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Progress Toward All-Oral, Interferon-Free Therapy for HCV Genotype 1 Infection

January 15, 2014

Progress Toward All-Oral, Interferon-Free Therapy for HCV Genotype 1 Infection

  1. Atif Zaman, MD, MPH

Regimens tested in open-label studies achieved high virologic response with low resistance and few adverse effects.

  1. Atif Zaman, MD, MPH

Interferon is still currently required for treating hepatitis C virus (HCV) genotype 1 infection. Now, investigators report findings of two new studies evaluating interferon-free regimens for these patients.

In an open-label study, Sulkowski and colleagues evaluated daclatasvir (an NS5A inhibitor; 60 mg daily) plus sofosbuvir (an NS5B inhibitor; 400 mg daily) with or without ribavirin for 24 weeks in patients with genotype 1 infection (44 treatment-naive and 41 treatment-experienced with telaprevir-based or boceprevir-based regimens). Another 82 treatment-naive patients received therapy for 12 weeks. Sustained virologic response (SVR) at 12 weeks posttreatment was 98% and did not vary by ribavirin use, HCV subtype, or IL28B genotype.

In a phase IIB study, Kowdley and colleagues randomized 571 patients with genotype 1 HCV infection without cirrhosis to receive ABT-450/r (the protease inhibitor ABT-450 plus 100 mg of ritonavir) in daily doses of 100 mg, 150 mg, or 200 mg with ABT-267 (an NS5A inhibitor; 25 mg daily) or ABT-333 (nonnucleoside polymerase inhibitor; 400 mg twice daily) or both for 8, 12, or 24 weeks. In addition, all but one of the subgroups received ribavirin (1000–1200 mg daily). Among patients receiving ABT-450/r plus ABT-267 or ABT-333 or both plus ribavirin, SVR rates at 24 weeks posttreatment ranged from 83% to 100% in treatment-naive and treatment-experienced patients. Rates were highest among patients receiving all three anti-virals plus ribavirin and those receiving 12 weeks of therapy (vs. 8 weeks). SVR varied significantly by HCV subtype, host IL28B haplotype, race, and baseline HCV RNA level.

In both studies, resistance was uncommon, and side effects were mild (e.g., fatigue, headache, nausea).

Comment

These two all-oral, direct-antiviral regimens for hepatitis C virus genotype 1 infection achieved high sustained virologic response rates with a short duration of therapy and low resistance and adverse effects. In addition, none of the traditional predictors of negative response had a significant effect on treatment response. Soon, all-oral regimens for every HCV-infected patient will be a reality.

  • Disclosures for Atif Zaman, MD, MPH at time of publication Speaker’s bureau Bristol-Myers Squibb; Genentech; Gilead; Kadmon; Merck; Salix; Vertex

Citation(s):

Reader Comments (2)

ahmed kabil Physician, Gastroenterology

what about genotype4?

Dr.M A KHAN Physician, Gastroenterology, Lrh

Valuable information....hope to see above Tx in reasonable cost in pakistan as soon

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