Posts Tagged ‘sofosbuvir’

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July 3rd, 2016

Velpatasvir/Sofosbuvir Makes HCV Treatment Simpler, Especially For Genotypes 2 and 3

One of the ways ID and hepatology hepatitis C experts like to show off is by discoursing on the nuances of cleverly named clinical trials, and how these impact treatment guidelines. It usually goes something like this: “In the EP-CILEON [I made that up] study of [insert HCV regimen here], treatment-experienced patients with genotype [insert non-genotype 1 patients here, […]


November 18th, 2015

Are There Remaining Challenges in HCV Therapy?

Prompted by (yet more) spectacular HCV study results, I posted the following questions on Twitter: Is velpatasvir/sofosbuvir the endgame for HCV? And what will HCV researchers do now? https://t.co/vL2A9FOttR @NEJM — Paul Sax (@PaulSaxMD) November 18, 2015 To which I got this reply from one of our very energetic second-year ID fellows: @PaulSaxMD @NEJM what about coinfected patients, […]


December 14th, 2014

2014 Top Stories in HIV Medicine

Boy do we love end-of-year “Best of …” and “Top Stories of …” lists! Love them! They never gets old! Until January, that is. My own particular favorites are the Best Movies of the Year lists, since for whatever reason it always seems like some masterpiece slips by. Missed it! So we leave it up to the […]


October 12th, 2014

Approval of Sofosbuvir/Ledipasvir Was Expected, but Still Is a Huge Advance

As expected, the FDA just approved the first single-pill treatment for hepatitis C genotype 1, a tablet containing 400 mg of sofosbuvir (SOF) and 90 mg of ledipasvir (LDV). For those not following this story closely, sofosbuvir is the pan-genotypic NRTI polymerase inhibitor approved last December to much rejoicing — and controversy about the price. Ledipasvir […]


April 12th, 2014

Unwittingly, HCV “News” Brackets Our Current Treatment Era on Successive Days

I’ve already told you what a fan I am of Physician’s First Watch, the daily email summary of hot medical news provided by my colleagues here at the Massachusetts Medical Society. If you haven’t signed up, you must do so — let’s play a short tune (always a favorite) for background music while you head over […]


March 29th, 2014

Opening Day ID Link-o-Rama

Several ID/HIV tidbits to keep you entertained until Sunday night’s opening “day” — for baseball that is. (I hear there’s some sort of basketball tournament going on as well.) Away we go! Female-to-female sexual transmission of HIV is extremely uncommon — though one such case was diagnosed at our hospital over 20 years ago — but this most recent report from Texas […]


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 […]


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 […]


HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

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