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N Engl J Med. 2015 Aug 20;373(8):705-13. doi: 10.1056/NEJMoa1501315. Epub 2015 Jul 21.

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

Author information

  • 1From Duke Clinical Research Institute, Durham, NC (S.N.); University of Ottawa, the Ottawa Hospital, Ottawa (C.C.), and Department of Hepatology, Immunodeficiency Clinic, Toronto General Hospital, University of Toronto, Toronto (D.K.W.) - both in Canada; University of Alabama at Birmingham, Birmingham (M. Saag); Emory University, Emory Healthcare, Atlanta (K.W.); Ruane Medical and Liver Health Institute (P.R.) and Kaiser Permanente Los Angeles Medical Center (W.J.T.), Los Angeles, University of California, San Francisco, San Francisco General Hospital, San Francisco (A.L.), and Gilead Sciences, Foster City (L.M.S., J.C.Y., P.G., H.D.-S., L.N., P.S.P., J.G.M.) - all in California; Weill Cornell Medical College (K.M.), Icahn School of Medicine at Mount Sinai (N.B., D.D.), New York, and James J. Peters Veterans Affairs Medical Center, Bronx (N.B.) - all in New York; Beth Israel Deaconess Medical Center (R.P.B.), Brigham and Women's Hospital and Harvard Medical School (P.E.S.), and Community Research Initiative of New England (A.E.C.) - all in Boston; University of Auckland, Auckland City Hospital, Auckland (E.G.), and Christchurch Hospital and University of Otago, Christchurch (C.A.M.S.) - both in New Zealand; University of Puerto Rico School of Medicine (J.S.-B.) and Clinical Research Puerto Rico (J.O.M.-R.) - both in San Juan; University of Miami, Miami (D.J.); University of Pennsylvania, Philadelphia (P.T.); and Johns Hopkins University School of Medicine, Baltimore (M. Sulkowski).

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.).

PMID:
26196665
[PubMed - indexed for MEDLINE]
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