Drug updated on 9/4/2024
Dosage Form | Tablet (oral; sofosbuvir/velpatasvir: 400 mg/100 mg, 200 mg/50 mg); Pellet (oral; sofosbuvir/velpatasvir: 200 mg/50 mg, 150 mg/37.5 mg) |
Drug Class | HCV NS5A inhibitors and HCV nucleotide analog NS5B polymerase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
- For the treatment of adult and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection with decompensated cirrhosis in combination with ribavirin.
Latest News
Summary
- Epclusa (sofosbuvir and velpatasvir) is indicated for the treatment of adult and pediatric patients aged 3 years and older with chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, and for the treatment of adult and pediatric patients aged 3 years and older with chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection with decompensated cirrhosis, in combination with ribavirin.
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Sustained Virological Response (SVR12): SOF/VEL achieved SVR12 rates of 94.2% (95% CI: 90.7-97.7%) in the general population, 91.0% (95% CI: 87.7-93.9%) in decompensated cirrhosis, 97.69% (95% CI: 95.71-98.92%) in ESRD patients, and 95.08% (95% CI: 90.88-98.13%) in HCV genotype 3 patients.
- Comparison of SOF/VEL with Other Treatments: SOF/VEL demonstrated higher SVR12 rates compared to SOF/LED (86.3%, p=0.004) and SOF/DCV (82.4%, p<0.001) in patients with decompensated cirrhosis. SOF/VEL also outperformed SOF/VEL/VOX in HCV genotype 3 with SVR12 rates of 95.08% vs. 84.97% (95% CI: 73.32-93.91%).
- Subgroup Analysis: Adolescents treated with SOF/VEL showed a 95% SVR12 rate, older children 93%, and young children 83%. Decompensated cirrhosis patients had a 91.0% SVR12 rate, and ESRD patients on RRT had a 97.69% SVR12 rate.
- Sofosbuvir/Velpatasvir (SOF/VEL): Reported adverse events in 30% of patients, with serious adverse events in 3.82%. No serious adverse events attributable to SOF/VEL in patients with end-stage renal disease.
- SOF/VEL in Decompensated Cirrhosis: Adding ribavirin significantly increased the frequency of adverse events from 52.9% to 89.2%.
- Evaluations of specific population types, including adolescents, older children, young children, decompensated cirrhotic patients, patients with ESRD on RRT, and patients with HCV Genotype 3 and 6, indicate varying SVR12 rates and adverse events, with younger children showing higher AE rates and ribavirin increasing adverse events in decompensated cirrhosis.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Epclusa (sofosbuvir and velpatasvir) Prescribing Information. | 2022 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Hepatitis C guidance 2023 update: American Association for the Study of Liver Diseases– Infectious Diseases Society of America recommendations for testing, managing, and treating hepatitis C virus infection. | 2023 | Clinical Infectious Diseases |
EASL recommendations on treatment of hepatitis C: Final update of the series. | 2020 | Journal of Hepatology |