Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Publication/Presentation Date
8-20-2015
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.).
Volume
373
Issue
8
First Page
705
Last Page
713
ISSN
1533-4406
Published In/Presented At
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., … ION-4 Investigators (2015). Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. The New England journal of medicine, 373(8), 705–713. https://doi.org/10.1056/NEJMoa1501315
Disciplines
Medicine and Health Sciences
PubMedID
26196665
Department(s)
Department of Medicine
Document Type
Article