An ongoing dialogue on HIV/AIDS, infectious diseases,
November 27th, 2013
Gynecologists May Treat Men After All
Good news here for gynecologists who screen men for anal cancer: A professional group that certifies obstetrician-gynecologists reversed an earlier directive and said on Tuesday that its members were permitted to treat male patients for sexually transmitted infections and to screen men for anal cancer… It’s always impressive when a group swiftly reverses what is widely perceived […]
October 30th, 2013
HIV Treatment of Serodiscordant Couples: The Home Run, Slam Dunk, and Open Goal in Clinical Research
Just in time for Game 6 of the World Series, my colleague Rochelle Walensky has published a paper in theNew England Journal of Medicine (covered here in NEJM Journal Watch). evaluating the cost-effectiveness of treating HIV-infected individuals in serodiscordant couples. The results: In South Africa, early ART was cost-saving over a 5-year period. In both South Africa and India, early […]
September 27th, 2013
Yes! An Economic Justification for ID Specialists
We’re currently in the middle of fellowship interview season, and I overheard the following conversation between two of my colleagues as they contemplated their upcoming interviewees: ID Doctor #1: He seems like a great candidate — wants to study hospital and community epidemiology of highly drug-resistant bacterial infections, and has already made major contributions to his […]
August 28th, 2013
Poll: At $14,105/year, Is Dolutegravir Fairly Priced?
The recently approved once-daily integrase inhibitor dolutegravir is now in pharmacies and, like every new HIV drug, the price — around $14k/year — has generated some controversy. For the record, here are the per-year wholesale acquisition costs of the three FDA-approved integrase inhibitors. Raltegravir: $12,976 Elvitegravir: $13,428 (once disentangled from the price of TDF/FTC) Dolutegravir: $14,105 If […]
August 7th, 2013
Occupational Post-Exposure Prophylaxis (PEP) Guidelines Updated — And They Are Clear and Sensible
Good news here — the United States Public Health Service has issued new national guidelines for management of occupational exposure to HIV. Authored by an expert panel, these updated occupational PEP guidelines replace the (woefully outdated, sorry, had to write that) previous version, which dates back to 2005. On a quick read-through, despite the density of print, the […]
June 19th, 2013
FDA, IND, FMT: Nine Letters, Some Common Sense, and a Real Video Link
Good news here — the FDA has reconsidered their requirement for an IND for fecal microbiota transplantation (FMT) for C diff: Some health care providers have stated that applying IND requirements will make FMT unavailable and have suggested that an alternative regulatory approach is needed to ensure the widespread availability of FMT for individuals with C. […]
May 31st, 2013
Fecal Microbiota Transplantation — Try This At Home?
As noted before, the FDA says that an investigational new drug (IND) application is required for therapeutic use of fecal microbiota transplantation. The practical effect of this decision, at least at our institution, is to stop providing this service — it’s on hold pending those “internal discussions” planned by the FDA on the regulatory issues surrounding the procedure. Which […]
May 29th, 2013
The New SARS-Like Coronavirus (MERS-CoV), and What To Do When You Don’t Know Anything About The Latest Outbreak
From one of my close friends — a non-MD — comes this alarming video (sorry, can’t remove the preceding ad). And here’s his email: Concerned? Terrified? I bet your department is buzzing about this. Um, not quite — especially since, among the 49 cases in the world (apparently there are 5 more than the WHO reported), exactly zero […]
May 12th, 2013
FDA: Fecal Transplants Need Investigational New Drug Application
Gastroenterologists, ID doctors, C diff-sufferers, and microbiome-obsessed humanoids everywhere were treated to this surprising news recently — a decision by the FDA about fecal microbiota transplantation (FMT). From an email sent by the IDSA: Because fecal microbiota transplantation (FMT) is not approved for any therapeutic purposes, an investigational new drug (IND) application is needed for the […]
May 8th, 2013
HIV Opportunistic Infection Guidelines Updated
Some very hard-working folks at the NIH, CDC, and IDSA have updated the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, which are available for review here. As with the previous versions (the prior iteration is from 2009), the OI Guidelines are comprehensive, exhaustively referenced (184 references for TB alone!), […]