An ongoing dialogue on HIV/AIDS, infectious diseases,
December 20th, 2014
New HCV Option Effective, Safe, Well-Tolerated — And Use Will Likely Be Driven by Payors
As expected, the FDA approved the next treatment option for HCV on Friday — “Viekira Pak”, a (sometimes complete) regimen consisting of ritonavir-booted parataprevir and ombitasvir given as a two pills once a day, plus one pill of of dasabuvir given twice daily. It is indicated for treatment of HCV genotype 1. For those of you mechanistically inclined, parataprevir […]
April 23rd, 2013
Two Papers, Four Sofosbuvir Studies, and Soon the End of “Interferonologists”
Today, as the The International Liver Congress is about to start, two papers are published in the New England Journal of Medicine on sofosbuvir, the investigational anti-HCV nucleotide submitted to the FDA for approval earlier this month. Each paper actually includes within them two studies. (For some reason, all the studies sound like 1950s science fiction magazines.) […]
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 […]
October 16th, 2012
Some Liver Meeting “Wow!” Studies Start to Emerge
The Liver Meeting, the annual meeting of the American Association for the Study of Liver Disease, does not take place until November 9-13, in Boston. But if you want a preview, a couple of notable studies have already been “announced” in the press. Specifically, there’s this: Abbott today announced initial results from “Aviator,” a phase 2b study of its interferon-free, […]
November 9th, 2011
HCV Treatment Studies at AASLD: Wow … and I Mean WOW!
I didn’t attend “The Liver Meeting” (the nickname for the annual meeting of the American Association for the Study of Liver Diseases, AASLD), but the studies presented there this week on HCV treatment were absolutely mind-boggling. “Breathtaking!” said one of my HCV-oriented colleagues. “Hopeful is an understatement,” said another. An example: Dual Oral Combination Therapy with the NS5A […]
April 28th, 2011
Hepatitis C Week is Upon Us
After many — and I mean many — years of telling patients that new hepatitis C drugs were “coming soon,” that time has finally come. An FDA Advisory Panel yesterday favorably reviewed the HCV protease inhibitor boceprevir; today telaprevir got the same unanimous report. The FDA will certainly follow with approval for both drugs, and hence […]
Paul E. Sax, MD
Contributing Editor
NEJM Journal Watch
Infectious Diseases
Biography | Disclosures | Summaries
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