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

Research output: Contribution to journalArticle

14 Citations (Scopus)

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)
JournalClinical Gastroenterology and Hepatology
DOIs
StateAccepted/In press - 2016
Externally publishedYes

Fingerprint

Ribavirin
Veterans
Hepacivirus
Comorbidity
Fibrosis
Genotype
Infection
Therapeutics
Confidence Intervals
Nausea
Anemia
Sofosbuvir
Chronic Hepatitis C
Post-Traumatic Stress Disorders
Anxiety Disorders
Substance-Related Disorders
Fatigue
Headache
Psychiatry
History

Keywords

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

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. / Ho, Samuel B.; Monto, Alexander; Peyton, Adam; Kaplan, David E.; Byrne, Sean; Moon, Scott; Copans, Amanda; Rossaro, Lorenzo; Roy, Anupma; Le, Hadley; Dvory-Sobol, Hadas; Zhu, Yanni; Brainard, Diana M.; Guyer, William; Shaikh, Obaid; Fuchs, Michael; Morgan, Timothy R.

In: Clinical Gastroenterology and Hepatology, 2016.

Research output: Contribution to journalArticle

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 2016, 'Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities', Clinical Gastroenterology and Hepatology. https://doi.org/10.1016/j.cgh.2016.05.024
Ho, Samuel B. ; Monto, Alexander ; Peyton, Adam ; Kaplan, David E. ; Byrne, Sean ; Moon, Scott ; Copans, Amanda ; Rossaro, Lorenzo ; Roy, Anupma ; Le, Hadley ; Dvory-Sobol, Hadas ; Zhu, Yanni ; Brainard, Diana M. ; Guyer, William ; Shaikh, Obaid ; Fuchs, Michael ; Morgan, Timothy R. / Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. In: Clinical Gastroenterology and Hepatology. 2016.
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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 . .",
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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.

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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, Number: . NCT02128542 . .

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, Number: . NCT02128542 . .

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