Wednesday, December 11, 2013

Best treatment options for HCV genotype 1: All of them contain sofosbuvir, all are expensive

December 8th, 2013
HIV and ID Observations

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

Paul E. Sax, MD

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 or boceprevir to the interferon-ribavirin, which made a cure more likely, but the treatment even worse. Rashes. Need for fatty meals. Tons of pills. Taste disturbance. Anal discomfort. (“Like shitting glass,” another memorable quote.) Anemia. And for the providers, having to manage these side effects and the complex “response-guided therapy” algorithms was no picnic.

Now, with the approval of simeprevir in November and in particular sofosbuvir Friday, HCV cure just got a whole lot easier. Both are one pill a day. Both have far fewer side effects than any existing HCV drug. Sofosbuvir adds the benefit of having almost zero important drug-drug interactions. (Simeprevir has many.)

The main problem with these new treatments is, frankly, their cost. They are very expensive — 12 weeks of simeprevir will be $65,000, of sofosbuvir $80,000. These costs are offset somewhat by reduced need for monitoring with safer therapies, a shorter course of interferon and ribavirin (if you go that route), and presumably down the road, prevented cases of cirrhosis, hepatocellular carcinoma, and liver transplantation.

And of course, few individuals will actually pay full price out of pocket for these treatments, just like few actually pay for their MRIs or their angioplasties or their stay in the ICU. Treating HCV is not like cosmetic surgery; it’s potentially lifesaving. And as with other expensive but lifesaving treatments, we’re hoping there will be generous patient-assistance programs for those who can’t pay.

But for those without coverage, people in other countries, or those charged with managing pharmacy budgets, this cost is a major hurdle.

All of which leaves me thinking that as of December 8, 2013, these are the best options for genotype 1 HCV infection (cost estimates approximate):

1. Simeprevir + sofosbuvir for 12 weeks.

PROS: More than 90% cure rate in the COSMOS study.

Two pills once daily (it’s amazing even to write that.)

CONS: The COSMOS study was very small. Simeprevir can lead to photosensitivity and has many drug-drug interactions. The Q80K polymorphism may reduce response to simeprevir.

This regimen is not “FDA approved.” Cost = $145,000.

2. Sofosbuvir + ribavirin for 24 weeks.

PROS: Cured 76% of HIV/HCV co-infected patients in the PHOTON-1 study. May well do better in HCV mono-infected. Regimen is “FDA approved” for interferon-ineligible patients, which could help get insurance coverage.

CONS. Ribavirin, and all its side effects. 24 weeks seems long compared to 12 weeks. Response rate is lower than other options listed here, which would require re-treatment.

Cost (not including ribavirin) = $160,000.

3. Sofosbuvir + interferon + ribavirin for 12 weeks:

PROS: 90% cure rate in the NEUTRINO study. Only 12 weeks of interferon and ribavirin.

Cost = $90,000. CONS: Interferon. Ribavirin. Enough said.

All are a lot better than what we had just last week. All of them contain sofosbuvir. And all are expensive.

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