Drug updated on 12/11/2024
| 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 | Hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitors and HCV NS5A inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated 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
- Indicated 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
- This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
- Virological Failure and Resistance-Associated Substitutions (RAS): Sofosbuvir/velpatasvir exhibited virological failure rates comparable to other direct-acting antiviral (DAA) regimens, with a high prevalence of RAS at 78%. Similar RAS rates were observed in other regimens, including sofosbuvir/daclatasvir (81%) and glecaprevir/pibrentasvir (79%), while retreatment with sofosbuvir/velpatasvir/voxilaprevir showed an even higher RAS prevalence of 93%.
- Sustained Virological Response (SVR12) Across Populations: In genotype 2 (GT2) patients, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir achieved a 100% SVR12 rate. Among pediatric and adolescent patients, sofosbuvir/velpatasvir achieved SVR12 rates of 95% in adolescents, 93% in older children, and 83% in young children. For end-stage renal disease (ESRD) patients, the SVR12 rate with sofosbuvir/velpatasvir was 97.69%, and for decompensated cirrhotic patients, it reached 91%, outperforming other sofosbuvir-based regimens such as sofosbuvir/ledipasvir (86.3%) and sofosbuvir/daclatasvir (82.4%).
- Kidney Transplant Recipients and Other Genotypes: Kidney transplant recipients treated with sofosbuvir/velpatasvir achieved complete viral eradication at 12 weeks post-treatment. Additionally, genotype 3 patients treated with sofosbuvir/velpatasvir achieved an SVR12 rate of 95.08%, underscoring the regimen's efficacy across different genotypes.
- Common and Serious Adverse Events (AEs): Fatigue (14%) and headache (13.1%) were the most common adverse events associated with sofosbuvir/velpatasvir. Serious adverse events (SAEs) and deaths were uncommon overall, though grade 3 hyperglycemia occurred in 2.1% of diabetic patients treated with sofosbuvir/velpatasvir/voxilaprevir.
- Pediatric and Special Populations: Younger children experienced higher rates of adverse events (72%) compared to adolescents (50%) and older children (53%). Among end-stage renal disease (ESRD) patients, no serious adverse events were reported with sofosbuvir/velpatasvir. In decompensated cirrhotic patients, adding ribavirin to sofosbuvir-based regimens led to a notable increase in adverse event frequency.
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 |
|---|---|---|
| Updated Clinical Guidelines on the Management of Hepatitis C Infection in Children | 2024 | Pathogens |
| ESPGHAN recommendations on treatment of chronic hepatitis C virus infection in adolescents and children including those living in resource-limited settings | 2024 | Journal of Pediatric Gastroenterology and Nutrition |
| Hepatitis C Guidance 2023 Update: AASLD-IDSA 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 |
| Japan Society of Hepatology guidelines for the management of hepatitis C virus infection: 2019 update | 2020 | Hepatology Research |