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

Publication ,  Journal Article
Ho, SB; Monto, A; Peyton, A; Kaplan, DE; Byrne, S; Moon, S; Copans, A; Rossaro, L; Roy, A; Le, H; Dvory-Sobol, H; Zhu, Y; Brainard, DM ...
Published in: Clin Gastroenterol Hepatol
February 2017

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.

Duke Scholars

Published In

Clin Gastroenterol Hepatol

DOI

EISSN

1542-7714

Publication Date

February 2017

Volume

15

Issue

2

Start / End Page

282 / 288

Location

United States

Related Subject Headings

  • Veterans
  • Treatment Outcome
  • Sustained Virologic Response
  • Sofosbuvir
  • Ribavirin
  • Prospective Studies
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ho, S. B., Monto, A., Peyton, A., Kaplan, D. E., Byrne, S., Moon, S., … VALOR study team, . (2017). Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. Clin Gastroenterol Hepatol, 15(2), 282–288. https://doi.org/10.1016/j.cgh.2016.05.024
Ho, Samuel B., Alexander Monto, Adam Peyton, David E. Kaplan, Sean Byrne, Scott Moon, Amanda Copans, et al. “Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities.Clin Gastroenterol Hepatol 15, no. 2 (February 2017): 282–88. https://doi.org/10.1016/j.cgh.2016.05.024.
Ho SB, Monto A, Peyton A, Kaplan DE, Byrne S, Moon S, et al. Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. Clin Gastroenterol Hepatol. 2017 Feb;15(2):282–8.
Ho, Samuel B., et al. “Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities.Clin Gastroenterol Hepatol, vol. 15, no. 2, Feb. 2017, pp. 282–88. Pubmed, doi:10.1016/j.cgh.2016.05.024.
Ho SB, Monto A, Peyton A, Kaplan DE, Byrne S, Moon S, Copans A, Rossaro L, Roy A, Le H, Dvory-Sobol H, Zhu Y, Brainard DM, Guyer W, Shaikh O, Fuchs M, Morgan TR, VALOR study team. Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. Clin Gastroenterol Hepatol. 2017 Feb;15(2):282–288.
Journal cover image

Published In

Clin Gastroenterol Hepatol

DOI

EISSN

1542-7714

Publication Date

February 2017

Volume

15

Issue

2

Start / End Page

282 / 288

Location

United States

Related Subject Headings

  • Veterans
  • Treatment Outcome
  • Sustained Virologic Response
  • Sofosbuvir
  • Ribavirin
  • Prospective Studies
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Humans