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EASL 2013: 12 Weeks of Telaprevir Triple Therapy Adequate for Some Hep C Patients

Nearly 90% of genotype 1 chronic hepatitis C patients with favorable response factors including the IL28B CC gene variant achieved a cure with just 12 weeks of telaprevir (Incicek or Incivo) plus pegylated interferon/ribavirin, rising to 97% for those treated for 24 weeks, researchers reported at the recent EASL International Liver Congress (EASL 2013) in Amsterdam.

The advent of direct-acting antivirals has led to a paradigm shift in hepatitis C therapy. The current standard of care adds the HCV protease inhibitors boceprevir (Victrelis) or telaprevir to pegylated interferon plus weight-based ribavirin, with treatment continuing for 24 to 48 weeks.

But the new drugs add toxicities to the already difficult side effects of interferon, so shorter treatment is desirable. A variety of host and viral factors can help predict which patients will respond well to therapy and may be cured with a shorter course.

David Nelson from the University of Florida College of Medicine and colleagues compared treatment durations of telaprevir triple therapy among previously untreated hepatitis C patients and prior relapsers after a prior course of interferon-based dual therapy.

The Phase 3b CONCISE study included 239 genotype 1 chronic hepatitis C patients with the favorable IL28B CC gene pattern associated with good interferon responsiveness; 14% were treatment-naive, the rest prior relapsers. About 65% were men, most were white, and the mean age was 46 years. About 65% had harder-to-treat HCV subtype 1a. They did not have liver cirrhosis.

Participantswere treated with 1125 mg twice-daily telaprevir (the usual standard dose is 750 mg 3 times daily) plus pegylated interferon alfa-2a (Pegasys) and 1000-1200 mg/day weight-based ribavirin.

Those with rapid virological response (RVR) -- or undetectable HCV RNA at week 4 -- who continued all study drugs through week 12 were randomly assigned (2:1) either to stop all treatment at that point or to continue pegylated interferon/ribavirin alone for an additional 12 weeks (24 weeks total). People who were not randomized continued therapy for 24 or 48 weeks depending on early virological response.

Results 

• 159 participants, or 99%, had extended RVR and were eligible for randomization.
• 87% of patients who stopped all treatment at week 12 achieved sustained virological response 12 weeks after completing treatment (SVR12).
• 97% of patients who received treatment for 24 total weeks achieved SVR12.
• 8% of people treated for 12 weeks experienced viral relapse, compared with none in the 24-week arm.
• Triple therapy was generally safe and well-tolerated, with no unexpected adverse events based on prior studies.
• 7% of patients experienced serious adverse events -- mainly anemia -- during the 12 weeks of triple therapy.
• 13% discontinued treatment before week 12 due to adverse events.
• The most common adverse events during the telaprevir treatment phase were fatigue (48%), nausea (47%), anemia (41%), itching (34%), headache (26%), and rash (26%).

"High SVR rates from the CONCISE study interim analysis suggest the potential for the defined IL28B CC patients with RVR to shorten duration of telaprevir plus peginterferon/ribavirin to 12 weeks," the researchers concluded. "The safety profile is similar to that seen in previous clinical trials with telaprevir combination treatment."

6/13/13

Reference

DR Nelson, F Poordad, JJ Feld, et al. High SVR rates (SVR4) for 12-week total telaprevir combination therapy in IL28b cc treatment-naives and prior relapsers with G1 chronic hepatitis C: CONCISE interim analysis. 48th Annual Meeting of the European Association for the Study of the Liver (EASL 2013). Amsterdam. April 24-28, 2013. Abstract 881.

Other Source

Vertex Pharmaceuticals. Vertex Announces New Data that Showed High Viral Cure Rates with a Total of 12 and 24 Weeks of Telaprevir Combination Treatment Among People with Genotype 1 Hepatitis C Who Have the IL28B CC Genotype. Press release. April 24, 2013.