HIV and ID Observations

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 transatlantic […]

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December 8th, 2013

Simeprevir and (Especially) Sofosbuvir Are Great Leaps Forward — and They Will Cost Plenty

Hepatitis C has been potentially curable for decades, but it’s hardly been easy. “I feel like I’m slowly killing myself,” said one of my patients, memorably, during week 24 of a planned bazillion-week course of interferon-ribavirin. (Actually it was only 48 weeks, but seemed like a bazillion weeks.) Then in 2011 came the addition of telaprevir […]

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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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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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August 6th, 2017

Have We Reached the End of HCV Drug Development?

Two new HCV regimens gained FDA approval recently, bringing us closer to the end of this extraordinary phase of drug development. Think about it — has there ever been a more spectacularly rapid improvement in treatment of anything? If so, please let me know what that is. Remember, as recently as early 2013, highly toxic interferon-based therapy (with ribavirin and telaprevir […]

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January 29th, 2016

Elbasvir/Grazoprevir Combination Pill for HCV a Welcome New Option — With a Few Buts

As expected, there’s a new option for HCV therapy, the combination pill elbasvir/grazoprevir (EBR/GZR, brand name Zepatier, more on this below), and it’s indicated for genotypes 1 and 4. For those mechanistically inclined, elbasvir is an NS5A inhibitor (like ledipasvir), and grazoprevir is a protease inhibitor (like simeprevir). This is the second one-pill, once a day option […]

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July 26th, 2015

Really Rapid Review — IAS 2015, Vancouver

Vancouver will always have a special place in HIV treatment history. It was here, in 1996, that many of us first saw the potential of combination antiretroviral therapy to control this disease. Specifically, Study 035 of AZT, 3TC, and indinavir (presented by Trip Gulick) demonstrated the astounding finding that triple therapy induced sustained virologic suppression and dramatic immunologic improvement. Could it be that not everyone […]

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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 […]

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November 23rd, 2014

Five ID/HIV Things to be Grateful for this Holiday Season, 2014 Edition

Amidst outbreak hysterias, anti-vaccine imbecility, electronic medical record whining, and slug-related eosinophilia, I bring you this year’s version of the good news — the 2014 edition of Five ID/HIV Things to be Grateful for this Holiday Season, just in time for your holiday turkeys. (Needless to say, the bird will be properly cooked to ensure it’s salmonella-free, with all cooking […]

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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 […]

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