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Hepatitis C Treatment: Proceed Now or Wait?

Talk to Your Doctor about New Hepatitis C Treatments

Talk to Your Doctor about New Hepatitis C Treatments

The question that hepatitis C patients ask me the most is, “Should I go ahead and do treatment now with the new drugs, or should I wait for interferon/ribavirin-free regimens?” My answer is that I cannot give medical advice, and that you need to discuss this with your doctor. However, I can give you some information that may help you as you make your decision.

A few months ago, two new hepatitis C treatments were approved by the FDASovaldi and Olysio. Sovaldi’s approval was especially momentous since it was the first all-oral hepatitis C treatment to be approved, in this case for patients who have genotype 2 or 3 or who can’t take interferon. Sovaldi has a higher cure rate and shorter treatment length than Olysio. It also has a higher price tag, but many insurance plans are covering the cost.

For simplicity’s sake, I will discuss options using Sovaldi for genotype 1 hepatitis C patients who have had no prior treatment. For this group of patients who are able to take pegylated interferon, the American Association for the Study of Liver Diseases and the Infectious Diseases Society’s Recommendations for Testing, Managing, and Treating Hepatitis C advise 12 weeks of treatment using weekly pegylated interferon, daily sofosbuvir (Sovaldi), and weight-based ribavirin.  The sustained virologic response rate (SVR or virologic cure) is 89%. Compared to previous hepatitis C treatments, this regimen is easier to tolerate and has a better response rate. In short, it is a vast improvement.

However, just ahead are even better treatments, assuming that they approved, which I have every reason to believe. On February 10, 2014, Gilead announced that it submitted an application to the FDA for approval of ledipasvir/sofosbuvir, a combined pill to treat genotype 1 hepatitis C. Patients with genotype 1 hepatitis C had a 93-99% chance of a virologic cure with 8 to 12 weeks of ledipasvir/sofosbuvir, depending on prior treatment history and whether they have cirrhosis. This is WITHOUT interferon or ribavirin. Ledipasvir/sofosbuvir is generally well tolerated with mostly mild side effects (fatigue/headache).

AbbVie is just behind Gilead in getting its hepatitis C drug regimen to market. Also expected to launch at the end of 2014, the AbbVie regimen will also be interferon/ribavirin free, and for genotype 1 patients. The response rates are 99% with similar, tolerable side effects. The downside of AbbVie’s regimen (ABT-267, ABT-333 and ABT-450/ritonavir) is that it requires multiple pills per day. However, perhaps AbbVie will set a more reasonable price point.

And it just keeps getting better. At the recent 2014 Conference on Retroviruses and Opportunistic Infections, results of a small study (SYNGERY) using sofosbuvir, ledipasvir, and a 3rd drug (either GS-9669 or GS-9451) yielded 95%  to 100%  SVR-12 rates with just SIX WEEKS of treatment and mild to moderate side effects. I don’t know when this regimen will available, but I’d start looking for it in 2015.

Anxious to get started but wanting to avoid peginterferon, some doctors are prescribing sofosbuvir plus weight-based ribavirin. These studies used small numbers of subjects, and the data vary dramatically. Adding them together for a total of 211 subjects, SVR for 12 and 24 weeks of treatment for genotype 1 patients ranged from 47% to 90%, with an overall SVR of 72%. Those with cirrhosis had the lowest SVRs.

For those needing immediate treatment, physicians are trying another route—sofosbuvir plus simeprevir. Without ribavirin, preliminary SVR rates for genotype 1, treatment-naïve patients were 93% for 12 weeks of treatment.

For so many years, the question for genotype 1 hepatitis C patients was whether to endure severe side effects with no guarantee of a cure. Now the issue is, whether to put up with a shorter length of time with side effects and nearly 90% chance of clearing hepatitis C, or wait a short time for even better treatments. As I said in the beginning, talk to your doctor.

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  • Lilly May 16, 2014, 1:44 PM

    Could you comment on the chances of approval of these new drugs?

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