ASA Monitor July 2023, Vol. 87, 12–34.
Doxycycline reduces sexually transmitted infections by two-thirds
A study funded by the National Institute of Allergy and Infectious Diseases (NIAID) of men who have sex with men and transgender women found the oral antibiotic doxycycline prevented the acquisition of sexually transmitted infections (STIs) when taken within 72 hours of having condomless sex. The post-exposure approach, doxy-PEP, resulted in a two-thirds reduction in the incidence of syphilis, gonorrhea, and chlamydia among the study participants, all of whom reported having an STI within the previous year. According to the CDC, an estimated 2.5 million cases of syphilis, gonorrhea, and chlamydia occurred in 2021 – up from 2.4 million cases in 2020 – all of which can lead to brain and nerve problems, blindness, infertility, and increased risk of HIV acquisition. Antimicrobial resistance among STIs is an emerging public health threat. The study enrolled over 500 adults assigned male sex at birth; reported sexual activity with a man in the previous year; diagnosed with HIV or taking or planning to take pre-exposure prophylaxis (PrEP) medication to prevent HIV acquisition; and diagnosed with gonorrhea, chlamydia, or early syphilis in the prior year. Over 300 participants were taking HIV PrEP medications, and 174 participants were people living with HIV. Participants were randomly assigned to receive either doxy-PEP or standard of care. Among participants on HIV PrEP, at least one or more STIs were diagnosed in 10.7% of quarterly clinic visits in the doxy-PEP study arm compared to 31.9% of visits in the standard of care arm. Among study participants living with HIV, one or more STIs were diagnosed in 11.8% of quarterly visits in the doxy-PEP arm versus 30.5% in the standard of care arm. Gonorrhea was the most frequently diagnosed STI in the study. Doxy-PEP may offer less protection against gonorrhea strains that are already tetracycline-resistant. Wider population-based surveillance for this type of resistance is needed.
FDA approves allogeneic cord blood-based cell therapy for patients with blood cancers
The U.S. Food and Drug Administration (FDA) has approved Omisirge (omidubicel-onlv), a substantially modified allogeneic cord blood-based cell therapy to quicken the recovery of neutrophils in the body and reduce the risk of infection. The product is intended for patients with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen. Recovering white blood cells reduces the possibility of serious or overwhelming infection associated with stem cell transplantation. Omisirge, administered as a single intravenous dose, is composed of patient-specific, human allogeneic stem cells from umbilical cord blood that are processed and cultured with nicotinamide (a form of vitamin B3). A randomized, multicenter study comparing transplantation of Omisirge to transplantation of umbilical cord blood enrolled 125 subjects with confirmed blood cancers. Eighty-seven percent of subjects who received Omisirge achieved neutrophil recovery with a median of 12 days following treatment with the product, compared to 83% of subjects who received umbilical cord blood transplantation and who achieved neutrophil recovery with a median of 22 days. Bacterial or fungal infections by 100 days following transplantation were seen in 39% of subjects receiving Omisirge versus 60% of subjects in the control group who received umbilical cord blood.
NIH study stopped early to investigate effect of statin on cardiovascular disease in people living with HIV
A National Institutes of Health (NIH) clinical trial was stopped early because planned interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study found that participants with HIV who took pitavastatin calcium, a daily statin, lowered their risk of major adverse cardiovascular events by 35% compared with those receiving a placebo. REPRIEVE began in 2015 and enrolled over 7,700 volunteers who were all taking antiretroviral therapy, with CD4+ cell counts greater than 100 cells/mm3 of blood at enrollment and had low-to-moderate traditional cardiovascular disease risk that would not typically be considered for statin treatment. Premature heart disease and other chronic conditions have emerged as leading causes of morbidity and mortality in people with HIV, contributing to persistent gaps in lifespan between people with HIV and the broader population. New data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV. The study’s Data Safety and Monitoring Board (DSMB) determined that the benefits of daily pitavastatin use outweighed any risks and recommended that the study terminate early, and that a full data collection be conducted across sites for final analysis.