sofosbuvir and velpatasvir
Regulatory sources consulted
Approved indications
- Treatment of chronic HCV infection in adults and pediatric patients weighing at least 30 kg who can receive the 400 mg/100 mg tablet.
Clinical warnings
- Assess HBV before starting because of severe reactivation risk. — DailyMed, set_id 996466df-f236-4804-b10f-838aa83231a1
- Combination with amiodarone may cause severe bradycardia or heart block. — DailyMed, set_id 996466df-f236-4804-b10f-838aa83231a1
Drug interactions
- HighP-gp/CYP inducers such as rifampicin, carbamazepine, or St John’s wort
Mechanism: They reduce both antivirals and may cause failure.
Recommendation: The combination is not recommended.
DailyMed, set_id 996466df-f236-4804-b10f-838aa83231a1
- HighProton-pump inhibitors and other acid reducers
Mechanism: They reduce velpatasvir absorption.
Recommendation: Separate antacids by 4 hours. H2 antagonists may be given simultaneously or 12 hours apart within dose limits. PPIs are not recommended; if essential, take Epclusa with food and omeprazole 20 mg 4 hours afterward.
DailyMed, set_id 996466df-f236-4804-b10f-838aa83231a1
- ModerateVitamin K antagonists and antidiabetic agents
Mechanism: HCV clearance may change INR or glucose control.
Recommendation: Closely monitor INR or glucose and adjust if needed.
DailyMed, set_id 996466df-f236-4804-b10f-838aa83231a1
Adverse events
Common (≥1%)
Headache and fatigue
Rare but serious
HBV reactivation and severe bradycardia
Pregnancy and lactation
Human data are insufficient to characterize the risk of sofosbuvir/velpatasvir in pregnancy or its presence in human milk. If the regimen includes ribavirin, apply its strict pregnancy and contraception contraindications.
Recent literature (PubMed)
We report a case of bilateral neuroretinitis like picture following ingestion of Direct Acting Antivirals (DAAs) in the form of sofosbuvir and velpatasvir, for treatment of Chronic Hepatitis C infection. retrospective observational case report and review of literature. A healthy 49 years old male, known case of Chronic heptatis C; developed bilateral painless diminution of vision following treatment with DAAs-sofosbuvir and velpatasvir-for treatment-naïve hepatitis C. After thorough work up, ruling out other causes and stopping of medications there was complete resolution of the lesions. Ocular side effects of Direct Acting Antivirals (DAAs) for treatment of Chronic Hepatitis C should be considered, as these are now standard care of treatment for the same.
Chronic hepatitis C (HCV) affects up to 3.25 million children and adolescents. Early treatment of HCV in children and adolescents reduces progression to advanced liver disease and cancer. Treatment for HCV has evolved to highly effective direct acting antiviral therapy in adults and now in children ≥3 years of age. This review focuses on the role of sofosbuvir and velpatasvir (SOF/VEL), a newer treatment of children and adolescents with chronic HCV. SOF/VEL is a pangenotypic DAA with primary clearance via the liver and biliary excretion. It has been studied in children and adolescents and is approved in the US for use in children and adolescents ≥3 years of age. Although the data are currently limited, SOF/VEL has demonstrated sustained viral response rates similar to comparable DAAs in the range of 95-98%. To date, side effects have been minimal.
Hepatitis C virus (HCV) is a global public health concern with significant impacts. It primarily spreads through blood-to-blood contact, such as sharing needles among drug users. Given the wide prevalence of risk factors, HCV continues to pose a major threat. Hence, it is crucial to understand its characteristics, structure, and genotypes to prevent, treat, and potentially eradicate it. This narrative review aims to explore the history of HCV treatment, highlight the breakthroughs achieved with direct-acting antiviral (DAA) therapy, address potential barriers to HCV eradication, and discuss future treatment possibilities. For this article, relevant studies were identified using various databases, including PubMed, ClinicalTrials.gov, and Journal Storage. The literature search revealed that after identifying HCV and studying its characteristics, interferon alfa and ribavirin became primary treatment options. However, due to their limited coverage against different HCV genotypes, ethnic variations, and suboptimal sustained virological response, the development of DAAs became essential. Combining various DAAs, such as sofosbuvir and velpatasvir, for a duration of 12 weeks has become the standard HCV treatment, with effectiveness against most genotypes. Additionally, ongoing clinical trials have shown promising results for other drugs such as CDI31244/sofosbuvir/velpatasvir, sofosbuvir/coblopasvir, and daclatasvir/asunaprevir. Despite the success of DAAs and ongoing efforts to discover more effective treatments, the high costs of DAAs pose a significant challenge to eradicating HCV, as not all patients can afford these expensive therapies. Furthermore, the ability of HCV to mutate limits the potential for vaccine development. Therefore, it is crucial to focus on developing more cost-effective strategies to control the spread of HCV and create novel, highly effective, and affordable DAAs.
The real-world virological efficacy and safety of interferon-free direct-acting antiviral (DAA) therapy with sofosbuvir (SOF) and velpatasvir (VEL) were assessed in hepatitis C virus (HCV) genotype 1- and 2-infected patients with decompensated cirrhosis. A total of 65 patients with HCV-related decompensated cirrhosis (Child-Pugh score of 7 points or more) who were treated with the SOF/VEL regimen were enrolled. The sustained virological response (SVR) rate and safety profile were analyzed. SVR was defined as undetectable serum HCV RNA at 12 weeks after the end of treatment (SVR12). The percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 81.2% (95% confidence interval [CI], 69.5-89.9) (52/64), 98.4% (95% CI, 91.2-100.0) (60/61), and 98.5% (95% CI, 91.7-100.0) (64/65), respectively. The overall SVR rate was 92.3% (95% CI, 83.0-97.5) (60/65). Albumin-bilirubin (ALBI) scores decreased during and after treatment (p < 0.001), and there were significant differences between baseline and end of treatment and between baseline and SVR12. Subgroup analyses showed no significant differences in SVR rates according to patient age, sex, HCV genotype (subtype), Child-Pugh classification, modified ALBI grade, presence of ascites, presence of hepatic coma, or history of hepatocellular carcinoma. In all subpopulations, the SVR rates were higher than 80%. There were no severe adverse events associated with the treatment. The SOF/VEL regimen showed good virological efficacy and acceptable safety even in patients with HCV-related decompensated cirrhosis.