HIV and ID Observations

June 27th, 2013

Testing Out the New Website with an ID Link-o-Rama

Hey, new website is live! Interested to hear what you think about our new-ish look. In celebration, here are some quick ID/HIV tidbits that have recently crossed my path, or have been sitting in my inbox for a while, dying to get out: Doxycycline shortage. Hardly anything more frightening to a New England ID doc than a shortage […]

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June 20th, 2013

Let’s Move the HIV Testing Algorithm Into the 21st Century

As I’ve written before, the most widely used testing algorithm for HIV — enzyme immunoassay followed, if positive, by Western blot confirmation — is long overdue for an update. A brief review why this is the case, and also why sticking with it is so problematic: Immunoassays have become progressively more sensitive, especially when paired with p24 […]

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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. […]

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June 13th, 2013

PrEP Works in Injection Drug Users, CDC Offers “Guidance”

From The Lancet comes this important study of tenofovir pre-exposure prophylaxis for injection drug users (IDUs): In this randomised, double-blind, placebo-controlled trial, we enrolled volunteers from 17 drug-treatment clinics in Bangkok, Thailand … We randomly assigned [2413] participants to either tenofovir or placebo … 50 became infected during follow-up: 17 in the tenofovir group and 33 […]

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June 11th, 2013

Both Simeprevir and Sofosbuvir Likely Approved by 2014 — Clinical/Ethical/Pharmacoeconomic Dilemmas Loom

As expected, simeprevir, and now also sofosbuvir, are being given “priority review” by the FDA. With the 6-month rule under the Prescription Drug User Fee Act — usually just said as “pah-DOOF-ah” — that means there’s a good chance we’ll have both of these anti-HCV drugs some time in late 2013. Which also means HCV treaters will soon […]

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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 […]

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May 2nd, 2013

How to Interpret Medical Breakthroughs in the Mainstream Media

There it is, right in your daily paper, on your tablet or computer screen, or wherever you get your news today — a headline about a great medical breakthrough everyone’s been waiting for: Scientists on brink of HIV cure Researchers believe that there will be a breakthrough in finding a cure for HIV “within months” Yes, […]

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April 10th, 2013

Simeprevir and Sofosbuvir Submitted to FDA — Clock Ticking on Boceprevir, Telaprevir, Even Interferon

Two weeks, two companies, two press releases, two future HCV drugs that begin with “S”: March 28, 2013: Janssen Research & Development announced that it has submitted a New Drug Application to the FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the […]

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April 5th, 2013

Another “Important Advance” in HIV Vaccine Research?

On reading this other real news about a single patient and how it may shape the future of HIV vaccine research, I decided to write the following fake news, drawing liberally on many similar stories over the years: Scientists today reported a discovery that could finally pave the way for an effective AIDS vaccine. In the study, published […]

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April 2nd, 2013

Banner Day for ID on Physician’s First Watch, and a Big Pitch to Sign Up Now

Every weekday morning, right around the time the rest of my family gets up, the smart people at Physician’s First Watch send me an email listing the top medical news stories of the day. Imagine my delight yesterday when the following were deemed worthy for specific mention: Coccidioidomycosis! Valley fever cases on the rise in the USA. You […]

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