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Take Home Points from the 2013 Liver Meeting

GoodSummarizing last week’s annual Liver Meeting is like telling one of those good news/bad news stories. In this post, I’ll begin with the “good news.” The “bad news” will be in the next post.

My Favorite News

Direct-acting antivirals (DAAs) are changing the landscape of hepatitis C treatment. The good news is plentiful—short, effective all-oral treatments, with low side effect profiles. In general, the news is improving for hard-to-treat populations. This includes HIV/HCV coinfected patients as well as those with cirrhosis. In short, DAAs seem to offer hope for everyone.

The big news was the data provided from the SYNERGY study showing that these treatments may be equally effective for African-Americans. Because of host DNA characteristics, interferon is ineffective for some, particularly African Americans. DAAs are a game changer. Note: my DNA has this interferon-resistant variation, and like the rest of life, the color of someone’s skin is a meaningless predictor of anything.

This meeting was the first time a study showed that an all-oral, treatment prevents recurrence of hepatitis C in patients who received liver transplants. Hepatitis C recurrence is universal following liver transplantation of recipients who had detectable virus at the time of the surgery. Interferon treatment is poorly tolerated and yields low response rates for hepatitis C recurrence prevention. In this small phase 2 study of 39 patients, approximately 64% were able to clear hepatitis C.

Another exciting development is that it is looking like the 12-week post-treatment mark (SVR-12) is as strong as the 24-week mark (SVR-24). This means shorter waiting times for final results.

Good News regarding New Hepatitis C Drugs

Studies revealed higher hepatitis C cure rates for patients with HIV/HCV coinfection using all-oral treatments. In a phase 3 study, patients were treated with sofosbuvir (one pill daily) and ribavirin (pills twice daily) for 12 or 24 weeks.

  • Genotype 1 patients with no prior treatment had a response rate of 76% when treated for 24 weeks.
  • Genotype 2 patients with no prior treatment had a response rate of 88% when treated for 12 weeks.
  • Genotype 3 patients with no prior treatment had a response rate of 67% when treated for 12 weeks.
  • Drugs were well tolerated and the side effects were mainly associated with ribavirin—fatigue, nausea, headache and insomnia.

Hepatitis C treatments in the drug pipeline are pushing the envelope and redefining the meaning of success. (For drugs the FDA is considering, see Simple Talk about Future Hepatitis C Treatments.) Two drugs that the FDA is considering are sofosbuvir and simeprevir. Although the FDA is not considering these together, a study using these two drugs yielded 93% response rates 12 weeks after treatment.

In addition to the drugs that are awaiting FDA approval, other hepatitis C drugs are nipping at their heels. Although there are quite a few all-oral regimens, here are some top contenders:

  • Gilead’s sofosbuvir with ledipasvir yielded 70% cure rates, which jumped to 100% when either ribavirin or GS 9669 were added.
  • AbbVie’s phase two studies had responses ranging from 90% to 95% in genotype 1 patients.
  • Merck’s ranged from 96% to 100%. Treatments durations varied, but 12 weeks looks like a feasible treatment length.

Other all-oral hepatitis C treatments worth noting:

A small study presented by Gregory Everson – Genotype 1 patients using daclatasvir, asunaprevir, and BMS 791315 for 12 weeks had 90%-to 100% results. Oddly, the arm of patients with cirrhosis was 100%, but this is a small study.

Possible good news regarding Gilead’s sofosbuvir and ribavirin for genotype 3 patients: When the original phase 3 study data were released, genotype 3 response rates were sub-optimal. Data from a new phase 3 study (VALENCE) revealed that 24 weeks of treatment for genotype 3 patients had better results:

  • 94% in treatment-naïve non-cirrhotic patients
  • 92% in treatment-naïve cirrhotic patients
  • 87% in treatment-experienced non-cirrhotic patients
  • 60% in treatment-experienced cirrhotic patients

In my next post, I will talk about the “bad news”…

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