Drug updated on 11/1/2024
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.
Latest News
Summary
- This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
- Sofosbuvir/Velpatasvir (SOF/VEL) achieved high sustained virologic response at 12 weeks (SVR12) rates, exceeding 90% across various populations, including a 100% SVR12 in hepatitis C virus (HCV) genotype 2 (GT2) patients. In contrast, Sofosbuvir/Daclatasvir (SOF/DCV) demonstrated near 100% SVR12 rates in adolescents and GT3 patients.
- Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) showed effectiveness as a salvage treatment in DAA-experienced patients, with pooled SVR12 rates between 93-96%, although effectiveness was lower in patients with genotype 3, cirrhosis, or prior SOF/VEL failure.
- Glecaprevir/Pibrentasvir (GLE/PIB) consistently achieved SVR12 rates close to 100% across different populations, including pediatric and adolescent groups, and was notably effective for HCV GT2 patients.
- Effectiveness varied significantly by population, with Pomalidomide-based regimens showing better outcomes in earlier treatment lines (2L population having an ORR of 87.2% and a CR rate of 29.7%), while non-cirrhotic patients generally experienced higher SVR rates compared to cirrhotic patients.
- Common Adverse Events (AEs) for Sofosbuvir-based regimens included fatigue (14%) and headache (13.1%), while serious adverse events (SAEs) were rare, with pooled rates below 1% for most regimens, although slightly higher in patients with cirrhosis or genotype 3 receiving Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX).
- Discontinuation rates due to adverse events were low (<1%), indicating a generally favorable safety profile across the studied regimens, including in pediatric populations where younger children experienced slightly higher AE rates.
- Diabetic patients receiving SOF/VEL/VOX exhibited rare instances of grade 3 hyperglycemia, particularly among those with cirrhosis or genotype 3, underscoring the need for careful monitoring in this subgroup.
- Age Groups: Sofosbuvir-based regimens, including SOF/VEL, SOF/DCV, and GLE/PIB, demonstrated high effectiveness with SVR12 rates often close to 100% in adolescents and children, although younger children exhibited slightly higher rates of adverse events.
- Genotypes: In HCV genotype 2 (GT2) patients, SOF/VEL and GLE/PIB achieved 100% SVR12 rates, while SOF/VEL/VOX was less effective in genotype 3 (GT3) compared to other genotypes; GLE/PIB showed higher effectiveness in GT3 patients.
- Cirrhosis: Non-cirrhotic patients had higher SVR rates than cirrhotic patients, who experienced lower SVR rates and increased adverse events, including instances of hyperglycemia.
- Renal Impairment and Prior Treatment Experience: SOF-based regimens were effective and safe in patients with stage 4-5 chronic kidney disease (CKD) with recommended monitoring, and SOF/VEL/VOX was effective in DAA-experienced patients, though slightly lower efficacy was noted in those with prior SOF/VEL failure or GT3.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Sovaldi (sofosbuvir) Prescribing Information. | 2020 | Gilead Sciences, Inc., Foster City, CA |