Drug updated on 4/24/2024
| 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.
Summary
- Sofosbuvir (Sovaldi) is indicated for the treatment of adult and pediatric patients with chronic HCV infection. It shows high efficacy across various populations, including adults, adolescents, and children as young as 3 years. The drug maintains competitive SVR12 rates and a favorable safety profile compared to other pan-genotypic regimens like glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL).
- The information was derived from 22 systematic reviews/meta-analyses, providing extensive data on Sovaldi's safety, efficacy, and considerations for specific subgroups.
- For patients with severe renal impairment or end-stage renal disease (ESRD), studies suggest that combinations like sofosbuvir/ledipasvir offer safe treatment options with high SVR rates, although patient response varies significantly, necessitating careful selection.
- Treating experienced populations who have had prior exposure to DAAs, sofosbuvir/velpatasvir/voxilaprevir has proven highly efficacious while maintaining a good safety profile.
- Patients suffering from decompensated cirrhosis can be effectively treated using SOF-based regimens, which showcase significant SVR rates. Among these treatments, sofosbuvir combined with velpatasvir±ribavirin achieved higher sustained virological responses, making it suitable for this fragile group.
- Data indicates lower sustained virological response in hepatocellular carcinoma patients when treated by SOF-based therapies compared to non-HCC patients, emphasizing the need for early effective interventions in such cases.
- A potential risk identified during the use of sofosbuvir-based treatments, particularly SOF/VEL/VOX, is grade 3 hyperglycemia, indicating that special attention should be paid to managing diabetes during HCV treatment among diabetic patients.
- Sofosbuvir's adaptability across all HCV genotypes, particularly in combination with other agents, ensures its role as a cornerstone therapy for HCV. However, the incidence of adverse events points to the need for cautious monitoring and possibly dose adjustments in certain patient subsets.
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 |