High response rates observed with novel therapy for HCV infection

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1. A single-tablet regimen of ledipasvir and sofosbuvir produced high rates of sustained virologic response among patients with chronic hepatitis C virus genotype 1 infection who had previously failed conventional interferon therapy. 

2. No patient discontinued therapy due to an adverse event. 

Evidence Rating Level: 1 (Excellent)      

Study Rundown: Since the introduction of antiviral therapy for patients with hepatitis C virus (HCV) infection became available 30 years ago, compliance and efficacy of such therapy has been a challenge for health care providers. Many of the conventional drugs available produce common side effects and contraindications that limit the therapeutic response that can be achieved. In this study, researchers introduced a new HCV NS5A inhibitor, ledipasvir, combined in a single-tablet dose with the nucleotide polymerase inhibitor, sofosbuvir. The drug was administered once daily to patients diagnosed with chronic HCV genotype 1 infection. The novel therapy can be given for a relatively short time period to achieve a pharmacological response; however, a significant barrier remains for the availability of these drugs – cost.

Click to read the study in NEJM

Click to read an accompanying editorial in NEJM

In-Depth [randomized controlled trial]: A total of 551 patients from 64 sites across the United States underwent initial recruitment, with 440 eventually being administered treatment in this open-label study. These patients were above the age of 18 with chronic HCV infection and had not had a sustained virologic response to conventional interferon therapy.

The two drugs were given as an oral dose in a single tablet. Patients were randomized to one of four treatment groups: ledipasvir-sofosbuvir for 12 weeks, ledipasvir-sofosbuvir plus ribavarin for 12 weeks, ledipasvir-sofosbuvir for 24 weeks, or lesipasvir-sofosbuvir plus ribavarin for 24 weeks. Among these groups, the rates of sustained virologic response at 12 weeks after the end of therapy were 94% (95% CI, 87 to 97), 96% (95% CI, 91 to 99), 99% (95% CI, 95 to 100), and 99% (95% CI, 95 to 100), respectively. The majority of the patients in each treatment group encountered sides effects that were largely mild to moderate in severity.

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