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Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection.

Publication ,  Journal Article
Sulkowski, MS; Naggie, S; Lalezari, J; Fessel, WJ; Mounzer, K; Shuhart, M; Luetkemeyer, AF; Asmuth, D; Gaggar, A; Ni, L; Svarovskaia, E ...
Published in: JAMA
July 23, 2014

IMPORTANCE: Treatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon. OBJECTIVE: To determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment. DESIGN, SETTING, AND PARTICIPANTS: Open-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants. INTERVENTIONS: Treatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks. MAIN OUTCOMES AND MEASURES: The primary study outcome was the proportion of patients with SVR (serum HCV <25 copies/mL) 12 weeks (SVR12) after cessation of HCV therapy. RESULTS: Among treatment-naive participants, 87 patients (76%) of 114 (95% CI, 67%-84%) with genotype 1, 23 patients (88%) of 26 with genotype 2 (95% CI, 70%-985), and 28 patients (67%) of 42 with genotype 3 (95% CI, 51%-80%) achieved SVR12. Among treatment-experienced participants, 22 patients (92%) of 24 with genotype 2 (95% CI, 73%-99%) and 16 patients (94%) of 17 (95% CI, 71%-100%) achieved SVR12. The most common adverse events were fatigue, insomnia, headache, and nausea. Seven patients (3%) discontinued HCV treatment due to adverse events. No adverse effect on HIV disease or its treatment was observed. CONCLUSIONS AND RELEVANCE: In this open-label, nonrandomized, uncontrolled study, patients with HIV who were coinfected with HCV genotype 1, 2, or 3 who received the oral, interferon-free combination of sofosbuvir and ribavirin for 12 or 24 weeks had high rates of SVR12. Further studies of this oral regimen in diverse populations of coinfected patients are warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01667731.

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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

July 23, 2014

Volume

312

Issue

4

Start / End Page

353 / 361

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Uridine Monophosphate
  • Treatment Outcome
  • Sofosbuvir
  • Ribavirin
  • RNA, Viral
  • Middle Aged
  • Male
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
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Sulkowski, M. S., Naggie, S., Lalezari, J., Fessel, W. J., Mounzer, K., Shuhart, M., … PHOTON-1 Investigators, . (2014). Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA, 312(4), 353–361. https://doi.org/10.1001/jama.2014.7734
Sulkowski, Mark S., Susanna Naggie, Jacob Lalezari, Walford Jeffrey Fessel, Karam Mounzer, Margaret Shuhart, Anne F. Luetkemeyer, et al. “Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection.JAMA 312, no. 4 (July 23, 2014): 353–61. https://doi.org/10.1001/jama.2014.7734.
Sulkowski MS, Naggie S, Lalezari J, Fessel WJ, Mounzer K, Shuhart M, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014 Jul 23;312(4):353–61.
Sulkowski, Mark S., et al. “Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection.JAMA, vol. 312, no. 4, July 2014, pp. 353–61. Pubmed, doi:10.1001/jama.2014.7734.
Sulkowski MS, Naggie S, Lalezari J, Fessel WJ, Mounzer K, Shuhart M, Luetkemeyer AF, Asmuth D, Gaggar A, Ni L, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Rodriguez-Torres M, Dieterich D, PHOTON-1 Investigators. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014 Jul 23;312(4):353–361.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

July 23, 2014

Volume

312

Issue

4

Start / End Page

353 / 361

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Uridine Monophosphate
  • Treatment Outcome
  • Sofosbuvir
  • Ribavirin
  • RNA, Viral
  • Middle Aged
  • Male
  • Humans