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Treatment of the most difficult-to-cure hepatitis C virus-infected population with sofosbuvir / velpatasvir
Robert Flisiak1, Dorota Zarębska-Michaluk2, Hanna Berak3
1Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Białystok, Poland. robert.flisiak1@gmail.com
Insights
Pangenotypic hepatitis C virus (HCV) therapy is effective, but some patients, particularly men with cirrhosis, obesity, and genotype 3 infection, experience lower cure rates. Further research is needed to optimize treatment for these difficult-to-cure populations.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Pangenotypic therapies offer a universal approach to treating hepatitis C virus (HCV) infections.
- Despite high effectiveness, certain patient groups exhibit a risk of treatment failure with these regimens.
Purpose of the Study:
- To identify patient populations most challenging to cure using the sofosbuvir/velpatasvir (SOF/VEL) regimen.
- To evaluate the effectiveness of SOF/VEL±ribavirin (RBV) in less responsive and complex patient cohorts.
Main Methods:
- Retrospective analysis of 2267 HCV-infected patients treated with SOF/VEL±RBV in the EpiTer-2 multicenter study.
- Evaluation of sustained virologic response rates across various patient subgroups, including genotype 3, cirrhosis, male sex, and obesity (BMI > 30).
Main Results:
- An overall sustained virologic response rate of 96.4% was observed in the study population.
- Lower cure rates were noted in specific subgroups: 79.1% in men with cirrhosis and obesity infected with GT3, and 66.7% in those with prior treatment failure.
Conclusions:
- The SOF/VEL regimen shows reduced effectiveness in treatment-experienced men with cirrhosis, obesity, and GT3 infection.
- Consideration of triple therapy (e.g., adding RBV) may be warranted for this high-risk group.
- Factors such as sex, BMI, and treatment history significantly impact pangenotypic therapy effectiveness, necessitating further investigation.
Introduction:
Pangenotypic therapies for infections with hepatitis C virus (HCV), although universal and highly effective, entail a risk of treatment failure.
Objectives:
Our study aimed to identify the population of HCV‑infected patients most difficult to cure with the sofosbuvir / velpatasvir (SOF/VEL) regimen.
Patients And Methods:
The effectiveness of the SOF/VEL regimen with a possible addition of ribavirin (RBV) was evaluated in populations known to be less responsive to treatment, and then in a population characterized by the combination of all factors impairing effectiveness, comprising patients treated with this regimen in the EpiTer‑2 multicenter retrospective study.
Results:
A total of 2267 patients were treated with SOF/VEL±RBV. Of those, 2078 (96.4%) achieved sustained virologic response. The cure rate was 93.5% among 646 patients infected with genotype (GT) 3, 92.3% among 635 patients with cirrhosis, 95.5% in a population of 1233 men, and 94.1% among 421 patients with body mass index (BMI) above 30. An analysis in a group of 43 men with cirrhosis and obesity infected with GT3 showed the effectiveness of pangenotypic therapy at only 79.1%, falling to 66.7% in individuals with previous treatment failure.
Conclusions:
In a large population of SOF/VEL‑treated HCV‑infected patients, we showed relatively low effectiveness of the regimen in treatment‑experienced men with cirrhosis and obesity, infected with GT3. Triple therapy should be considered when initiating the treatment of HCV infections in this group, which, however, needs to be confirmed in further studies. Previous studies were conducted in less demanding populations, because they did not take into account sex and BMI, which significantly affect the treatment effectiveness.
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