Big Interferon-free Hepatitis C Study

Every week there is more information on clinical trials for hepatitis C; I am waiting for this to translate into improvements for the pediatric population.

This week’s biggest publication: NEJM 2013; 369: 630-9.  This was a phase 2b randomized open-label trial of faldaprevir (a NS3/4A protease inhibitor) in combination with deleobuvir (a non nucleoside NS5B polymerase inhibitor).  In total, 5 different regimens were examined, most in combination with ribavirin.  The authors recruited 362 HCV genotype 1 patients who were randomized into these treatment groups & he sustained virologic response 12 weeks after completion of therapy

  • Faldaprevir 120 daily, deleobuvir 600 three times a day, and ribavirin for 16 weeks (TID16W) –>59%
  • Faldaprevir 120 daily, deleobuvir 600 three times a day, and ribavirin for 28 weeks (TID28W) –>59%
  • Faldaprevir 120 daily, deleobuvir 600 three times a day, and ribavirin for 40 weeks (TID40W) –>52%
  • Faldaprevir 120 daily, deleobuvir 600 two times a day, and ribavirin for 28 weeks (BID28W) –>69%
  • Faldaprevir 120 daily, deleobuvir 600 three times a day, without ribavirin for 28 weeks  (TID28W-NR) –>39%

Rates of SVR were higher among genotype 1b, 56-85%, compared with 1a, 38-43% (when excluding non-ribavirin group).  Genotype 1a patients with IL28B CC had similar response (58-84%) to genotype 1b patients.  Genotype 1a patients were much more likely to relapse if not treated for at least 28 weeks.

Adverse effects were common and reported in 94% of participants; 9% had severe adverse reactions.  Gastrointestinal and dermatologic advents events were the most frequent.  Also, faldaprevir resulted in jaundice (unconjugated hyperbilirubinemia) in many patients (16-28% of patients who took ribavirin in their regimens).

This large study showed that when these oral antiviral are used in combination with ribavirin that results are similar to current standard of care treatments for adult patients.  For telaprevir or boceprevir, along with pegylated interferon and ribavirin, phase 3 trials showed SVRs between 68-75%.

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