Sofosbuvir-Based Regimen for HCV Relapse After Sofosbuvir plus Ribavirin

November 6, 2014

Sofosbuvir-Based Regimen for HCV Relapse After Sofosbuvir plus Ribavirin

  1. Atif Zaman, MD, MPH

Sofosbuvir plus ledipasvir had 100% efficacy in a small, difficult-to-treat patient population.

  1. Atif Zaman, MD, MPH

A 24-week regimen of sofosbuvir and ribavirin (SOF/RBV) is FDA-approved for the treatment of hepatitis C virus (HCV) genotype 1 infection in patients who are ineligible for or intolerant of interferon. Although this regimen is effective, relapse occurs in 15% to 30% of patients. The next generation of HCV genotype 1 regimens such as sofosbuvir/ledipasvir (SOF/LDV) has recently become FDA-approved (Physician's First Watch Oct 14 2014), but it is unknown whether this regimen will be effective in patients who experience relapse after SOF/RBV therapy.

In an ongoing, industry-supported, open-label, phase IIA study, 14 patients with HCV genotype 1 infection with previous relapse after 24 weeks of treatment with SOF/RBV were treated with SOF (400 mg) and LDV (90 mg) in a single pill daily for 12 weeks. The primary endpoint was sustained virologic response 12 weeks after treatment ended (SVR12).

The cohort had high frequencies of factors traditionally predictive of poor response, such as advanced fibrosis (50% were stages 3–4), black race (93%), and IL28B genotype of CT or TT (86%). In addition, prior to treatment, one patient had detectable S282T mutation, which confers resistance to sofosbuvir. However, all 14 patients had undetectable viral loads at weeks 4 and 12 and achieved SVR12. No treatment discontinuation or grade 4 adverse events occurred.

Comment

This study is the first to evaluate the use of an alternative interferon-free therapy in HCV-infected patients who have relapsed after taking a direct-acting antiviral regimen without interferon. Despite this patient group's difficult-to-treat profile, the response rate with SOF/LDV was 100%. These results are striking but need to be validated in larger studies. These preliminary results offer hope that soon the ability to eradicate HCV infection will be universal.

Editor Disclosures at Time of Publication

  • Disclosures for Atif Zaman, MD, MPH at time of publication Nothing to disclose

Citation(s):

Reader Comments (1)

Cesar Salazar Physician, Gastroenterology, solo practice

I thougth that S282T mutation confer resistant to Simeprevir instead of Sofosbuvir

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