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Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1.

Publication ,  Journal Article
Naggie, S; Cooper, C; Saag, M; Workowski, K; Ruane, P; Towner, WJ; Marks, K; Luetkemeyer, A; Baden, RP; Sax, PE; Gane, E; Santana-Bagur, J ...
Published in: N Engl J Med
August 20, 2015

BACKGROUND: Effective treatment for hepatitis C virus (HCV) in patients coinfected with human immunodeficiency virus type 1 (HIV-1) remains an unmet medical need. METHODS: We conducted a multicenter, single-group, open-label study involving patients coinfected with HIV-1 and genotype 1 or 4 HCV receiving an antiretroviral regimen of tenofovir and emtricitabine with efavirenz, rilpivirine, or raltegravir. All patients received ledipasvir, an NS5A inhibitor, and sofosbuvir, a nucleotide polymerase inhibitor, as a single fixed-dose combination for 12 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Of the 335 patients enrolled, 34% were black, 55% had been previously treated for HCV, and 20% had cirrhosis. Overall, 322 patients (96%) had a sustained virologic response at 12 weeks after the end of therapy (95% confidence interval [CI], 93 to 98), including rates of 96% (95% CI, 93 to 98) in patients with HCV genotype 1a, 96% (95% CI, 89 to 99) in those with HCV genotype 1b, and 100% (95% CI, 63 to 100) in those with HCV genotype 4. Rates of sustained virologic response were similar regardless of previous treatment or the presence of cirrhosis. Of the 13 patients who did not have a sustained virologic response, 10 had a relapse after the end of treatment. No patient had confirmed HIV-1 virologic rebound. The most common adverse events were headache (25%), fatigue (21%), and diarrhea (11%). No patient discontinued treatment because of adverse events. CONCLUSIONS: Ledipasvir and sofosbuvir for 12 weeks provided high rates of sustained virologic response in patients coinfected with HIV-1 and HCV genotype 1 or 4. (Funded by Gilead Sciences; ION-4 ClinicalTrials.gov number, NCT02073656.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 20, 2015

Volume

373

Issue

8

Start / End Page

705 / 713

Location

United States

Related Subject Headings

  • Viral Load
  • Uridine Monophosphate
  • Sofosbuvir
  • RNA, Viral
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic
  • Hepacivirus
  • HIV-1
 

Citation

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Chicago
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MLA
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Naggie, S., Cooper, C., Saag, M., Workowski, K., Ruane, P., Towner, W. J., … ION-4 Investigators. (2015). Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med, 373(8), 705–713. https://doi.org/10.1056/NEJMoa1501315
Naggie, Susanna, Curtis Cooper, Michael Saag, Kimberly Workowski, Peter Ruane, William J. Towner, Kristen Marks, et al. “Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1.N Engl J Med 373, no. 8 (August 20, 2015): 705–13. https://doi.org/10.1056/NEJMoa1501315.
Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, et al. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):705–13.
Naggie, Susanna, et al. “Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1.N Engl J Med, vol. 373, no. 8, Aug. 2015, pp. 705–13. Pubmed, doi:10.1056/NEJMoa1501315.
Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, Marks K, Luetkemeyer A, Baden RP, Sax PE, Gane E, Santana-Bagur J, Stamm LM, Yang JC, German P, Dvory-Sobol H, Ni L, Pang PS, McHutchison JG, Stedman CAM, Morales-Ramirez JO, Bräu N, Jayaweera D, Colson AE, Tebas P, Wong DK, Dieterich D, Sulkowski M, ION-4 Investigators. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):705–713.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 20, 2015

Volume

373

Issue

8

Start / End Page

705 / 713

Location

United States

Related Subject Headings

  • Viral Load
  • Uridine Monophosphate
  • Sofosbuvir
  • RNA, Viral
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic
  • Hepacivirus
  • HIV-1