CROI 2016 Abstract eBook

Abstract Listing

Poster Abstracts

(27-39) vs. 19% (16-22), respectively ( p =0.001). The table shows the comparison of characteristics of patients with and without rejection in the whole series of HIV-infected and HIV-uninfected patients. HIV infection (HR 95% CI:1.85, 1.40-2.45; p =<0.001) and early calendar period of LT (2002-2007) (HR 95% CI:1.33, 1.02-1.72; p =0.035) were the only factors independently associated with acute rejection. Among HIV-infected LT recipients, patients with rejection had a lower MELD score and older donor age compared to patients without rejection. HIV-related factors, such as history of opportunistic infections, CD4 cell count, serum HIV detectable viremia at LT or raltegravir-based initial post-LT antiretroviral therapy, were not associated with acute rejection. The development of acute rejection did not impact on survival. No significant differences were observed in the mortality rate in patients with vs. without acute rejection: 43% vs. 41% in the cohort of HIV-infected patients, and 36% vs. 32% in the cohort of HIV-uninfected patients, respectively. Conclusions: HIV-infected LT recipients have a higher incidence of acute rejection, although the development of acute rejection did not influence the survival. HIV infection was an independently associated factor of acute rejection. In the cohort of HIV-infected LT recipients, HIV infection-related factors were not associated with acute rejection

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Retreatment of HCV/HIV-Coinfected Patients Who Failed 12Weeks of LDV/SOF Curtis L. Cooper 1 ; Susanna Naggie 2 ; Michael S. Saag 3 ; Jenny C.Yang 4 ; Luisa M. Stamm 4 ; Hadas Dvory-Sobol 4 ; Philip S. Pang 4 ; John G. McHutchison 4 ; Douglas Dieterich 5 ; Mark Sulkowski 6 1 Ottawa Hosp - Univ of Ottawa, Ottawa, ON, Canada; 2 Duke Univ Sch of Med, Durham, NC, USA; 3 Univ of Alabama at Birmingham, Birmingham, AL, USA; 4 Gilead Scis, Inc, Foster City, CA, USA; 5 Mount Sinai Hosp, New York, NY, USA; 6 Johns Hopkins Univ, Baltimore, MD, USA Background: Ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination is highly effective and safe for genotype 1 HCV-infected patients with HIV co-infection. Of the 335 HCV/ HIV coinfected patients enrolled in the ION-4 Phase 3 study, 3% relapsed (n=10) after 12 weeks of LDV/SOF treatment. These patients were eligible for a retreatment substudy that evaluated the efficacy and safety of LDV/SOF (90 mg/400 mg) plus weight-based RBV for 24 weeks. Methods: Eligible patients were enrolled within 60 days from the time of confirmed virologic failure. NS5A and NS5B resistance associated variants (RAVs) were evaluated by deep sequencing prior to retreatment and at the time of virologic failure post-retreatment. The primary endpoint was SVR12. Results: Nine of 10 patients were enrolled and completed treatment. All patients were black, IL28B non-CC, HIV suppressed on ARV regimens with a median baseline CD4 count of 785 cells/uL (Q1, Q3 = 404, 971). The mean age was 57 years (range 35-65) and most were male (n=7), without cirrhosis (n=7), and had genotype 1a infection (n=7). The mean baseline HCV RNA was 6.2 log10 IU/mL (range 4.4-7.1). HIV ARV regimens included tenofovir+emtricitabine (TDF+FTC) with either efavirenz (n=7) or raltegravir (n=2). Prior to retreatment, 2 patients had no NS5A RAVs and 7 patients had high-level NS5A RAVs detected (see Table). The SOF-specific NS5B RAV S282T was not detected in any patients; 1 patient had L159F. Overall SVR12 rate was 89% (8/9): 1 patient relapsed. There were no treatment-emergent SAEs. Fatigue (n=6), cough (n=4), anemia (n=2) and arthralgia (n=2) were the most common adverse events. No significant lab abnormalities were observed and creatinine clearance was stable on treatment. No patient had confirmed HIV virologic rebound (HIV-1 RNA≥400 copies/mL). Conclusions: Ledipasvir/sofosbuvir with ribavirin for 24 weeks was well tolerated and demonstrated that successful retreatment is possible in the majority of these genotype 1-infected, NS5A-experienced HCV/HIV co-infected patients.

Poster Abstracts

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CROI 2016