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Posts Tagged ‘HCV’

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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 […]


September 7th, 2014

It’s OK to Limit Who Prescribes HCV Therapy, but Insurers Shouldn’t Be Deciding

Some insurers would like to limit the prescribing of HCV treatment to gastroenterologists, hepatologists, or infectious diseases specialists. Not surprisingly, this doesn’t sit well with either the HIV Medicine Association (HIVMA) or the American Academy of HIV Medicine (AAHIVM), both of which have long acknowledged that some of the most seasoned HIV providers are generalists: “There is no […]


July 31st, 2014

Simeprevir, Sofosbuvir, and the Limitations of the COSMOS

These are exciting times for hepatitis C treatment, as the approval of simeprevir and sofosbuvir in late 2013 have made curing this disease a whole lot easier. Since that sentence barely conveys the transformative nature of this medical advance, allow me this tortured analogy: Before simeprevir and sofosbuvir, curing hepatitis C was like making a […]


July 30th, 2014

Hepatitis Day “Celebration” and a Reminder

July 28 is “World Hepatitis Day” (how do they choose the dates for these things?), and I wrote a bit over on the Oxford University Press site on the incredible progress we’ve made already — with more to come. Definitely plenty of reasons to celebrate — safe and effective immunizations for hepatitis A and B, […]


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 […]


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 […]


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 […]


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 […]


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 […]


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 […]


HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

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