Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities

Samuel B. Ho, Alexander Monto, Adam Peyton, David E. Kaplan, Sean Byrne, Scott Moon, Amanda Copans, Lorenzo Rossaro, Anupma Roy, Hadley Le, Hadas Dvory-Sobol, Yanni Zhu, Diana M. Brainard, William Guyer, Obaid Shaikh, Michael Fuchs, Timothy R. Morgan, Geri Brown, Ramsey Cheung, Michael FuchsBruce Gilliam, Sam Ho, Lennox Jeffers, David Kaplan, Joseph Lim, Alexander Monto, Timothy Morgan, Susanna Naggie, Prashant Pandya, Adam Peyton, David Rimland, Obaid Shaikh, Rohit Talwani, Boris Yoffee, Emily Cartwright

Research output: Contribution to journalArticle

14 Scopus citations

Abstract

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, Number: NCT02128542

Original languageEnglish (US)
Pages (from-to)282-288
Number of pages7
JournalClinical Gastroenterology and Hepatology
Volume15
Issue number2
DOIs
StatePublished - Feb 1 2017

Keywords

  • Clinical Trial
  • DAA
  • NS5B Inhibitor
  • Substance Abuse
  • VA

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Ho, S. B., Monto, A., Peyton, A., Kaplan, D. E., Byrne, S., Moon, S., Copans, A., Rossaro, L., Roy, A., Le, H., Dvory-Sobol, H., Zhu, Y., Brainard, D. M., Guyer, W., Shaikh, O., Fuchs, M., Morgan, T. R., Brown, G., Cheung, R., ... Cartwright, E. (2017). Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. Clinical Gastroenterology and Hepatology, 15(2), 282-288. https://doi.org/10.1016/j.cgh.2016.05.024