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

Open access
Naggie, Susanna, Cooper, Curtis, Saag, Michael, Workowski, Kimberly, Ruane, Peter, Towner, William J., Marks, Kristen, Luetkemeyer, Anne, Baden, Rachel P., Sax, Paul E., Gane, Edward, Santana-Bagur, Jorge, Stamm, Luisa M., Yang, Jenny C., German, Polina, Dvory-Sobol, Hadas, Ni, Liyun, Pang, Phillip S., McHutchison, John G., Stedman, Catherine A.M., Morales-Ramirez, Javier O., Bräu, Norbert, Jayaweera, Dushyantha, Colson, Amy E., Tebas, Pablo, Wong, David K., Dieterich, Douglas, Sulkowski, Mark·2015·New England Journal of Medicine

Abstract

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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Authors
Naggie, S., Cooper, C., Saag, M., Workowski, K., Ruane, P., Towner, W. J., Marks, K., Luetkemeyer, A., Baden, R. P., Sax, P. E., Gane, E., Santana-Bagur, J., Stamm, L. M., Yang, J. C., German, P., Dvory-Sobol, H., Ni, L., Pang, P. S., McHutchison, J. G., Stedman, C. A. M., Morales-Ramirez, J. O., Bräu, N., Jayaweera, D., Colson, A. E., Tebas, P., Wong, D. K., Dieterich, D., & Sulkowski, M.
Venue
New England Journal of Medicine
Published
2015-08-20
Volume
373
Issue
8
Pages
705-713
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2332403844
Cited by
470
References
20
FWCI
51.51
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. https://app.cochat.ai/papers/10.1056/nejmoa1501315
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Naggie, S., Cooper, C., Saag, M., Workowski, K., Ruane, P., Towner, W. J., Marks, K., Luetkemeyer, A., Baden, R. P., Sax, P. E., Gane, E., Santana-Bagur, J., Stamm, L. M., Yang, J. C., German, P., Dvory-Sobol, H., Ni, L., Pang, P. S., McHutchison, J. G., . . . Sulkowski, M. (2015). Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1501315

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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