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Sofosbuvir/velpatasvir: A promising combination
Aldo Bonaventura1, Fabrizio Montecucco1
1Aldo Bonaventura, Fabrizio Montecucco, First Clinic of Internal Medicine, Department of Internal Medicine, University of Genoa School of Medicine, IRCCS Azienda Ospedaliera Universitaria San Martino-IST Istituto Nazionale per la Ricerca sul Cancro, 16132 Genoa, Italy.
Insights
New direct antiviral agents (DAAs) offer highly effective Hepatitis C virus (HCV) treatment. Oral regimens combining sofosbuvir and velpatasvir show over 90% sustained virological response in HCV genotypes 2 and 3.
Area of Science:
- Hepatology
- Virology
- Infectious Diseases
Background:
- Hepatitis C virus (HCV) affects 3% globally, causing chronic liver disease and extra-hepatic complications like type 2 diabetes.
- HCV has 7 genotypes with varying characteristics influencing disease progression and treatment response.
- Recent advancements include direct antiviral agents (DAAs) targeting viral replication proteins.
Purpose of the Study:
- To evaluate the efficacy and safety of novel oral DAAs for Hepatitis C virus infection.
- To assess treatment outcomes for specific HCV genotypes using combined antiviral therapies.
Main Methods:
- Phase 3 clinical trials (ASTRAL-2 and ASTRAL-3) were conducted.
- The study involved patients aged 18+ with at least 6 months of HCV infection and compensated liver disease.
- Sofosbuvir (NS5B polymerase inhibitor) and velpatasvir (NS5A inhibitor) were administered as oral regimens.
Main Results:
- Regimens combining DAAs achieved sustained virological response rates exceeding 90%.
- Treatment duration was reduced to 12 weeks or less.
- Sofosbuvir and velpatasvir demonstrated effectiveness, safety, and good tolerability in patients with HCV genotypes 2 and 3.
Conclusions:
- Oral DAAs, including sofosbuvir and velpatasvir, represent a significant advancement in HCV treatment.
- These regimens offer a highly effective and well-tolerated option for patients with compensated liver disease across different HCV genotypes.
Abstract:
Hepatitis C virus (HCV) affects 3% of the world population. It represents the main cause of chronic liver disease and is responsible for extra-hepatic complications, such as type 2 diabetes and cardiovascular diseases. HCV includes 7 genotypes differing in the nucleotide sequence variability, the geographic distribution, the rates of viral clearance, the risk of progression to liver fibrosis and to hepatocellular carcinoma, and the response to therapy. Last years have seen remarkable advances in the field of HCV infection with the approval of direct antiviral agents (DAAs) targeting key viral proteins involved in the HCV replication. Several oral regimens combining DAAs from different families have been developed and these regimens showed increased and sustained virological response rates to above 90% reducing the treatment duration to 12 wk or less. In particular, sofosbuvir, a nucleotide analogue nonstructural (NS)5B polymerase inhibitor, and velpatasvir, a NS5A inhibitor, have been tested in two phase 3 trials, the ASTRAL-2 (against HCV genotype 2) and the ASTRAL-3 (against HCV genotype 3), demonstrating to be effective, safe, and well tolerated in patients who were 18 years of age or older and had at least a 6-mo history of HCV infection with a compensated liver disease.
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