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Sofosbuvir and Simeprevir Combination Therapy for HCV Genotype 1 Infection: Results of a Single-Center VA Experience
Seth N Sclair1, Maria Del Pilar Hernandez1, Evan Vance1
1Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
Insights
All-oral antiviral therapy, including sofosbuvir and simeprevir, effectively treated chronic hepatitis C virus (HCV) infection in US veterans. This regimen demonstrated high cure rates and feasibility, supporting its continued use in veteran healthcare.
Area of Science:
- Hepatology
- Infectious Diseases
- Pharmacotherapy
Background:
- Chronic hepatitis C virus (HCV) infection poses a significant health burden among US veterans.
- The Veterans Affairs (VA) healthcare system prioritizes HCV treatment due to high prevalence and associated liver disease.
- All-oral antiviral regimens represent a significant advancement in HCV treatment accessibility and efficacy.
Purpose of the Study:
- To evaluate the feasibility and effectiveness of an all-oral antiviral combination (sofosbuvir and simeprevir) for treating HCV genotype 1 infection in US veterans.
- To compare the sustained virologic response (SVR) rates of different treatment regimens.
- To assess treatment tolerability and compliance in this patient population.
Main Methods:
- A single-center study involving 100 US veterans with HCV genotype 1 infection treated between December 2013 and June 2014.
- Patients received either sofosbuvir and simeprevir (with or without ribavirin) for 12 weeks, or sofosbuvir-based regimens including pegylated interferon and ribavirin.
- Data on treatment completion, tolerability, and SVR rates were collected and analyzed.
Main Results:
- The all-oral sofosbuvir and simeprevir regimen achieved a high SVR rate of 88.4%.
- This rate was significantly superior to the 50.0% SVR achieved with sofosbuvir, pegylated interferon, and ribavirin.
- Treatment was well-tolerated with over 95% compliance for all-oral therapy; cirrhotic patients showed lower SVR rates.
Conclusions:
- The combination of sofosbuvir and simeprevir is a feasible and highly effective all-oral treatment for chronic HCV genotype 1 infection in veterans.
- The regimen achieves a near 90% cure rate, underscoring the importance of incorporating novel HCV medications into the VA formulary.
- Continued expansion of HCV treatment access for US veterans using advanced antiviral therapies is recommended.
Abstract:
Treatment of chronic hepatitis C virus (HCV) infection remains a priority in the veterans affairs (VA) health care system nationwide, as there is a high burden of liver disease due to HCV infection among US veterans. The combination of sofosbuvir and simeprevir was the first all-oral antiviral regimen used in clinical practice to treat veterans with HCV infection. In this study, we report a single-center experience showing both the feasibility and effectiveness of this all-oral combination to treat HCV genotype 1 infection. One hundred patients with HCV genotype 1 infection were treated between December 2013 and June 2014. Eighty-six patients were treated with sofosbuvir and simeprevir, with or without ribavirin, for 12 weeks; 12 patients were treated with sofosbuvir, pegylated interferon, and ribavirin for 12 weeks; and 2 patients were treated with sofosbuvir and ribavirin for 24 weeks. Overall, treatment was well tolerated and feasible, with compliance rates over 95% in patients treated with all-oral therapy. The sustained virologic response (SVR) rate for sofosbuvir and simeprevir (88.4%) was superior to the rate for sofosbuvir, pegylated interferon, and ribavirin (50.0%). Subgroup analysis showed diminished SVR rates in cirrhotic patients vs noncirrhotic patients. There were no significant differences in SVR when comparing treatment with or without ribavirin or among genotype subtypes. In conclusion, this study demonstrated excellent completion rates for all-oral treatment of veterans with chronic HCV infection. Additionally, treatment was highly effective, nearing a 90% cure rate. Thus, we recommend that the VA health care system continue to incorporate new HCV medications into its formulary so as to expand HCV treatment for US veterans.
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