TY - JOUR
T1 - Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities
AU - Ho, Samuel B.
AU - Monto, Alexander
AU - Peyton, Adam
AU - Kaplan, David E.
AU - Byrne, Sean
AU - Moon, Scott
AU - Copans, Amanda
AU - Rossaro, Lorenzo
AU - Roy, Anupma
AU - Le, Hadley
AU - Dvory-Sobol, Hadas
AU - Zhu, Yanni
AU - Brainard, Diana M.
AU - Guyer, William
AU - Shaikh, Obaid
AU - Fuchs, Michael
AU - Morgan, Timothy R.
AU - Brown, Geri
AU - Cheung, Ramsey
AU - Fuchs, Michael
AU - Gilliam, Bruce
AU - Ho, Sam
AU - Jeffers, Lennox
AU - Kaplan, David
AU - Lim, Joseph
AU - Monto, Alexander
AU - Morgan, Timothy
AU - Naggie, Susanna
AU - Pandya, Prashant
AU - Peyton, Adam
AU - Rimland, David
AU - Shaikh, Obaid
AU - Talwani, Rohit
AU - Yoffee, Boris
AU - Cartwright, Emily
N1 - Publisher Copyright:
© 2017 AGA Institute
PY - 2017/2/1
Y1 - 2017/2/1
N2 - Background & Aims We conducted a phase 4, open-label study with limited exclusion criteria to evaluate the safety and efficacy of sofosbuvir and ribavirin in veterans with hepatitis C virus genotype 2 infection, and compensated cirrhosis. This population is often excluded from clinical studies. Methods We performed a prospective study of treatment-naive (n = 47) and treatment-experienced (n = 19) patients with chronic hepatitis C virus genotype 2 infection and compensated cirrhosis at 15 Department of Veterans Affairs sites. All subjects were given sofosbuvir (400 mg, once daily) plus ribavirin (1000–1200 mg/day) in divided doses for 12 weeks. Patients with major psychiatric diseases or alcohol or substance use disorders were not excluded. The primary endpoint was sustained virologic response 12 weeks after therapy. Results Fifty-two patients achieved a sustained virologic response 12 weeks after therapy (79%; 95% confidence interval, 67%–88%); 16 of these patients were treatment experienced (84%; 95% confidence interval, 60%–97%) and 36 were treatment naive (77%; 95% confidence interval, 62%–88%). All patients had at least 1 comorbidity. Thirty-five percent had depression, 24% had posttraumatic stress disorder, and 30% had anxiety disorder. In addition, 29% had current substance use. Of the 7 patients (11%) who discontinued the study treatment prematurely, 3 did so because of adverse events. The most common adverse events were fatigue, anemia, nausea, and headache. Serious adverse events occurred in 8 patients. Only 2 of the serious adverse events (anemia and nausea) were considered to be related to study treatment. Conclusions In a phase 4 study, 12 weeks treatment with sofosbuvir and ribavirin led to a sustained virologic response 12 weeks after therapy in almost 80% of veterans with hepatitis C virus genotype 2 infection, compensated cirrhosis, and multiple comorbidities, regardless of their treatment history. ClinicalTrials.gov,
AB - Background & Aims We conducted a phase 4, open-label study with limited exclusion criteria to evaluate the safety and efficacy of sofosbuvir and ribavirin in veterans with hepatitis C virus genotype 2 infection, and compensated cirrhosis. This population is often excluded from clinical studies. Methods We performed a prospective study of treatment-naive (n = 47) and treatment-experienced (n = 19) patients with chronic hepatitis C virus genotype 2 infection and compensated cirrhosis at 15 Department of Veterans Affairs sites. All subjects were given sofosbuvir (400 mg, once daily) plus ribavirin (1000–1200 mg/day) in divided doses for 12 weeks. Patients with major psychiatric diseases or alcohol or substance use disorders were not excluded. The primary endpoint was sustained virologic response 12 weeks after therapy. Results Fifty-two patients achieved a sustained virologic response 12 weeks after therapy (79%; 95% confidence interval, 67%–88%); 16 of these patients were treatment experienced (84%; 95% confidence interval, 60%–97%) and 36 were treatment naive (77%; 95% confidence interval, 62%–88%). All patients had at least 1 comorbidity. Thirty-five percent had depression, 24% had posttraumatic stress disorder, and 30% had anxiety disorder. In addition, 29% had current substance use. Of the 7 patients (11%) who discontinued the study treatment prematurely, 3 did so because of adverse events. The most common adverse events were fatigue, anemia, nausea, and headache. Serious adverse events occurred in 8 patients. Only 2 of the serious adverse events (anemia and nausea) were considered to be related to study treatment. Conclusions In a phase 4 study, 12 weeks treatment with sofosbuvir and ribavirin led to a sustained virologic response 12 weeks after therapy in almost 80% of veterans with hepatitis C virus genotype 2 infection, compensated cirrhosis, and multiple comorbidities, regardless of their treatment history. ClinicalTrials.gov,
KW - Clinical Trial
KW - DAA
KW - NS5B Inhibitor
KW - Substance Abuse
KW - VA
UR - http://www.scopus.com/inward/record.url?scp=84990313627&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84990313627&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2016.05.024
DO - 10.1016/j.cgh.2016.05.024
M3 - Article
C2 - 27237429
AN - SCOPUS:84990313627
SN - 1542-3565
VL - 15
SP - 282
EP - 288
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 2
ER -