Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 200 mg, 400 mg); Pellets (oral; 150 mg, 200 mg) |
| Drug Class | HCV nucleotide analog NS5B polymerase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen.
- Indicated for the treatment of pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.
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Summary
- Sovaldi (sofosbuvir) is indicated for the treatment of adult patients with genotype 1, 2, 3, or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen, and for the treatment of pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.
- This summary is based on the review of 22 systematic review(s)/meta-analysis(es). [1-22]
- GLE/PIB regimen achieved SVR12 rates of 100% in adolescents, 96% in older children, and 96% in young children. SOF/VEL regimen showed SVR12 rates of 95% in adolescents, 93% in older children, and 83% in young children. SOF/DCV regimen had an SVR12 rate of 100% in both adolescents and older children.
- SOF/VEL regimen demonstrated an overall SVR12 rate of 97.69%, with a rate of 91.94% in cirrhotic patients, and comparable efficacy between genotype 3 and non-genotype 3 infections. GLE/PIB regimen showed a pooled SVR rate of 99.4%, being a highly effective pan-genotypic option.
- SOF/VEL±Ribavirin regimen achieved an SVR12 of 91%, compared to 86.3% with SOF/LDV±Ribavirin and 82.4% with SOF/DCV±Ribavirin.
- SOF-based regimens had a pooled SVR12 rate of 97% in advanced CKD patients, with different SOF dosing strategies showing high efficacy: 92% for 400 mg alternate days, 98% for 400 mg daily, and 100% for 200 mg daily.
- Adverse events (AEs) were reported in 50% of adolescents, 53% of older children, and 72% of young children treated with sofosbuvir-based regimens, with serious adverse events (SAEs) and treatment discontinuations being uncommon (<1% in adolescents and older children, 3% in young children).
- In patients with decompensated cirrhosis, the addition of Ribavirin to SOF-based regimens significantly increased the frequency of AEs from 52.9% to 89.2%, as well as the incidence of severe events.
- Among chronic kidney disease (CKD) and hemodialysis patients, the most common AEs included fatigue (16%), anemia (15%), and nausea/vomiting (14%), with anemia being more prevalent in Ribavirin-containing regimens (46%) compared to Ribavirin-free regimens (3%).
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sovaldi (sofosbuvir) Prescribing Information. | 2020 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease: Synopsis of the Kidney Disease: Improving Global Outcomes 2022 Clinical Practice Guideline. | 2022 | Annals of Internal Medicine |
| HCV Guidance: recommendations for testing, managing, and treating Hepatitis C. | 2021 | American Association for the Study of Liver 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 |
| APASL clinical practice recommendation: how to treat HCV-infected patients with renal impairment? | 2019 | Hepatology International |