Related Experiment Videos
Real-World Experiences With a Direct-Acting Antiviral Agent for Patients With Hepatitis C Virus Infection
Vincent Louie1, Nyan L Latt2, Derenik Gharibian3
1Ambulatory Care Pharmacist at the Los Angeles Medical Center in CA. vincent.x.louie@kp.org.
Context:
Traditional hepatitis C virus treatment was limited by low cure rates, side effects, and stringent monitoring requirements. Sofosbuvir, a direct-acting antiviral agent with a cure rate of 96%, was introduced in 2013. However, trials frequently excluded patients with advanced liver disease and prior treatment experience. This study aims to elucidate the real-world cure rates and sofosbuvir safety profile.
Methods:
A retrospective cohort study was conducted at Kaiser Permanente Southern California involving patients with hepatitis C virus who received sofosbuvir treatment. Patients age 18 years and older were included, and pregnant patients were excluded. The primary end point was sustained virologic response at 12 weeks posttreatment. Secondary end points were safety and medication adherence. Multiple logistic regression analysis was used to compare patients with genotypes 1 and 2 infections.
Results:
Of the 213 study patients, 42.3% had cirrhosis, and 38% were treatment-experienced. Most patients (69.5%) received dual therapy (sofosbuvir + ribavirin), whereas the remainder (30.5%) received triple therapy (sofosbuvir + ribavirin + interferon). The overall rate of sustained virologic response at 12 weeks posttreatment rate was 72.9% for genotype 1 infection, 64.7% in the treatment-experienced subgroup, and 66.7% in the cirrhosis subgroup. Rates of sustained virologic response at 12 weeks posttreatment for genotypes 2 and 3 were 90.8% and 55%, respectively. Most patients experienced anemia and fatigue. Women and patients with a lower baseline viral load were statistically more likely to be cured.
Conclusion:
Real-world cure rates were similar to rates seen in clinical trials for genotype 2 infection and lower for genotype 1 infection. Patients with genotype 1 and 3 infection did better with triple therapy compared with dual therapy. Patients tolerated therapy well with side effects, serious adverse events, and discontinuation rates similar to clinical trials. Women and patients with lower baseline hepatitis C viral load were more likely to achieve sustained virological response at 12 weeks posttreatment.
Insights
Real-world hepatitis C virus treatment with sofosbuvir showed lower cure rates for genotype 1 infections than clinical trials. However, patients tolerated the therapy well, with similar side effect profiles to previous studies.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Traditional hepatitis C virus (HCV) treatments had limitations including low cure rates and significant side effects.
- Sofosbuvir, a direct-acting antiviral, offered improved efficacy but clinical trials often excluded patients with advanced liver disease or prior treatment experience.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of sofosbuvir-based treatment for hepatitis C virus.
- To compare cure rates in patients with different HCV genotypes, treatment experience, and liver disease severity.
Main Methods:
- A retrospective cohort study at Kaiser Permanente Southern California included 213 adult patients with HCV receiving sofosbuvir.
- Primary endpoint was sustained virologic response (SVR) at 12 weeks posttreatment; secondary endpoints included safety and adherence.
- Logistic regression analyzed differences between genotypes 1 and 2 infections.
Main Results:
- Overall SVR at 12 weeks was 72.9% for genotype 1, 90.8% for genotype 2, and 55% for genotype 3.
- Patients with cirrhosis (42.3%) and treatment-experienced patients (38%) had lower SVR rates.
- Triple therapy (sofosbuvir + ribavirin + interferon) showed better outcomes than dual therapy for genotypes 1 and 3.
Conclusions:
- Real-world SVR rates for sofosbuvir were comparable to clinical trials for genotype 2 but lower for genotype 1.
- Triple therapy improved outcomes for genotype 1 and 3 infections.
- Sofosbuvir therapy was generally well-tolerated, with adverse events and discontinuation rates similar to clinical trials.