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Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial
Eric Lawitz1, Fred Poordad1, Julio A Gutierrez1
1Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
Hepatology (Baltimore, Md.)
|October 23, 2016
Summary
Shortening hepatitis C virus (HCV) treatment to 8 weeks with elbasvir/grazoprevir and sofosbuvir shows high efficacy across multiple genotypes. This regimen offers an effective option for HCV treatment, including retreatment for those who relapse.
Area of Science:
- Hepatology
- Virology
- Infectious Diseases
Background:
- Direct-acting antiviral agents (DAAs) are standard for hepatitis C virus (HCV) infection.
- Combining DAAs with different mechanisms may shorten treatment duration.
- Identifying minimum effective treatment duration across genotypes is crucial.
Purpose of the Study:
- To determine the minimum effective treatment duration for HCV genotypes 1 and 3 using a specific DAA combination.
- To evaluate treatment efficacy and safety in treatment-naïve patients.
Main Methods:
- Open-label, single-center trial (C-SWIFT) involving treatment-naïve patients with chronic HCV GT1 or 3.
- Patients received elbasvir (EBR) 50 mg/grazoprevir (GZR) 100 mg with sofosbuvir (SOF) 400 mg for 4-12 weeks.
- Sustained virological response (SVR)12 was the primary endpoint; retreatment was offered for treatment failures.
Main Results:
- High SVR12 rates were observed with 8-week regimens, even for HCV GT3 patients.
- For GT1 patients without cirrhosis, 6-week treatment yielded 87% SVR12.
- For GT3 patients without cirrhosis, 8-week treatment achieved 93% SVR12, and 12-week treatment achieved 100% SVR12.
Conclusions:
- An 8-week treatment regimen with EBR/GZR+SOF demonstrates high efficacy for HCV GT1 and GT3 infections.
- Retreatment for treatment failures involved extended duration and ribavirin, achieving SVR12 in all patients.
- The findings support shorter, effective treatment durations for HCV infection.
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