Drug updated on 4/26/2024
| 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.
Summary
- Sofosbuvir and velpatasvir (Epclusa) is 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. It can also be used in combination with ribavirin for treating those same patients who have decompensated cirrhosis.
- The information about this drug was derived from a total of eight systematic reviews/meta-analyses documents that provided comprehensive understanding of its efficacy and safety compared to other treatments for Hepatitis C Virus (HCV) infection across diverse populations.
- In terms of population type considerations, Epclusa showed high effectiveness in adolescents with SVR12 rates of around 83% to 95%, slightly lower than glecaprevir/pibrentasvir (GLE/PIB), and sofosbuvir/daclatasvir (SOF/DCV). However, it had good tolerability as adverse events increased only marginally among younger ages.
- For subgroup considerations such as Decompensated Cirrhosis Patients, SOF/VEL achieved higher sustained virologic response (SVR) rates (91%) compared to SOF/Ledipasvir and SOF/Daclatasvir variants. This indicates superior efficacy within this subgroup while maintaining a safety profile when not combined with Ribavarin, which tends to increase adverse effects.
- Compared to other drugs used in treating chronic HCV infections like GLE/PIB & SOF/DAC, Epclusa consistently shows high SVR12 rates across various genotypes, including traditionally hard-to-treat ones like Genotype 3 (GT3).
- Sofosbuvir/Velpatasvir has been shown to be effective even amongst patient demographics considered challenging, such as those suffering from End Stage Renal Disease (ESRD) and children, making it a versatile option for treating HCV across diverse patient subgroups.
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 |