know fertility outcomes are bad from gonorrhea and Chlamydia." The fertility risk from M. genitalium "will be what makes us decide if we need to add another treatment."
Adding moxifloxacin to routine, empiric treatment for acute PID would be an especially tough call if it also meant dropping doxycycline, a drug that is otherwise attractive because of its low cost and broad spectrum of activity against other PID pathogens.
"It remains to be seen what we should do for empiric therapy for women who walk in with PID, what is the best way to try to preserve her fertility," Dr. Hillier said. "We simply don’t know right now, but it’s been a huge topic of conversation."
Changing the treatment strategies
While the best initial management strategy for acute PID remains unclear, the specter of M. genitalium has already changed the management strategy used by Dr. Paddy Horner to treat men with NGU, said Dr. Horner, a physician in the school of social and community medicine at the University of Bristol, U.K.
These days, his preferred approach is what he calls "infection-specific" first-line therapy: Before treatment begins, he eliminates purely empiric therapy by employing a commercially available, nucleic-acid amplification test for gonorrhea and Chlamydia at the first encounter and getting the result in 30 minutes.
That means treating men who test positive for Chlamydia with a week of doxycycline first, or starting with a 5-day course of azithromycin for men who are Chlamydia negative. However, he advised using a single, 1-g dosage of azithromycin with caution, because of the prevalence of macrolide resistance. But Dr. Horner also admitted that no evidence has proven the superiority of the 5-day alternative that starts with a 1-g dose followed by 500 mg daily for 4 more days. Men who test positive for N. gonorrhoeae should receive 1 g of azithromycin plus 500 mg ceftriaxone.
If the urethritis persists 2 weeks later, Dr. Horner recommended treating patients empirically with a combination of moxifloxacin and metronidazole to cover possible infection by either M. genitalium or U. urealyticum.
In theory, this overall approach has the potential to resolve 89% of infections after the first round of treatment and 99% after the second round, with low potential for generating resistant strains of M. genitalium, based on pathogen prevalence and susceptibility profiles that Dr. Horner sees in Bristol. Those outcomes are an improvement on the cure rates and resistance risks when initial treatment is applied completely empirically, he explained.
Infection-specific treatment would work even better once rapid, point-of-care genetic tests become available for M. genitalium and U. urealyticum, Dr. Horner said.
Dr. Manhart, Dr. Wiesenfeld, and Dr. Hillier had no disclosures. Dr. Jensen said that his institution provides diagnostic testing for M. genitalium commercially and also evaluates various new antimicrobials under contract. Dr. Horner said that he has been a consultant to or received research support from Aquarius Population Health, Cepheid, Hologic, and Siemens.
On Twitter @mitchelzoler
VIENNA – Mycoplasma genitalium is a new bad boy of sexually transmitted infections, prompting experts to rethink how to treat nongonococcal urethritis, pelvic inflammatory disease, and other infections caused by the pathogen.
The full scope of M. genitalium in sexually transmitted infections (STI) of men and women is just now becoming clear – as are the treatment demands of M. genitalium’s susceptibility profile. Given that it’s notoriously hard to culture and that genetic-based assays are only recently available and not yet sold commercially, reliable management of M. genitalium depends on the fluoroquinolone moxifloxacin. Yet the threat of widespread resistance to that drug looms, with no good back-up agents currently available.
Because successful treatment of M. genitalium differs sharply from that of gonorrhea and Chlamydia trachomatis – the other two pathogens most common in urethritis, cervicitis, and pelvic inflammatory disease – clinicians increasingly confront infections unresponsive to or persistent despite a course of doxycycline or azithromycin (Zithromax).
Podium talks from a series of researchers in the United States and Europe at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections documented the STI niche that M. genitalium occupies and how well various antibiotics work against the pathogen.
"M. genitalium is associated with 15%-22% of nongonococcal urethritis cases, and 10%-15% of cervicitis cases, and in many settings is more common that Neisseria gonorrhoeae with treatment outcomes often far worse," said Lisa E. Manhart, Ph.D., an epidemiologist at the University of Washington, Seattle. "There is no characteristic clinical syndrome for M. genitalium infections; they look very similar to Chlamydia. Clinical judgment is the only option for treatment decisions in many settings, and no FDA-approved diagnostic test [for M. genitalium] exists."
Persistent cases of nongonococcal urethritis, cervicitis, and possibly pelvic inflammatory disease could benefit from treatment with moxifloxacin (Avelox), Dr. Manhart noted. But "it is becoming clear that resistance in M. genitalium develops rapidly."
"M. genitalium is an important STI, and guidelines should reflect this; but there is no good evidence base for optimal treatment. Optimal treatment is a moving target," said Dr. Jørgen S. Jensen, a researcher at the Statens Serum Institut in Copenhagen.
"Widespread use of azithromycin and moxifloxacin will select for multidrug-resistant strains; the time for single-drug, one-dose regimens is probably over," said Dr. Jensen, specifically referring to the common practice of treating nongonococcal urethritis with a single dose of azithromycin.
M. genitalium invades U.S.
Dr. Manhart and a second U.S. researcher, Dr. Harold C. Wiesenfeld from the University of Pittsburgh, each reported new data at the meeting showing how common M. genitalium STI infections have become among U.S. patients.
Dr. Manhart presented new data from the MEGA (Mycoplasma Genitalium Antibiotic Susceptibility and Treatment) trial, which enrolled 606 men with nongonococcal urethritis (NGU) at an STI clinic in Seattle. The study’s primary endpoint was a comparison of 100 mg doxycycline b.i.d. for 7 days and a single 1-g dose of azithromycin.
The two regimens produced similar cure rates – 76% in the doxycycline arm, and 80% in the azithromycin arm, Dr. Manhart and her associates reported earlier this year (Clin. Infec. Dis. 2013;56:934-42). The initial report also identified M. genitalium in 13% of those men – identified using an in-house polymerase chain reaction assay – compared with 24% who tested positive for Chlamydia and 23% infected with Ureaplasma urealyticum biovar.
The new analyses Dr. Manhart reported tracked the outcomes of patients infected with M. genitalium. Treatment with either of the standard doxycycline or azithromycin regimens failed about half the time, Dr. Manhart said: 29% of men with doxycycline-resistant infections who were retreated with azithromycin as part of the study’s extended protocol carried M. genitalium, and 70% of the men who failed initial azithromycin treatment who were then retreated with doxycycline had persistent infection with M. genitalium.
Results from the extended portion of the study also showed that treatment with moxifloxacin was the answer for most of the otherwise unresponsive M. genitalium infections, but it wasn’t perfect. The M. genitalium infection persisted in 12%-15% of those men after a full course of moxifloxacin.
The full results suggest that moxifloxacin is potentially effective for treating various persistent STIs, not only NGU but also cervicitis and possibly pelvic inflammatory disease (PID). But resistance to moxifloxacin develops "rapidly," meaning that surveillance for resistance is needed, as well as new drug alternatives, she said.
New suspect in acute PID?
Although Dr. Manhart hedged on the role of M. genitalium in PID, results from a different U.S. study created a strong case for a role in acute PID.
M. genitalium appeared in 28 (18%) of 157 diagnosed women with acute PID who were enrolled in a study that had primarily focused on comparing two antibiotic regimens, and in 30% of those women with histologically proven acute PID. Using an in-house transcription-mediated assay for M. genitalium, researchers at the University of Pittsburgh found that endometrial identification of M. genitalium linked independently with a fourfold increased prevalence of histologically confirmed acute PID.
Those numbers for M. genitalium put it in the same ball park in the study with the two traditional heavy hitters of acute PID, N. gonorrhoeae and C. trachomatis. By establishing a significant role for M. genitalium in acute PID, the data immediately called into question the standard empiric therapies for acute PID.
"The PID treatments we use fall short for eradicating M. genitalium," said Dr. Wiesenfeld, an ob.gyn. and infectious diseases physician at the University of Pittsburgh, who reported the results. "Whether these findings [affect] treatment guidelines for acute PID remains to be seen; but if it is truly important to treat M. genitalium, it will completely turn around our treatment regimens."
The looming dilemma is that the azithromycin or doxycycline used for gonorrhea will not stop many of the infections by M. genitalium, while the moxifloxacin that can handle most M. genitalium today does not eradicate N. gonorrhoeae.
However, it’s premature to consider routinely testing or screening for M. genitalium in patients with PID or other possible forms of M. genitalium infection, Dr. Wiesenfeld cautioned. That’s in part because of the current logistical limitations on testing, and in part because the long-term impact of M. genitalium infection on reproductive health is not yet established. Longer follow-up of women in the study should shed more light on the natural history of the patients who received treatments that did not eradicate M. genitalium.
"If M. genitalium turns out to be associated with PID, it is the single organism that is not covered by current treatment with a cephalosporin, doxycycline, and metronidazole," said Sharon L. Hillier, Ph. D., in an interview during the meeting. "We are very concerned about it because it is a fairly sizable fraction of the STIs we’ve seen in these women with acute PID," said Dr. Hillier, professor of ob.gyn. and reproductive sciences at the University of Pittsburgh and a collaborator with Dr. Wiesenfeld on his study.
Dr. Hillier agreed that the key question to address is the fertility risk to women from having PID caused by M. genitalium.
"It’s so common that it might have a huge population impact," she said. "We know fertility outcomes are bad from gonorrhea and Chlamydia." The fertility risk from M. genitalium "will be what makes us decide if we need to add another treatment."
Adding moxifloxacin to routine, empiric treatment for acute PID would be an especially tough call if it also meant dropping doxycycline, a drug that is otherwise attractive because of its low cost and broad spectrum of activity against other PID pathogens.
"It remains to be seen what we should do for empiric therapy for women who walk in with PID, what is the best way to try to preserve her fertility," Dr. Hillier said. "We simply don’t know right now, but it’s been a huge topic of conversation."
Changing the treatment strategies
While the best initial management strategy for acute PID remains unclear, the specter of M. genitalium has already changed the management strategy used by Dr. Paddy Horner to treat men with NGU, said Dr. Horner, a physician in the school of social and community medicine at the University of Bristol, U.K.
These days, his preferred approach is what he calls "infection-specific" first-line therapy: Before treatment begins, he eliminates purely empiric therapy by employing a commercially available, nucleic-acid amplification test for gonorrhea and Chlamydia at the first encounter and getting the result in 30 minutes.
That means treating men who test positive for Chlamydia with a week of doxycycline first, or starting with a 5-day course of azithromycin for men who are Chlamydia negative. However, he advised using a single, 1-g dosage of azithromycin with caution, because of the prevalence of macrolide resistance. But Dr. Horner also admitted that no evidence has proven the superiority of the 5-day alternative that starts with a 1-g dose followed by 500 mg daily for 4 more days. Men who test positive for N. gonorrhoeae should receive 1 g of azithromycin plus 500 mg ceftriaxone.
If the urethritis persists 2 weeks later, Dr. Horner recommended treating patients empirically with a combination of moxifloxacin and metronidazole to cover possible infection by either M. genitalium or U. urealyticum.
In theory, this overall approach has the potential to resolve 89% of infections after the first round of treatment and 99% after the second round, with low potential for generating resistant strains of M. genitalium, based on pathogen prevalence and susceptibility profiles that Dr. Horner sees in Bristol. Those outcomes are an improvement on the cure rates and resistance risks when initial treatment is applied completely empirically, he explained.
Infection-specific treatment would work even better once rapid, point-of-care genetic tests become available for M. genitalium and U. urealyticum, Dr. Horner said.
Dr. Manhart, Dr. Wiesenfeld, and Dr. Hillier had no disclosures. Dr. Jensen said that his institution provides diagnostic testing for M. genitalium commercially and also evaluates various new antimicrobials under contract. Dr. Horner said that he has been a consultant to or received research support from Aquarius Population Health, Cepheid, Hologic, and Siemens.
On Twitter @mitchelzoler
VIENNA – Mycoplasma genitalium is a new bad boy of sexually transmitted infections, prompting experts to rethink how to treat nongonococcal urethritis, pelvic inflammatory disease, and other infections caused by the pathogen.
The full scope of M. genitalium in sexually transmitted infections (STI) of men and women is just now becoming clear – as are the treatment demands of M. genitalium’s susceptibility profile. Given that it’s notoriously hard to culture and that genetic-based assays are only recently available and not yet sold commercially, reliable management of M. genitalium depends on the fluoroquinolone moxifloxacin. Yet the threat of widespread resistance to that drug looms, with no good back-up agents currently available.
Because successful treatment of M. genitalium differs sharply from that of gonorrhea and Chlamydia trachomatis – the other two pathogens most common in urethritis, cervicitis, and pelvic inflammatory disease – clinicians increasingly confront infections unresponsive to or persistent despite a course of doxycycline or azithromycin (Zithromax).
Podium talks from a series of researchers in the United States and Europe at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections documented the STI niche that M. genitalium occupies and how well various antibiotics work against the pathogen.
"M. genitalium is associated with 15%-22% of nongonococcal urethritis cases, and 10%-15% of cervicitis cases, and in many settings is more common that Neisseria gonorrhoeae with treatment outcomes often far worse," said Lisa E. Manhart, Ph.D., an epidemiologist at the University of Washington, Seattle. "There is no characteristic clinical syndrome for M. genitalium infections; they look very similar to Chlamydia. Clinical judgment is the only option for treatment decisions in many settings, and no FDA-approved diagnostic test [for M. genitalium] exists."
Persistent cases of nongonococcal urethritis, cervicitis, and possibly pelvic inflammatory disease could benefit from treatment with moxifloxacin (Avelox), Dr. Manhart noted. But "it is becoming clear that resistance in M. genitalium develops rapidly."
"M. genitalium is an important STI, and guidelines should reflect this; but there is no good evidence base for optimal treatment. Optimal treatment is a moving target," said Dr. Jørgen S. Jensen, a researcher at the Statens Serum Institut in Copenhagen.
"Widespread use of azithromycin and moxifloxacin will select for multidrug-resistant strains; the time for single-drug, one-dose regimens is probably over," said Dr. Jensen, specifically referring to the common practice of treating nongonococcal urethritis with a single dose of azithromycin.
M. genitalium invades U.S.
Dr. Manhart and a second U.S. researcher, Dr. Harold C. Wiesenfeld from the University of Pittsburgh, each reported new data at the meeting showing how common M. genitalium STI infections have become among U.S. patients.
Dr. Manhart presented new data from the MEGA (Mycoplasma Genitalium Antibiotic Susceptibility and Treatment) trial, which enrolled 606 men with nongonococcal urethritis (NGU) at an STI clinic in Seattle. The study’s primary endpoint was a comparison of 100 mg doxycycline b.i.d. for 7 days and a single 1-g dose of azithromycin.
The two regimens produced similar cure rates – 76% in the doxycycline arm, and 80% in the azithromycin arm, Dr. Manhart and her associates reported earlier this year (Clin. Infec. Dis. 2013;56:934-42). The initial report also identified M. genitalium in 13% of those men – identified using an in-house polymerase chain reaction assay – compared with 24% who tested positive for Chlamydia and 23% infected with Ureaplasma urealyticum biovar.
The new analyses Dr. Manhart reported tracked the outcomes of patients infected with M. genitalium. Treatment with either of the standard doxycycline or azithromycin regimens failed about half the time, Dr. Manhart said: 29% of men with doxycycline-resistant infections who were retreated with azithromycin as part of the study’s extended protocol carried M. genitalium, and 70% of the men who failed initial azithromycin treatment who were then retreated with doxycycline had persistent infection with M. genitalium.
Results from the extended portion of the study also showed that treatment with moxifloxacin was the answer for most of the otherwise unresponsive M. genitalium infections, but it wasn’t perfect. The M. genitalium infection persisted in 12%-15% of those men after a full course of moxifloxacin.
The full results suggest that moxifloxacin is potentially effective for treating various persistent STIs, not only NGU but also cervicitis and possibly pelvic inflammatory disease (PID). But resistance to moxifloxacin develops "rapidly," meaning that surveillance for resistance is needed, as well as new drug alternatives, she said.
New suspect in acute PID?
Although Dr. Manhart hedged on the role of M. genitalium in PID, results from a different U.S. study created a strong case for a role in acute PID.
M. genitalium appeared in 28 (18%) of 157 diagnosed women with acute PID who were enrolled in a study that had primarily focused on comparing two antibiotic regimens, and in 30% of those women with histologically proven acute PID. Using an in-house transcription-mediated assay for M. genitalium, researchers at the University of Pittsburgh found that endometrial identification of M. genitalium linked independently with a fourfold increased prevalence of histologically confirmed acute PID.
Those numbers for M. genitalium put it in the same ball park in the study with the two traditional heavy hitters of acute PID, N. gonorrhoeae and C. trachomatis. By establishing a significant role for M. genitalium in acute PID, the data immediately called into question the standard empiric therapies for acute PID.
"The PID treatments we use fall short for eradicating M. genitalium," said Dr. Wiesenfeld, an ob.gyn. and infectious diseases physician at the University of Pittsburgh, who reported the results. "Whether these findings [affect] treatment guidelines for acute PID remains to be seen; but if it is truly important to treat M. genitalium, it will completely turn around our treatment regimens."
The looming dilemma is that the azithromycin or doxycycline used for gonorrhea will not stop many of the infections by M. genitalium, while the moxifloxacin that can handle most M. genitalium today does not eradicate N. gonorrhoeae.
However, it’s premature to consider routinely testing or screening for M. genitalium in patients with PID or other possible forms of M. genitalium infection, Dr. Wiesenfeld cautioned. That’s in part because of the current logistical limitations on testing, and in part because the long-term impact of M. genitalium infection on reproductive health is not yet established. Longer follow-up of women in the study should shed more light on the natural history of the patients who received treatments that did not eradicate M. genitalium.
"If M. genitalium turns out to be associated with PID, it is the single organism that is not covered by current treatment with a cephalosporin, doxycycline, and metronidazole," said Sharon L. Hillier, Ph. D., in an interview during the meeting. "We are very concerned about it because it is a fairly sizable fraction of the STIs we’ve seen in these women with acute PID," said Dr. Hillier, professor of ob.gyn. and reproductive sciences at the University of Pittsburgh and a collaborator with Dr. Wiesenfeld on his study.
Dr. Hillier agreed that the key question to address is the fertility risk to women from having PID caused by M. genitalium.
"It’s so common that it might have a huge population impact," she said. "We know fertility outcomes are bad from gonorrhea and Chlamydia." The fertility risk from M. genitalium "will be what makes us decide if we need to add another treatment."
Adding moxifloxacin to routine, empiric treatment for acute PID would be an especially tough call if it also meant dropping doxycycline, a drug that is otherwise attractive because of its low cost and broad spectrum of activity against other PID pathogens.
"It remains to be seen what we should do for empiric therapy for women who walk in with PID, what is the best way to try to preserve her fertility," Dr. Hillier said. "We simply don’t know right now, but it’s been a huge topic of conversation."
Changing the treatment strategies
While the best initial management strategy for acute PID remains unclear, the specter of M. genitalium has already changed the management strategy used by Dr. Paddy Horner to treat men with NGU, said Dr. Horner, a physician in the school of social and community medicine at the University of Bristol, U.K.
These days, his preferred approach is what he calls "infection-specific" first-line therapy: Before treatment begins, he eliminates purely empiric therapy by employing a commercially available, nucleic-acid amplification test for gonorrhea and Chlamydia at the first encounter and getting the result in 30 minutes.
That means treating men who test positive for Chlamydia with a week of doxycycline first, or starting with a 5-day course of azithromycin for men who are Chlamydia negative. However, he advised using a single, 1-g dosage of azithromycin with caution, because of the prevalence of macrolide resistance. But Dr. Horner also admitted that no evidence has proven the superiority of the 5-day alternative that starts with a 1-g dose followed by 500 mg daily for 4 more days. Men who test positive for N. gonorrhoeae should receive 1 g of azithromycin plus 500 mg ceftriaxone.
If the urethritis persists 2 weeks later, Dr. Horner recommended treating patients empirically with a combination of moxifloxacin and metronidazole to cover possible infection by either M. genitalium or U. urealyticum.
In theory, this overall approach has the potential to resolve 89% of infections after the first round of treatment and 99% after the second round, with low potential for generating resistant strains of M. genitalium, based on pathogen prevalence and susceptibility profiles that Dr. Horner sees in Bristol. Those outcomes are an improvement on the cure rates and resistance risks when initial treatment is applied completely empirically, he explained.
Infection-specific treatment would work even better once rapid, point-of-care genetic tests become available for M. genitalium and U. urealyticum, Dr. Horner said.
Dr. Manhart, Dr. Wiesenfeld, and Dr. Hillier had no disclosures. Dr. Jensen said that his institution provides diagnostic testing for M. genitalium commercially and also evaluates various new antimicrobials under contract. Dr. Horner said that he has been a consultant to or received research support from Aquarius Population Health, Cepheid, Hologic, and Siemens.
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE STI & AIDS WORLD CONGRESS 2013
Rising gonorrhea incidence links to higher resistance
VIENNA – A rising prevalence of ciprofloxacin resistance in gonorrhea linked with an increased rate of infections in the United States during 1991-2006, based on data from 17 U.S. cities.
An increase in the prevalence of ciprofloxacin-resistant gonorrhea isolates from none to 10% linked with a statistically significant 7% rise in the incidence of gonorrhea, reported Harrell W. Chesson, Ph.D., and his associates from the Centers for Disease Control and Prevention.
"To our knowledge, this is the first study to document an association between antimicrobial resistance and increased gonorrhea incidence rates at the population level," said Dr. Chesson, a health economist in the division of STD prevention of the CDC in Atlanta. The link between increased ciprofloxacin resistance and increased gonorrhea incidence occurred even though effective treatment options for gonorrhea other than ciprofloxacin existed at the time.
These findings can help anticipate the potential impact of cephalosporin resistance in circulating gonorrhea strains in the United States, Dr. Chesson and his associates said in a poster at the congress of the International Society for STD Research.
Cephalosporin resistance in gonorrhea isolates is a growing problem, and last year it prompted the CDC to eliminate cefixime as the first-line agent for treating gonorrhea (MMWR 2012;61:590-4). The CDC designated another cephalosporin, ceftriaxone, as the current first-line agent, but it also noted that emergence of gonococcal resistance to ceftriaxone was probably inevitable.
"Emerging cephalosporin resistance could have even more substantial health and economic consequences [than did ciprofloxacin resistance], particularly as the number of available treatment options decreases," Dr. Chesson and his associates said.
Although they cautioned that the evidence they found cannot establish ciprofloxacin resistance in gonorrhea as the cause of the increased incidence, their findings "offer evidence consistent with that of a causal association between resistance and increased incidence."
If 10% of circulating gonorrhea strains remained resistant to a widely used antibiotic, Dr. Chesson and his associates projected, the consequent rise in infection incidence would lead to 50,000 additional cases of pelvic inflammatory disease over a 10-year period and an additional 5,400 cases of epididymitis, compared with rates if resistance did not exist.
To perform the analysis, the researchers used data on gonorrhea resistance that were collected in the Gonococcal Isolate Surveillance Project of the CDC and coupled these data with incidence rates from routine surveillance done in 17 U.S. cities during 1991-2006. In their regression analysis they controlled for socio-demographic factors, city-specific factors, and national trends during the 16-year period.
Disease transmission models suggest that antimicrobial resistance may increase gonorrhea incidence by prolonging the average duration of a patient’s infection, but the authors cautioned that several other factors aside from antibiotic resistance also affect gonorrhea incidence rates.
Dr. Chesson had no disclosures.
On Twitter @mitchelzoler
VIENNA – A rising prevalence of ciprofloxacin resistance in gonorrhea linked with an increased rate of infections in the United States during 1991-2006, based on data from 17 U.S. cities.
An increase in the prevalence of ciprofloxacin-resistant gonorrhea isolates from none to 10% linked with a statistically significant 7% rise in the incidence of gonorrhea, reported Harrell W. Chesson, Ph.D., and his associates from the Centers for Disease Control and Prevention.
"To our knowledge, this is the first study to document an association between antimicrobial resistance and increased gonorrhea incidence rates at the population level," said Dr. Chesson, a health economist in the division of STD prevention of the CDC in Atlanta. The link between increased ciprofloxacin resistance and increased gonorrhea incidence occurred even though effective treatment options for gonorrhea other than ciprofloxacin existed at the time.
These findings can help anticipate the potential impact of cephalosporin resistance in circulating gonorrhea strains in the United States, Dr. Chesson and his associates said in a poster at the congress of the International Society for STD Research.
Cephalosporin resistance in gonorrhea isolates is a growing problem, and last year it prompted the CDC to eliminate cefixime as the first-line agent for treating gonorrhea (MMWR 2012;61:590-4). The CDC designated another cephalosporin, ceftriaxone, as the current first-line agent, but it also noted that emergence of gonococcal resistance to ceftriaxone was probably inevitable.
"Emerging cephalosporin resistance could have even more substantial health and economic consequences [than did ciprofloxacin resistance], particularly as the number of available treatment options decreases," Dr. Chesson and his associates said.
Although they cautioned that the evidence they found cannot establish ciprofloxacin resistance in gonorrhea as the cause of the increased incidence, their findings "offer evidence consistent with that of a causal association between resistance and increased incidence."
If 10% of circulating gonorrhea strains remained resistant to a widely used antibiotic, Dr. Chesson and his associates projected, the consequent rise in infection incidence would lead to 50,000 additional cases of pelvic inflammatory disease over a 10-year period and an additional 5,400 cases of epididymitis, compared with rates if resistance did not exist.
To perform the analysis, the researchers used data on gonorrhea resistance that were collected in the Gonococcal Isolate Surveillance Project of the CDC and coupled these data with incidence rates from routine surveillance done in 17 U.S. cities during 1991-2006. In their regression analysis they controlled for socio-demographic factors, city-specific factors, and national trends during the 16-year period.
Disease transmission models suggest that antimicrobial resistance may increase gonorrhea incidence by prolonging the average duration of a patient’s infection, but the authors cautioned that several other factors aside from antibiotic resistance also affect gonorrhea incidence rates.
Dr. Chesson had no disclosures.
On Twitter @mitchelzoler
VIENNA – A rising prevalence of ciprofloxacin resistance in gonorrhea linked with an increased rate of infections in the United States during 1991-2006, based on data from 17 U.S. cities.
An increase in the prevalence of ciprofloxacin-resistant gonorrhea isolates from none to 10% linked with a statistically significant 7% rise in the incidence of gonorrhea, reported Harrell W. Chesson, Ph.D., and his associates from the Centers for Disease Control and Prevention.
"To our knowledge, this is the first study to document an association between antimicrobial resistance and increased gonorrhea incidence rates at the population level," said Dr. Chesson, a health economist in the division of STD prevention of the CDC in Atlanta. The link between increased ciprofloxacin resistance and increased gonorrhea incidence occurred even though effective treatment options for gonorrhea other than ciprofloxacin existed at the time.
These findings can help anticipate the potential impact of cephalosporin resistance in circulating gonorrhea strains in the United States, Dr. Chesson and his associates said in a poster at the congress of the International Society for STD Research.
Cephalosporin resistance in gonorrhea isolates is a growing problem, and last year it prompted the CDC to eliminate cefixime as the first-line agent for treating gonorrhea (MMWR 2012;61:590-4). The CDC designated another cephalosporin, ceftriaxone, as the current first-line agent, but it also noted that emergence of gonococcal resistance to ceftriaxone was probably inevitable.
"Emerging cephalosporin resistance could have even more substantial health and economic consequences [than did ciprofloxacin resistance], particularly as the number of available treatment options decreases," Dr. Chesson and his associates said.
Although they cautioned that the evidence they found cannot establish ciprofloxacin resistance in gonorrhea as the cause of the increased incidence, their findings "offer evidence consistent with that of a causal association between resistance and increased incidence."
If 10% of circulating gonorrhea strains remained resistant to a widely used antibiotic, Dr. Chesson and his associates projected, the consequent rise in infection incidence would lead to 50,000 additional cases of pelvic inflammatory disease over a 10-year period and an additional 5,400 cases of epididymitis, compared with rates if resistance did not exist.
To perform the analysis, the researchers used data on gonorrhea resistance that were collected in the Gonococcal Isolate Surveillance Project of the CDC and coupled these data with incidence rates from routine surveillance done in 17 U.S. cities during 1991-2006. In their regression analysis they controlled for socio-demographic factors, city-specific factors, and national trends during the 16-year period.
Disease transmission models suggest that antimicrobial resistance may increase gonorrhea incidence by prolonging the average duration of a patient’s infection, but the authors cautioned that several other factors aside from antibiotic resistance also affect gonorrhea incidence rates.
Dr. Chesson had no disclosures.
On Twitter @mitchelzoler
AT THE STI & AIDS CONGRESS 2013
Major finding: As ciprofloxacin resistance in U.S. gonorrhea isolates rose from 0 to 10%, gonorrhea incidence rose by 7%.
Data source: CDC analysis of gonorrhea resistance and incidence data in 17 U.S. cities during 1991-2006.
Disclosures: Dr. Chesson had no disclosures.
Awash in infectious-disease cascades
Prevention and treatment cascades are the new way to make sense of epidemics and how they might be better controlled.
Cascade analyses have, for example, shown that the biggest public health issue for controlling some common and challenging sexually transmitted infections (STIs), such as Chlamydia trachomatis and gonorrhea, is identifying infected people who are asymptomatic, said STI expert Dr. King K. Holmes, of the University of Washington, Seattle.
"Enormous attention is being given to prevention and treatment cascades" right now, Dr. Holmes said at the STI & AIDS World Congress 2013 in Vienna. This trend only began a couple of years ago.
Though occasional iterations of the cascade concept go back to at least 1969, the concept went high profile in 2011 with an analysis (Clin. Inf. Dis. 2011:52:793-800) of HIV diagnosis and treatment by a team of U.S. epidemiologists led by Dr. Edward M. Gardner, of the Denver Department of Public Health and the University of Colorado Denver, Aurora. Although the 2011 report never even used the word cascade, it spelled out the linked sequence of events required to successfully treat HIV-infected patients: diagnosis, getting patients to places where HIV management occurs, and finishing with treatment and adherence.
Even before Dr. Holmes cited the Gardner paper in his talk a few weeks ago, other experts recognized how groundbreaking and important the Gardner thesis was. Blogging a year ago, Dr. Ronald Valdiserri, director of the U.S. Office of HIV/AIDS and Infectious Disease Policy, wrote, "The HIV/AIDS treatment cascade provides a way to examine critical questions including: How many individuals living with HIV are getting tested and diagnosed? Of those, how many are linked to medical care? Of those, how many are retained in care? Of those, how many receive antiretroviral therapy? Of those, how many are able to adhere to their treatment plan and achieve viral suppression?"
By a year ago, "at the Federal level government agencies used the treatment cascade to inform discussions about how best to prioritize and target resources," Dr. Valdiserri wrote.
Infectious disease groups that recently applied prevention and treatment cascades to their favorite diseases include the GAVI Campaign for childhood immunization, Roll Back Malaria the Stop TB Partnership, and the Integrated Management of Childhood Illness (IMCI) initiative of the World Health Organization, said Dr. Holmes.
He then challenged every person at his talk by asking the audience, "How are you using cascade models in your work?"
He also presented an example of cascade analysis applied to his own study, Peru PREVEN, which last year showed no effect from four interventions designed to cut STI incidence in Peru (Lancet 2012;379:1120-8). This controlled study randomized 10 cities that tried the interventions and 10 cities that continued with standard practice. The study’s primary result showed no significant change in infection rates linked to the interventions. But the cascade analysis identified the major choke point for improving outcomes with intervention: identifying patients with an STI who lack symptoms. For example, in the Peru PREVEN study, 3% of the nearly 6,400 men in the study had chlamydial infections, but only 9% of infected men had symptoms. Even though nearly half of the symptomatic men sought treatment, the absolute number of infected men seeking treatment was minuscule because more than 90% were symptom free. Cascade analysis identified why the Peru PREVEN interventions failed to produce a statistically significant difference in outcomes.
Of course, the next step will not be easy: coming up with good, new ways to identify asymptomatic people to eradicate more infections and stop their spread.
–Mitchel L. Zoler
On Twitter @mitchelzoler
Prevention and treatment cascades are the new way to make sense of epidemics and how they might be better controlled.
Cascade analyses have, for example, shown that the biggest public health issue for controlling some common and challenging sexually transmitted infections (STIs), such as Chlamydia trachomatis and gonorrhea, is identifying infected people who are asymptomatic, said STI expert Dr. King K. Holmes, of the University of Washington, Seattle.
"Enormous attention is being given to prevention and treatment cascades" right now, Dr. Holmes said at the STI & AIDS World Congress 2013 in Vienna. This trend only began a couple of years ago.
Though occasional iterations of the cascade concept go back to at least 1969, the concept went high profile in 2011 with an analysis (Clin. Inf. Dis. 2011:52:793-800) of HIV diagnosis and treatment by a team of U.S. epidemiologists led by Dr. Edward M. Gardner, of the Denver Department of Public Health and the University of Colorado Denver, Aurora. Although the 2011 report never even used the word cascade, it spelled out the linked sequence of events required to successfully treat HIV-infected patients: diagnosis, getting patients to places where HIV management occurs, and finishing with treatment and adherence.
Even before Dr. Holmes cited the Gardner paper in his talk a few weeks ago, other experts recognized how groundbreaking and important the Gardner thesis was. Blogging a year ago, Dr. Ronald Valdiserri, director of the U.S. Office of HIV/AIDS and Infectious Disease Policy, wrote, "The HIV/AIDS treatment cascade provides a way to examine critical questions including: How many individuals living with HIV are getting tested and diagnosed? Of those, how many are linked to medical care? Of those, how many are retained in care? Of those, how many receive antiretroviral therapy? Of those, how many are able to adhere to their treatment plan and achieve viral suppression?"
By a year ago, "at the Federal level government agencies used the treatment cascade to inform discussions about how best to prioritize and target resources," Dr. Valdiserri wrote.
Infectious disease groups that recently applied prevention and treatment cascades to their favorite diseases include the GAVI Campaign for childhood immunization, Roll Back Malaria the Stop TB Partnership, and the Integrated Management of Childhood Illness (IMCI) initiative of the World Health Organization, said Dr. Holmes.
He then challenged every person at his talk by asking the audience, "How are you using cascade models in your work?"
He also presented an example of cascade analysis applied to his own study, Peru PREVEN, which last year showed no effect from four interventions designed to cut STI incidence in Peru (Lancet 2012;379:1120-8). This controlled study randomized 10 cities that tried the interventions and 10 cities that continued with standard practice. The study’s primary result showed no significant change in infection rates linked to the interventions. But the cascade analysis identified the major choke point for improving outcomes with intervention: identifying patients with an STI who lack symptoms. For example, in the Peru PREVEN study, 3% of the nearly 6,400 men in the study had chlamydial infections, but only 9% of infected men had symptoms. Even though nearly half of the symptomatic men sought treatment, the absolute number of infected men seeking treatment was minuscule because more than 90% were symptom free. Cascade analysis identified why the Peru PREVEN interventions failed to produce a statistically significant difference in outcomes.
Of course, the next step will not be easy: coming up with good, new ways to identify asymptomatic people to eradicate more infections and stop their spread.
–Mitchel L. Zoler
On Twitter @mitchelzoler
Prevention and treatment cascades are the new way to make sense of epidemics and how they might be better controlled.
Cascade analyses have, for example, shown that the biggest public health issue for controlling some common and challenging sexually transmitted infections (STIs), such as Chlamydia trachomatis and gonorrhea, is identifying infected people who are asymptomatic, said STI expert Dr. King K. Holmes, of the University of Washington, Seattle.
"Enormous attention is being given to prevention and treatment cascades" right now, Dr. Holmes said at the STI & AIDS World Congress 2013 in Vienna. This trend only began a couple of years ago.
Though occasional iterations of the cascade concept go back to at least 1969, the concept went high profile in 2011 with an analysis (Clin. Inf. Dis. 2011:52:793-800) of HIV diagnosis and treatment by a team of U.S. epidemiologists led by Dr. Edward M. Gardner, of the Denver Department of Public Health and the University of Colorado Denver, Aurora. Although the 2011 report never even used the word cascade, it spelled out the linked sequence of events required to successfully treat HIV-infected patients: diagnosis, getting patients to places where HIV management occurs, and finishing with treatment and adherence.
Even before Dr. Holmes cited the Gardner paper in his talk a few weeks ago, other experts recognized how groundbreaking and important the Gardner thesis was. Blogging a year ago, Dr. Ronald Valdiserri, director of the U.S. Office of HIV/AIDS and Infectious Disease Policy, wrote, "The HIV/AIDS treatment cascade provides a way to examine critical questions including: How many individuals living with HIV are getting tested and diagnosed? Of those, how many are linked to medical care? Of those, how many are retained in care? Of those, how many receive antiretroviral therapy? Of those, how many are able to adhere to their treatment plan and achieve viral suppression?"
By a year ago, "at the Federal level government agencies used the treatment cascade to inform discussions about how best to prioritize and target resources," Dr. Valdiserri wrote.
Infectious disease groups that recently applied prevention and treatment cascades to their favorite diseases include the GAVI Campaign for childhood immunization, Roll Back Malaria the Stop TB Partnership, and the Integrated Management of Childhood Illness (IMCI) initiative of the World Health Organization, said Dr. Holmes.
He then challenged every person at his talk by asking the audience, "How are you using cascade models in your work?"
He also presented an example of cascade analysis applied to his own study, Peru PREVEN, which last year showed no effect from four interventions designed to cut STI incidence in Peru (Lancet 2012;379:1120-8). This controlled study randomized 10 cities that tried the interventions and 10 cities that continued with standard practice. The study’s primary result showed no significant change in infection rates linked to the interventions. But the cascade analysis identified the major choke point for improving outcomes with intervention: identifying patients with an STI who lack symptoms. For example, in the Peru PREVEN study, 3% of the nearly 6,400 men in the study had chlamydial infections, but only 9% of infected men had symptoms. Even though nearly half of the symptomatic men sought treatment, the absolute number of infected men seeking treatment was minuscule because more than 90% were symptom free. Cascade analysis identified why the Peru PREVEN interventions failed to produce a statistically significant difference in outcomes.
Of course, the next step will not be easy: coming up with good, new ways to identify asymptomatic people to eradicate more infections and stop their spread.
–Mitchel L. Zoler
On Twitter @mitchelzoler
Two approved antibiotics show new gonorrhea efficacy
VIENNA – Two combination regimens using antibiotics already approved for U.S. use eradicated urogenital gonorrhea infections with virtually 100% efficacy in a multicenter U.S. study with about 400 patients, providing solid evidence for the potential of both combinations as backup treatments for Neisseria gonorrhoeae at a time when resistance in the pathogen has whittled standard treatment options down to one primary drug, ceftriaxone.
"The emergence of cephalosporin resistance complicates empiric treatment" of gonorrhea infections, Dr. Robert D. Kirkcaldy said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
The two new combinations he and his associates tested – gentamicin plus azithromycin (Zithromax) and gemifloxicin (Factive) plus azithromycin – "may be useful for patients unsuccessfully treated with ceftriaxone or patients with a cephalosporin allergy, but neither [of the two new combinations] is a magic bullet," said Dr. Kirkcaldy, a medical epidemiologist in the division of STD prevention at the Centers for Disease Control and Prevention. "The gastrointestinal side effects [seen with both new regimens] may limit their routine use."
Gastrointestinal adverse effects occurred in 47% of the patients who received gentamicin plus azithromycin and in 55% of those who got gemifloxacin plus azithromycin. But Dr. Kirkcaldy highlighted that all of these effects were mild to moderate, none was serious, and the vast majority of patients were able to hold the oral drugs they received for more than an hour; 3% of the gentamicin recipients and 8% of the gemifloxacin recipients vomited within an hour of receiving treatment and were excluded from the primary efficacy analysis as a result.
"These trial results are an exciting step in the right direction in the fight against drug-resistant gonorrhea, but patients need more oral options with fewer side effects," Dr. Gail Bolan, director of the CDC’s division of STD prevention, commented in a written statement.
Less than a year ago, in August 2012, a panel of CDC staffers and outside experts released updated recommendations for treating all types of uncomplicated gonococcal infections, including anorectal, pharyngeal, and urogenital infections. The CDC recommended a single intramuscular injection of ceftriaxone (Rocephin) along with a single oral dose of azithromycin or a 7-day course of doxycycline given b.i.d. (MMWR 2012;61:590-4).
This recommendation came about because of an increasing U.S. incidence of gonococcal infections by strains resistant to cefixime (Suprax), the prior mainstay of treatment. The need to move from cefixime to ceftriaxone also concerned the CDC. The agency projects that patients may soon also face ceftriaxone-resistant gonorrhea.
"Ceftriaxone became the one remaining first-line option. The antimicrobial pipeline is running dry, and N. gonorrhoeae continues to acquire resistance. We wanted to repurpose approved drugs that could be used for salvage treatment on cetriaxone failures and for patients allergic to cephalosporins," Dr. Kirkcaldy said.
The study enrolled patients aged 15-60 years who presented at any one of five participating U.S. medical centers with uncomplicated, untreated urogenital gonorrhea. The 401 patients who completed the study averaged about 28 years of age. About a third were men who have sex with men, slightly more than half were men who have sex with women, and about 10% were women. Just under 10% were HIV positive. Patients received either 240 mg gentamicin as an intramuscular injection at two separate sites (with the dosage adjusted downward for patients weighing 45 kg or less) or a single, 320-mg oral dose of gemifloxacin. All patients also received a 2-g oral dose of azithromycin.
Gentamicin, a drug primarily used for hospitalized patients with endocarditis, was chosen because of its known, modest (about 91.5%) efficacy for gonorrhea, low risk of toxicity with a single dose in otherwise healthy men and women, and its U.S. availability, Dr. Kirkcaldy said. Gemifloxacin was selected because it’s an oral drug approved for sale in the United States that’s been shown to be active in vitro against ciprofloxacin-resistant strains of N. gonorrhoeae. Azithromycin was added because of its known activity against gonorrhea, although with recent eradication rates of 97%-99%, it is now deemed too unreliable for monotherapy.
The study's primary efficacy endpoint was the percentage of patients who successfully received treatment and returned for a follow-up microbiologic test of eradication. This happened in all 202 patients treated with gentamicin plus azithromycin, and in 198 of the 199 (99.5%) treated with gemifloxacin plus azithromycin. A small percentage of the patients enrolled also had rectal or pharyngeal gonococcal infections in addition to their urogenital infection. Both treatments were 100% effective at eradicating infections at those sites, but the numbers were too small to conclusively prove efficacy for these sites, he said.
These new data will be considered as the CDC develops its next revision of the U.S. STD treatment guidelines, due out next year, Dr. Kirkcaldy said.
The study was sponsored by the National Institute of Allergy and Infectious Diseases. Dr. Kirkcaldy said he had no relevant financial disclosures.
On Twitter @mitchelzoler
VIENNA – Two combination regimens using antibiotics already approved for U.S. use eradicated urogenital gonorrhea infections with virtually 100% efficacy in a multicenter U.S. study with about 400 patients, providing solid evidence for the potential of both combinations as backup treatments for Neisseria gonorrhoeae at a time when resistance in the pathogen has whittled standard treatment options down to one primary drug, ceftriaxone.
"The emergence of cephalosporin resistance complicates empiric treatment" of gonorrhea infections, Dr. Robert D. Kirkcaldy said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
The two new combinations he and his associates tested – gentamicin plus azithromycin (Zithromax) and gemifloxicin (Factive) plus azithromycin – "may be useful for patients unsuccessfully treated with ceftriaxone or patients with a cephalosporin allergy, but neither [of the two new combinations] is a magic bullet," said Dr. Kirkcaldy, a medical epidemiologist in the division of STD prevention at the Centers for Disease Control and Prevention. "The gastrointestinal side effects [seen with both new regimens] may limit their routine use."
Gastrointestinal adverse effects occurred in 47% of the patients who received gentamicin plus azithromycin and in 55% of those who got gemifloxacin plus azithromycin. But Dr. Kirkcaldy highlighted that all of these effects were mild to moderate, none was serious, and the vast majority of patients were able to hold the oral drugs they received for more than an hour; 3% of the gentamicin recipients and 8% of the gemifloxacin recipients vomited within an hour of receiving treatment and were excluded from the primary efficacy analysis as a result.
"These trial results are an exciting step in the right direction in the fight against drug-resistant gonorrhea, but patients need more oral options with fewer side effects," Dr. Gail Bolan, director of the CDC’s division of STD prevention, commented in a written statement.
Less than a year ago, in August 2012, a panel of CDC staffers and outside experts released updated recommendations for treating all types of uncomplicated gonococcal infections, including anorectal, pharyngeal, and urogenital infections. The CDC recommended a single intramuscular injection of ceftriaxone (Rocephin) along with a single oral dose of azithromycin or a 7-day course of doxycycline given b.i.d. (MMWR 2012;61:590-4).
This recommendation came about because of an increasing U.S. incidence of gonococcal infections by strains resistant to cefixime (Suprax), the prior mainstay of treatment. The need to move from cefixime to ceftriaxone also concerned the CDC. The agency projects that patients may soon also face ceftriaxone-resistant gonorrhea.
"Ceftriaxone became the one remaining first-line option. The antimicrobial pipeline is running dry, and N. gonorrhoeae continues to acquire resistance. We wanted to repurpose approved drugs that could be used for salvage treatment on cetriaxone failures and for patients allergic to cephalosporins," Dr. Kirkcaldy said.
The study enrolled patients aged 15-60 years who presented at any one of five participating U.S. medical centers with uncomplicated, untreated urogenital gonorrhea. The 401 patients who completed the study averaged about 28 years of age. About a third were men who have sex with men, slightly more than half were men who have sex with women, and about 10% were women. Just under 10% were HIV positive. Patients received either 240 mg gentamicin as an intramuscular injection at two separate sites (with the dosage adjusted downward for patients weighing 45 kg or less) or a single, 320-mg oral dose of gemifloxacin. All patients also received a 2-g oral dose of azithromycin.
Gentamicin, a drug primarily used for hospitalized patients with endocarditis, was chosen because of its known, modest (about 91.5%) efficacy for gonorrhea, low risk of toxicity with a single dose in otherwise healthy men and women, and its U.S. availability, Dr. Kirkcaldy said. Gemifloxacin was selected because it’s an oral drug approved for sale in the United States that’s been shown to be active in vitro against ciprofloxacin-resistant strains of N. gonorrhoeae. Azithromycin was added because of its known activity against gonorrhea, although with recent eradication rates of 97%-99%, it is now deemed too unreliable for monotherapy.
The study's primary efficacy endpoint was the percentage of patients who successfully received treatment and returned for a follow-up microbiologic test of eradication. This happened in all 202 patients treated with gentamicin plus azithromycin, and in 198 of the 199 (99.5%) treated with gemifloxacin plus azithromycin. A small percentage of the patients enrolled also had rectal or pharyngeal gonococcal infections in addition to their urogenital infection. Both treatments were 100% effective at eradicating infections at those sites, but the numbers were too small to conclusively prove efficacy for these sites, he said.
These new data will be considered as the CDC develops its next revision of the U.S. STD treatment guidelines, due out next year, Dr. Kirkcaldy said.
The study was sponsored by the National Institute of Allergy and Infectious Diseases. Dr. Kirkcaldy said he had no relevant financial disclosures.
On Twitter @mitchelzoler
VIENNA – Two combination regimens using antibiotics already approved for U.S. use eradicated urogenital gonorrhea infections with virtually 100% efficacy in a multicenter U.S. study with about 400 patients, providing solid evidence for the potential of both combinations as backup treatments for Neisseria gonorrhoeae at a time when resistance in the pathogen has whittled standard treatment options down to one primary drug, ceftriaxone.
"The emergence of cephalosporin resistance complicates empiric treatment" of gonorrhea infections, Dr. Robert D. Kirkcaldy said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
The two new combinations he and his associates tested – gentamicin plus azithromycin (Zithromax) and gemifloxicin (Factive) plus azithromycin – "may be useful for patients unsuccessfully treated with ceftriaxone or patients with a cephalosporin allergy, but neither [of the two new combinations] is a magic bullet," said Dr. Kirkcaldy, a medical epidemiologist in the division of STD prevention at the Centers for Disease Control and Prevention. "The gastrointestinal side effects [seen with both new regimens] may limit their routine use."
Gastrointestinal adverse effects occurred in 47% of the patients who received gentamicin plus azithromycin and in 55% of those who got gemifloxacin plus azithromycin. But Dr. Kirkcaldy highlighted that all of these effects were mild to moderate, none was serious, and the vast majority of patients were able to hold the oral drugs they received for more than an hour; 3% of the gentamicin recipients and 8% of the gemifloxacin recipients vomited within an hour of receiving treatment and were excluded from the primary efficacy analysis as a result.
"These trial results are an exciting step in the right direction in the fight against drug-resistant gonorrhea, but patients need more oral options with fewer side effects," Dr. Gail Bolan, director of the CDC’s division of STD prevention, commented in a written statement.
Less than a year ago, in August 2012, a panel of CDC staffers and outside experts released updated recommendations for treating all types of uncomplicated gonococcal infections, including anorectal, pharyngeal, and urogenital infections. The CDC recommended a single intramuscular injection of ceftriaxone (Rocephin) along with a single oral dose of azithromycin or a 7-day course of doxycycline given b.i.d. (MMWR 2012;61:590-4).
This recommendation came about because of an increasing U.S. incidence of gonococcal infections by strains resistant to cefixime (Suprax), the prior mainstay of treatment. The need to move from cefixime to ceftriaxone also concerned the CDC. The agency projects that patients may soon also face ceftriaxone-resistant gonorrhea.
"Ceftriaxone became the one remaining first-line option. The antimicrobial pipeline is running dry, and N. gonorrhoeae continues to acquire resistance. We wanted to repurpose approved drugs that could be used for salvage treatment on cetriaxone failures and for patients allergic to cephalosporins," Dr. Kirkcaldy said.
The study enrolled patients aged 15-60 years who presented at any one of five participating U.S. medical centers with uncomplicated, untreated urogenital gonorrhea. The 401 patients who completed the study averaged about 28 years of age. About a third were men who have sex with men, slightly more than half were men who have sex with women, and about 10% were women. Just under 10% were HIV positive. Patients received either 240 mg gentamicin as an intramuscular injection at two separate sites (with the dosage adjusted downward for patients weighing 45 kg or less) or a single, 320-mg oral dose of gemifloxacin. All patients also received a 2-g oral dose of azithromycin.
Gentamicin, a drug primarily used for hospitalized patients with endocarditis, was chosen because of its known, modest (about 91.5%) efficacy for gonorrhea, low risk of toxicity with a single dose in otherwise healthy men and women, and its U.S. availability, Dr. Kirkcaldy said. Gemifloxacin was selected because it’s an oral drug approved for sale in the United States that’s been shown to be active in vitro against ciprofloxacin-resistant strains of N. gonorrhoeae. Azithromycin was added because of its known activity against gonorrhea, although with recent eradication rates of 97%-99%, it is now deemed too unreliable for monotherapy.
The study's primary efficacy endpoint was the percentage of patients who successfully received treatment and returned for a follow-up microbiologic test of eradication. This happened in all 202 patients treated with gentamicin plus azithromycin, and in 198 of the 199 (99.5%) treated with gemifloxacin plus azithromycin. A small percentage of the patients enrolled also had rectal or pharyngeal gonococcal infections in addition to their urogenital infection. Both treatments were 100% effective at eradicating infections at those sites, but the numbers were too small to conclusively prove efficacy for these sites, he said.
These new data will be considered as the CDC develops its next revision of the U.S. STD treatment guidelines, due out next year, Dr. Kirkcaldy said.
The study was sponsored by the National Institute of Allergy and Infectious Diseases. Dr. Kirkcaldy said he had no relevant financial disclosures.
On Twitter @mitchelzoler
AT THE STI & AIDS WORLD CONGRESS 2013
Two approved antibiotics show new gonorrhea efficacy
VIENNA – Two combination regimens using antibiotics already approved for U.S. use eradicated urogenital gonorrhea infections with virtually 100% efficacy in a multicenter U.S. study with about 400 patients, providing solid evidence for the potential of both combinations as backup treatments for Neisseria gonorrhoeae at a time when resistance in the pathogen has whittled standard treatment options down to one primary drug, ceftriaxone.
"The emergence of cephalosporin resistance complicates empiric treatment" of gonorrhea infections, Dr. Robert D. Kirkcaldy said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
The two new combinations he and his associates tested – gentamicin plus azithromycin (Zithromax) and gemifloxicin (Factive) plus azithromycin – "may be useful for patients unsuccessfully treated with ceftriaxone or patients with a cephalosporin allergy, but neither [of the two new combinations] is a magic bullet," said Dr. Kirkcaldy, a medical epidemiologist in the division of STD prevention at the Centers for Disease Control and Prevention. "The gastrointestinal side effects [seen with both new regimens] may limit their routine use."
Gastrointestinal adverse effects occurred in 47% of the patients who received gentamicin plus azithromycin and in 55% of those who got gemifloxacin plus azithromycin. But Dr. Kirkcaldy highlighted that all of these effects were mild to moderate, none was serious, and the vast majority of patients were able to hold the oral drugs they received for more than an hour; 3% of the gentamicin recipients and 8% of the gemifloxacin recipients vomited within an hour of receiving treatment and were excluded from the primary efficacy analysis as a result.
"These trial results are an exciting step in the right direction in the fight against drug-resistant gonorrhea, but patients need more oral options with fewer side effects," Dr. Gail Bolan, director of the CDC’s division of STD prevention, commented in a written statement.
Less than a year ago, in August 2012, a panel of CDC staffers and outside experts released updated recommendations for treating all types of uncomplicated gonococcal infections, including anorectal, pharyngeal, and urogenital infections. The CDC recommended a single intramuscular injection of ceftriaxone (Rocephin) along with a single oral dose of azithromycin or a 7-day course of doxycycline given b.i.d. (MMWR 2012;61:590-4).
This recommendation came about because of an increasing U.S. incidence of gonococcal infections by strains resistant to cefixime (Suprax), the prior mainstay of treatment. The need to move from cefixime to ceftriaxone also concerned the CDC. The agency projects that patients may soon also face ceftriaxone-resistant gonorrhea.
"Ceftriaxone became the one remaining first-line option. The antimicrobial pipeline is running dry, and N. gonorrhoeae continues to acquire resistance. We wanted to repurpose approved drugs that could be used for salvage treatment on cetriaxone failures and for patients allergic to cephalosporins," Dr. Kirkcaldy said.
The study enrolled patients aged 15-60 years who presented at any one of five participating U.S. medical centers with uncomplicated, untreated urogenital gonorrhea. The 401 patients who completed the study averaged about 28 years of age. About a third were men who have sex with men, slightly more than half were men who have sex with women, and about 10% were women. Just under 10% were HIV positive. Patients received either 240 mg gentamicin as an intramuscular injection at two separate sites (with the dosage adjusted downward for patients weighing 45 kg or less) or a single, 320-mg oral dose of gemifloxacin. All patients also received a 2-g oral dose of azithromycin.
Gentamicin, a drug primarily used for hospitalized patients with endocarditis, was chosen because of its known, modest (about 91.5%) efficacy for gonorrhea, low risk of toxicity with a single dose in otherwise healthy men and women, and its U.S. availability, Dr. Kirkcaldy said. Gemifloxacin was selected because it’s an oral drug approved for sale in the United States that’s been shown to be active in vitro against ciprofloxacin-resistant strains of N. gonorrhoeae. Azithromycin was added because of its known activity against gonorrhea, although with recent eradication rates of 97%-99%, it is now deemed too unreliable for monotherapy.
The study's primary efficacy endpoint was the percentage of patients who successfully received treatment and returned for a follow-up microbiologic test of eradication. This happened in all 202 patients treated with gentamicin plus azithromycin, and in 198 of the 199 (99.5%) treated with gemifloxacin plus azithromycin. A small percentage of the patients enrolled also had rectal or pharyngeal gonococcal infections in addition to their urogenital infection. Both treatments were 100% effective at eradicating infections at those sites, but the numbers were too small to conclusively prove efficacy for these sites, he said.
These new data will be considered as the CDC develops its next revision of the U.S. STD treatment guidelines, due out next year, Dr. Kirkcaldy said.
The study was sponsored by the National Institute of Allergy and Infectious Diseases. Dr. Kirkcaldy said he had no relevant financial disclosures.
On Twitter @mitchelzoler
VIENNA – Two combination regimens using antibiotics already approved for U.S. use eradicated urogenital gonorrhea infections with virtually 100% efficacy in a multicenter U.S. study with about 400 patients, providing solid evidence for the potential of both combinations as backup treatments for Neisseria gonorrhoeae at a time when resistance in the pathogen has whittled standard treatment options down to one primary drug, ceftriaxone.
"The emergence of cephalosporin resistance complicates empiric treatment" of gonorrhea infections, Dr. Robert D. Kirkcaldy said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
The two new combinations he and his associates tested – gentamicin plus azithromycin (Zithromax) and gemifloxicin (Factive) plus azithromycin – "may be useful for patients unsuccessfully treated with ceftriaxone or patients with a cephalosporin allergy, but neither [of the two new combinations] is a magic bullet," said Dr. Kirkcaldy, a medical epidemiologist in the division of STD prevention at the Centers for Disease Control and Prevention. "The gastrointestinal side effects [seen with both new regimens] may limit their routine use."
Gastrointestinal adverse effects occurred in 47% of the patients who received gentamicin plus azithromycin and in 55% of those who got gemifloxacin plus azithromycin. But Dr. Kirkcaldy highlighted that all of these effects were mild to moderate, none was serious, and the vast majority of patients were able to hold the oral drugs they received for more than an hour; 3% of the gentamicin recipients and 8% of the gemifloxacin recipients vomited within an hour of receiving treatment and were excluded from the primary efficacy analysis as a result.
"These trial results are an exciting step in the right direction in the fight against drug-resistant gonorrhea, but patients need more oral options with fewer side effects," Dr. Gail Bolan, director of the CDC’s division of STD prevention, commented in a written statement.
Less than a year ago, in August 2012, a panel of CDC staffers and outside experts released updated recommendations for treating all types of uncomplicated gonococcal infections, including anorectal, pharyngeal, and urogenital infections. The CDC recommended a single intramuscular injection of ceftriaxone (Rocephin) along with a single oral dose of azithromycin or a 7-day course of doxycycline given b.i.d. (MMWR 2012;61:590-4).
This recommendation came about because of an increasing U.S. incidence of gonococcal infections by strains resistant to cefixime (Suprax), the prior mainstay of treatment. The need to move from cefixime to ceftriaxone also concerned the CDC. The agency projects that patients may soon also face ceftriaxone-resistant gonorrhea.
"Ceftriaxone became the one remaining first-line option. The antimicrobial pipeline is running dry, and N. gonorrhoeae continues to acquire resistance. We wanted to repurpose approved drugs that could be used for salvage treatment on cetriaxone failures and for patients allergic to cephalosporins," Dr. Kirkcaldy said.
The study enrolled patients aged 15-60 years who presented at any one of five participating U.S. medical centers with uncomplicated, untreated urogenital gonorrhea. The 401 patients who completed the study averaged about 28 years of age. About a third were men who have sex with men, slightly more than half were men who have sex with women, and about 10% were women. Just under 10% were HIV positive. Patients received either 240 mg gentamicin as an intramuscular injection at two separate sites (with the dosage adjusted downward for patients weighing 45 kg or less) or a single, 320-mg oral dose of gemifloxacin. All patients also received a 2-g oral dose of azithromycin.
Gentamicin, a drug primarily used for hospitalized patients with endocarditis, was chosen because of its known, modest (about 91.5%) efficacy for gonorrhea, low risk of toxicity with a single dose in otherwise healthy men and women, and its U.S. availability, Dr. Kirkcaldy said. Gemifloxacin was selected because it’s an oral drug approved for sale in the United States that’s been shown to be active in vitro against ciprofloxacin-resistant strains of N. gonorrhoeae. Azithromycin was added because of its known activity against gonorrhea, although with recent eradication rates of 97%-99%, it is now deemed too unreliable for monotherapy.
The study's primary efficacy endpoint was the percentage of patients who successfully received treatment and returned for a follow-up microbiologic test of eradication. This happened in all 202 patients treated with gentamicin plus azithromycin, and in 198 of the 199 (99.5%) treated with gemifloxacin plus azithromycin. A small percentage of the patients enrolled also had rectal or pharyngeal gonococcal infections in addition to their urogenital infection. Both treatments were 100% effective at eradicating infections at those sites, but the numbers were too small to conclusively prove efficacy for these sites, he said.
These new data will be considered as the CDC develops its next revision of the U.S. STD treatment guidelines, due out next year, Dr. Kirkcaldy said.
The study was sponsored by the National Institute of Allergy and Infectious Diseases. Dr. Kirkcaldy said he had no relevant financial disclosures.
On Twitter @mitchelzoler
VIENNA – Two combination regimens using antibiotics already approved for U.S. use eradicated urogenital gonorrhea infections with virtually 100% efficacy in a multicenter U.S. study with about 400 patients, providing solid evidence for the potential of both combinations as backup treatments for Neisseria gonorrhoeae at a time when resistance in the pathogen has whittled standard treatment options down to one primary drug, ceftriaxone.
"The emergence of cephalosporin resistance complicates empiric treatment" of gonorrhea infections, Dr. Robert D. Kirkcaldy said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
The two new combinations he and his associates tested – gentamicin plus azithromycin (Zithromax) and gemifloxicin (Factive) plus azithromycin – "may be useful for patients unsuccessfully treated with ceftriaxone or patients with a cephalosporin allergy, but neither [of the two new combinations] is a magic bullet," said Dr. Kirkcaldy, a medical epidemiologist in the division of STD prevention at the Centers for Disease Control and Prevention. "The gastrointestinal side effects [seen with both new regimens] may limit their routine use."
Gastrointestinal adverse effects occurred in 47% of the patients who received gentamicin plus azithromycin and in 55% of those who got gemifloxacin plus azithromycin. But Dr. Kirkcaldy highlighted that all of these effects were mild to moderate, none was serious, and the vast majority of patients were able to hold the oral drugs they received for more than an hour; 3% of the gentamicin recipients and 8% of the gemifloxacin recipients vomited within an hour of receiving treatment and were excluded from the primary efficacy analysis as a result.
"These trial results are an exciting step in the right direction in the fight against drug-resistant gonorrhea, but patients need more oral options with fewer side effects," Dr. Gail Bolan, director of the CDC’s division of STD prevention, commented in a written statement.
Less than a year ago, in August 2012, a panel of CDC staffers and outside experts released updated recommendations for treating all types of uncomplicated gonococcal infections, including anorectal, pharyngeal, and urogenital infections. The CDC recommended a single intramuscular injection of ceftriaxone (Rocephin) along with a single oral dose of azithromycin or a 7-day course of doxycycline given b.i.d. (MMWR 2012;61:590-4).
This recommendation came about because of an increasing U.S. incidence of gonococcal infections by strains resistant to cefixime (Suprax), the prior mainstay of treatment. The need to move from cefixime to ceftriaxone also concerned the CDC. The agency projects that patients may soon also face ceftriaxone-resistant gonorrhea.
"Ceftriaxone became the one remaining first-line option. The antimicrobial pipeline is running dry, and N. gonorrhoeae continues to acquire resistance. We wanted to repurpose approved drugs that could be used for salvage treatment on cetriaxone failures and for patients allergic to cephalosporins," Dr. Kirkcaldy said.
The study enrolled patients aged 15-60 years who presented at any one of five participating U.S. medical centers with uncomplicated, untreated urogenital gonorrhea. The 401 patients who completed the study averaged about 28 years of age. About a third were men who have sex with men, slightly more than half were men who have sex with women, and about 10% were women. Just under 10% were HIV positive. Patients received either 240 mg gentamicin as an intramuscular injection at two separate sites (with the dosage adjusted downward for patients weighing 45 kg or less) or a single, 320-mg oral dose of gemifloxacin. All patients also received a 2-g oral dose of azithromycin.
Gentamicin, a drug primarily used for hospitalized patients with endocarditis, was chosen because of its known, modest (about 91.5%) efficacy for gonorrhea, low risk of toxicity with a single dose in otherwise healthy men and women, and its U.S. availability, Dr. Kirkcaldy said. Gemifloxacin was selected because it’s an oral drug approved for sale in the United States that’s been shown to be active in vitro against ciprofloxacin-resistant strains of N. gonorrhoeae. Azithromycin was added because of its known activity against gonorrhea, although with recent eradication rates of 97%-99%, it is now deemed too unreliable for monotherapy.
The study's primary efficacy endpoint was the percentage of patients who successfully received treatment and returned for a follow-up microbiologic test of eradication. This happened in all 202 patients treated with gentamicin plus azithromycin, and in 198 of the 199 (99.5%) treated with gemifloxacin plus azithromycin. A small percentage of the patients enrolled also had rectal or pharyngeal gonococcal infections in addition to their urogenital infection. Both treatments were 100% effective at eradicating infections at those sites, but the numbers were too small to conclusively prove efficacy for these sites, he said.
These new data will be considered as the CDC develops its next revision of the U.S. STD treatment guidelines, due out next year, Dr. Kirkcaldy said.
The study was sponsored by the National Institute of Allergy and Infectious Diseases. Dr. Kirkcaldy said he had no relevant financial disclosures.
On Twitter @mitchelzoler
AT THE STI & AIDS WORLD CONGRESS 2013
Major finding: Gentamicin plus azithromycin was 100% effective and gemfloxacin plus azithromycin was 99.5% effective for eradication of urogenital gonorrhea.
Data source: An open-label study of two antibiotic regimens in 401 patients at five U.S. sites.
Disclosures: The study was sponsored by the National Institute of Allergy and Infectious Diseases. Dr. Kirkcaldy said he had no relevant financial disclosures.
CDC moves to cast a wider Chlamydia screening net
VIENNA – Staffers at the Centers for Disease Control and Prevention are developing and will soon start prospectively testing a new approach of universal, opt-out chlamydial infection screening for girls and women aged 15-24 years. In making this change, CDC is recognizing that current U.S. recommendations for sexually active girls and women in this age group are producing woefully low screening rates of roughly 30%, according to CDC staffers.
CDC researchers developing this new approach to Chlamydia trachomatis screening performed a cost-effectiveness analysis of this screening paradigm and found it was "very cost effective," with an estimated incremental cost of $1,372 for each quality-adjusted life year gained. In contrast, the current risk-based approach to screening for chlamydial infections among women in this age range has a cost effectiveness of about $41,000 per quality-adjusted life year gained, Dr. Karen Hoover said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
According to a preliminary economic analysis by Kwame Owusu-Edusei Jr., Ph.D., of the CDC’s Division of STD Prevention in Atlanta, universal, opt-out screening may prove to have the added benefit of boosting screening rates from the current level of 30% overall among sexually active girls and women aged 15-24 and as low as 11% in sexually-active 15-year-old girls to an overall rate of 52%. The CDC’s planned changes are expected to raise the participation level to at least 75% among the sexually-active subgroup (and an expected 5% participation rate among those who are not sexually active in this age group, who would be advised not to undergo screening).
The higher screening uptake rate should, within less than 5 years, cut the prevalence of chlamydial infection in these girls and women from the current levels of 3% to nearly 1%, and in the same time frame it should also drop infection rates among men from just over 2% to below 1%, said Dr. Hoover, an ob.gyn. and medical epidemiologist in the CDC’s Division of STD Prevention.
Another benefit would be removing the stigma that the current, risk-based system generates by making many girls and women feel that they have had "bad" sex or promiscuous sex because they are now at risk of harboring chlamydial infection and need screening, Dr. Hoover said. Universal screening with opt-out would "normalize" screening in the eyes of the target population.
Routine, annual screening of sexually-active U.S. girls and women aged 24 years and younger for chlamydial infection was first recommended by the U.S. Preventive Services Task Force for about a decade, and most recently in 2007 (Ann. Int. Med. 2007;147:128-34). The CDC also recommends this screening approach for girls and women aged 25 years and younger (MMWR 2010;59(RR12):1-110).
Although the new screening model is still in development, it would likely be patient centered and hinge on having the reception staffs at primary care physicians’ offices routinely ask girls and women in the target age group to supply a urine specimen or self-administered vaginal swab at the start of all visits to any primary care provider – gynecologists, pediatricians, family practice physicians, or internal medicine physicians – along with an information sheet or pamphlet. The process would resemble the way that pregnant U.S. women are routinely asked to supply a urine specimen at the start of all their antenatal office visits. "This is very simple for clinics to implement," Dr. Hoover said at the meeting.
Routine specimen collection from all girls and women in the target group would help remove the stigma from specimen collection, Dr. Hoover said in an interview. The information patients receive would encourage them to discuss screening with their physicians, when they could exercise their opt out.
Although this approach could result in a modest amount of overtesting, the huge cost-effectiveness advantage of universal opt-out screening compared with the current, risk-based approach leaves a lot of margin to accommodate some overtesting and still be cost effective.
The only other infectious disease currently screened in the United States by a universal, opt-out system in a target age group is HIV, she noted.
Dr. Hoover said that the CDC would like to pilot universal testing in several types of U.S. clinical practice. Testing of the screening model should start within a few years, she said.
"We need a paradigm shift; we need to do this differently. As long as we continue to rely on clinicians to change their behavior [and initiate more screening than they currently do] we will never get to where we want to be" with C. trachomatis screening, she said.
Dr. Hoover had no disclosures.
On Twitter @mitchelzoler
VIENNA – Staffers at the Centers for Disease Control and Prevention are developing and will soon start prospectively testing a new approach of universal, opt-out chlamydial infection screening for girls and women aged 15-24 years. In making this change, CDC is recognizing that current U.S. recommendations for sexually active girls and women in this age group are producing woefully low screening rates of roughly 30%, according to CDC staffers.
CDC researchers developing this new approach to Chlamydia trachomatis screening performed a cost-effectiveness analysis of this screening paradigm and found it was "very cost effective," with an estimated incremental cost of $1,372 for each quality-adjusted life year gained. In contrast, the current risk-based approach to screening for chlamydial infections among women in this age range has a cost effectiveness of about $41,000 per quality-adjusted life year gained, Dr. Karen Hoover said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
According to a preliminary economic analysis by Kwame Owusu-Edusei Jr., Ph.D., of the CDC’s Division of STD Prevention in Atlanta, universal, opt-out screening may prove to have the added benefit of boosting screening rates from the current level of 30% overall among sexually active girls and women aged 15-24 and as low as 11% in sexually-active 15-year-old girls to an overall rate of 52%. The CDC’s planned changes are expected to raise the participation level to at least 75% among the sexually-active subgroup (and an expected 5% participation rate among those who are not sexually active in this age group, who would be advised not to undergo screening).
The higher screening uptake rate should, within less than 5 years, cut the prevalence of chlamydial infection in these girls and women from the current levels of 3% to nearly 1%, and in the same time frame it should also drop infection rates among men from just over 2% to below 1%, said Dr. Hoover, an ob.gyn. and medical epidemiologist in the CDC’s Division of STD Prevention.
Another benefit would be removing the stigma that the current, risk-based system generates by making many girls and women feel that they have had "bad" sex or promiscuous sex because they are now at risk of harboring chlamydial infection and need screening, Dr. Hoover said. Universal screening with opt-out would "normalize" screening in the eyes of the target population.
Routine, annual screening of sexually-active U.S. girls and women aged 24 years and younger for chlamydial infection was first recommended by the U.S. Preventive Services Task Force for about a decade, and most recently in 2007 (Ann. Int. Med. 2007;147:128-34). The CDC also recommends this screening approach for girls and women aged 25 years and younger (MMWR 2010;59(RR12):1-110).
Although the new screening model is still in development, it would likely be patient centered and hinge on having the reception staffs at primary care physicians’ offices routinely ask girls and women in the target age group to supply a urine specimen or self-administered vaginal swab at the start of all visits to any primary care provider – gynecologists, pediatricians, family practice physicians, or internal medicine physicians – along with an information sheet or pamphlet. The process would resemble the way that pregnant U.S. women are routinely asked to supply a urine specimen at the start of all their antenatal office visits. "This is very simple for clinics to implement," Dr. Hoover said at the meeting.
Routine specimen collection from all girls and women in the target group would help remove the stigma from specimen collection, Dr. Hoover said in an interview. The information patients receive would encourage them to discuss screening with their physicians, when they could exercise their opt out.
Although this approach could result in a modest amount of overtesting, the huge cost-effectiveness advantage of universal opt-out screening compared with the current, risk-based approach leaves a lot of margin to accommodate some overtesting and still be cost effective.
The only other infectious disease currently screened in the United States by a universal, opt-out system in a target age group is HIV, she noted.
Dr. Hoover said that the CDC would like to pilot universal testing in several types of U.S. clinical practice. Testing of the screening model should start within a few years, she said.
"We need a paradigm shift; we need to do this differently. As long as we continue to rely on clinicians to change their behavior [and initiate more screening than they currently do] we will never get to where we want to be" with C. trachomatis screening, she said.
Dr. Hoover had no disclosures.
On Twitter @mitchelzoler
VIENNA – Staffers at the Centers for Disease Control and Prevention are developing and will soon start prospectively testing a new approach of universal, opt-out chlamydial infection screening for girls and women aged 15-24 years. In making this change, CDC is recognizing that current U.S. recommendations for sexually active girls and women in this age group are producing woefully low screening rates of roughly 30%, according to CDC staffers.
CDC researchers developing this new approach to Chlamydia trachomatis screening performed a cost-effectiveness analysis of this screening paradigm and found it was "very cost effective," with an estimated incremental cost of $1,372 for each quality-adjusted life year gained. In contrast, the current risk-based approach to screening for chlamydial infections among women in this age range has a cost effectiveness of about $41,000 per quality-adjusted life year gained, Dr. Karen Hoover said at the joint meeting of the International Society for Sexually Transmitted Diseases Research and the International Union Against Sexually Transmitted Infections.
According to a preliminary economic analysis by Kwame Owusu-Edusei Jr., Ph.D., of the CDC’s Division of STD Prevention in Atlanta, universal, opt-out screening may prove to have the added benefit of boosting screening rates from the current level of 30% overall among sexually active girls and women aged 15-24 and as low as 11% in sexually-active 15-year-old girls to an overall rate of 52%. The CDC’s planned changes are expected to raise the participation level to at least 75% among the sexually-active subgroup (and an expected 5% participation rate among those who are not sexually active in this age group, who would be advised not to undergo screening).
The higher screening uptake rate should, within less than 5 years, cut the prevalence of chlamydial infection in these girls and women from the current levels of 3% to nearly 1%, and in the same time frame it should also drop infection rates among men from just over 2% to below 1%, said Dr. Hoover, an ob.gyn. and medical epidemiologist in the CDC’s Division of STD Prevention.
Another benefit would be removing the stigma that the current, risk-based system generates by making many girls and women feel that they have had "bad" sex or promiscuous sex because they are now at risk of harboring chlamydial infection and need screening, Dr. Hoover said. Universal screening with opt-out would "normalize" screening in the eyes of the target population.
Routine, annual screening of sexually-active U.S. girls and women aged 24 years and younger for chlamydial infection was first recommended by the U.S. Preventive Services Task Force for about a decade, and most recently in 2007 (Ann. Int. Med. 2007;147:128-34). The CDC also recommends this screening approach for girls and women aged 25 years and younger (MMWR 2010;59(RR12):1-110).
Although the new screening model is still in development, it would likely be patient centered and hinge on having the reception staffs at primary care physicians’ offices routinely ask girls and women in the target age group to supply a urine specimen or self-administered vaginal swab at the start of all visits to any primary care provider – gynecologists, pediatricians, family practice physicians, or internal medicine physicians – along with an information sheet or pamphlet. The process would resemble the way that pregnant U.S. women are routinely asked to supply a urine specimen at the start of all their antenatal office visits. "This is very simple for clinics to implement," Dr. Hoover said at the meeting.
Routine specimen collection from all girls and women in the target group would help remove the stigma from specimen collection, Dr. Hoover said in an interview. The information patients receive would encourage them to discuss screening with their physicians, when they could exercise their opt out.
Although this approach could result in a modest amount of overtesting, the huge cost-effectiveness advantage of universal opt-out screening compared with the current, risk-based approach leaves a lot of margin to accommodate some overtesting and still be cost effective.
The only other infectious disease currently screened in the United States by a universal, opt-out system in a target age group is HIV, she noted.
Dr. Hoover said that the CDC would like to pilot universal testing in several types of U.S. clinical practice. Testing of the screening model should start within a few years, she said.
"We need a paradigm shift; we need to do this differently. As long as we continue to rely on clinicians to change their behavior [and initiate more screening than they currently do] we will never get to where we want to be" with C. trachomatis screening, she said.
Dr. Hoover had no disclosures.
On Twitter @mitchelzoler
AT THE STI & AIDS WORLD CONGRESS 2013
Major finding: Universal, opt-out screening for chlamydial infection in U.S. women aged 15-24 years was projected to cost $1,372 per quality-adjusted life year.
Data source: A cost-effectiveness model developed by staffers at the Centers for Disease Control and Prevention.
Disclosures: Dr. Hoover had no disclosures.
