- A 6-week regimen of sofosbuvir-velpatasvir (Epclusa) for treatment of acute hepatitis C (HCV) infection appears to be inferior to a standard 12-week course according to research presented at last week’s Conference on Retroviruses & Opportunistic Infections (CROI – 2020).
Why this matters
- This is the first randomised clinical trial to determine if a shorter duration of a direct-acting antiviral was efficacious against HCV, which would provide a more convenient and cost-effective strategy for clinicians and patients alike.
- 185 patients enrolled, 165 randomised; 98% male, 72% HIV-positive, median age 43 years.
- 65% had HCV genotype 1, median baseline viral load=5.6 log10 IU/ml; 38% reinfections.
- Relapse: 9.7% (93) vs 2% (99), short, standard arms, respectively.
- Median baseline viral load=6.4 log10IU/ml.
- Adherence: >95% in all but 1 patient randomised to 12 weeks.
- 6-week: 18.3% (17) treatment failures, including 2 deaths, 3 reinfections, 3 lost to follow up, 9 relapses from 12 weeks to end of treatment.
- Corresponding values, 12 week: 8% (8) treatment failures, 2 reinfections, 2 lost to follow up, 2 relapses, no deaths.
- After excluding patients with no virological explanation for failure, viral RNA was undetectable in 98% vs 89%, 12-week, 6-week patient arms, respectively.
- Open-label, randomised, phase 4 non-inferiority study comparing short (6 week) vs standard course (12 week) sofosbuvir-velpatasvir for treatment of recently-acquired HCV infection in HIV-infected adults.
- Funding: National Institutes of Health.
- Study halted due to ineffectiveness.
- “In the end, 6 weeks of sofosbuvir-velpatasvir was inferior to 12 weeks,” said investigators led by Dr Gail Matthews, Associate Professor in the Viral Hepatitis Clinical Research Program at Kirby University in Sydney, NSW Australia. Dr Matthews added that there were not treatment-related discontinuations and that all relapsed patients were successfully treated with subsequent therapy.