CROI 2018 Abstract eBook

Abstract eBook

Poster Abstracts

Conclusion: In this interim analysis of a real world cohort of HIV/HCV co- infected patients receiving ledipasvir/sofosbuvir, switches in ARVs were not associated with HIV treatment failure. While nephrotoxicity events did occur, these were not more common in controls and were not associated with TDF- containing regimens. HCV treatment success was independent of ARV switch and was achieved by all participants with complete follow-up to date.

Background: Current AASLD/IDSA guidelines recommend that black/African American (b/AA) genotype 1 hepatitis c virus (HCV) infected patients receive 12 weeks of ledipasvir/sofosbuvir (LDV/SOF) therapy, even if they otherwise meet criteria for 8 weeks. Recent studies have been conflicting regarding the efficacy in this group. This study aims to evaluate the efficacy of 8 weeks of LDV/SOF in a b/AA cohort. Methods: A retrospective, convenience sample study was conducted of b/ AA patients seen in a Washington, DC clinic from 11/2014 – 4/2017, who were eligible for 8 weeks of treatment. Patients who met criteria for 8 weeks of treatment but received 12 weeks were also evaluated. HCV RNA was collected at treatment week 4, end of treatment (EOT), and at sustained virologic response (SVR) (both 12 and 24 weeks). Data on adherence to medication and provider follow up, as well as acid-reducing (AR) medications, were collected. Results: Of patients in this clinical treatment cohort, 10% (n=59/596) met the criteria for this study: (1) Thirty five 8-week patients, mean age was 64 +6 years, 77% (n=27) were female, 54% (n=19) had a fibrosis score >F2, 74%were genotype 1a, and the median RNA value was 761,300 IU/ml (14,700 - 3,955,810); 21% (n=7) took AR medications, 9% (n=3) were non-adherent to HCV medication (9 – 35 missed doses), and 18% (n=19/105) of treatment appointments were missed. Of the twenty four 12-week patients, mean age was 64 +4 years, 67% (n=16) were male, 83% (n=20) had a fibrosis score >F2, 79%were genotype 1a, and the median RNA was 2,598,480 IU/ml (241,380 - 5,817,461); 20% (n=4) were on AR medications, 10% (n=2) were non-adherent to medication (9 missed), and 15% (n=11/72) of treatment appointments were missed. All patients in both groups achieved SVR. There were no statistically significant differences in these variables and between groups regarding age, genotype, medication and appointment adherence and AR medication use. However, in the 8-week group, there were more females (p<0.01), earlier liver fibrosis (p<0.02), and lower baseline RNA (p<0.01). Conclusion: The data show that b/AA patients in a real-world clinical setting achieved SVR when completing 8 weeks of HCV treatment. Larger studies should evaluate the utility of using 8 weeks of treatment in b/AA patients as shorter treatment duration would be less costly and allow for more patients to be treated. 607 HIV PREDICTS FAILURE OF LDV/SOF IN HCV G1 TREATMENT-NAÏVE NON- CIRRHOTIC PATIENTS Juan Berenguer 1 , José L. Calleja 2 , Marisa Montes 3 , Ángela Gil-Martín 4 , Ana Moreno 5 , Rafael Bañares 1 , Teresa Aldámiz-Echevarría 1 , Agustín Albillos 5 , María J. Téllez 6 , Antonio Olveira 3 , Lourdes Domínguez-Domínguez 7 , Javier García- Samaniego 3 , Inma Jarrin 8 , María J. Calvo 4 , Juan González-García 3 1 General University Hospital Gregorio Marañón, Madrid, Spain, 2 Puerta de Hierro Research Institute and University Hospital, Madrid, Spain, 3 La Paz University Hospital, Madrid, Spain, 4 Servicio Madrileño de Salud, Madrid, Spain, 5 Hospital Ramon y Cajal, Madrid, Spain, 6 Hospital Universitario Clínico San Carlos, Madrid, Spain, 7 Hospital Universitario 12 de Octubre, Madrid, Spain, 8 Institute de Salud Carlos III, Majadahonda, Spain Background: The efficacy of licensed DAA regimens is assumed to be the same for HCV-monoinfected patients (MoP) and HIV/HCV-coinfected patients (CoP). However, the high SVR rates of DAA regimens and the relatively small number of patients included in registration trials have made it difficult to identify predictors of treatment failure, including the presence of HIV. We compared treatment outcomes for LDV/SOF against HCV G1 in treatment-naïve MoP and CoP without cirrhosis. Methods: Created in November 2014, RUA-VHC is a prospective registry of individuals receiving DAAs for HCV in hospitals from the Madrid Regional Health Service. For this study, we selected previously untreated non-cirrhotic patients with HCV G1 (the most prevalent genotype) who had received LDV/SOF (the most commonly used DAA regimen) without ribavirin for 8 or 12 wk. We assessed SVR at 12 wk after completion of treatment. Results: Up to September 2017, 17,269 patients (3,549 CoP) were registered in RUA-VHC. A total of 1,407 patients (1,102 MoP/305 CoP) met inclusion criteria. Significant differences between MoP and CoP were observed at baseline for age, gender, and G1 subtype distribution (Table). Among CoP, 43%were CDC-C, 59% nadir CD4+< 200/mm 3 , median baseline CD4+ 612/mm 3 , 99% on ART, and 94% undetectable HIV-RNA. SVR rates for LDV/SOF at 8 wk did not differ significantly between MoP and CoP (96.6% vs 94.0%; P=.25) (Table). However, the SVR rate for LDV/SOF at 12 wk was significantly higher for MoP than CoP (97.2% vs 91.9%; P<.001) (Table). A multivariable logistic regression model

605 UNREPORTED ALCOHOL USE WAS COMMON BUT DID NOT IMPACT HCV CURE IN HIV-INFECTED PWID Risha Irvin , Geetanjali Chander, Kathleen Ward, Oluwaseun Falade-Nwulia, Juhi Moon, Catherine Sutcliffe, Sherilyn Brinkley, Taryn Haselhuhn, Stephanie Katz, Kayla Herne, Lilian Arteaga, David L. Thomas, Shruti H. Mehta, Mark Sulkowski Johns Hopkins University, Baltimore, MD, USA Background: With interferon, alcohol could impair immunological responses and reduce the effectiveness of hepatitis C virus (HCV) treatment. Therefore, alcohol cessation was often required. However, HCV guidelines from the AASLD/ IDSA now prioritize treatment for all persons including those with heavy alcohol use with direct-acting antivirals. We investigated the prevalence of heavy alcohol use and the impact on the HCV care continuum in HIV/HCV coinfected persons who inject drugs (PWID). Methods: In the CHAMPS study, 144 HIV/HCV coinfected PWID were randomized to contingent cash incentives and peer-mentors to evaluate the impact on HCV treatment uptake and cure as compared to usual clinical care. At baseline, alcohol use was ascertained using the 10-item AUDIT and Phosphatidylethanol (PEth), an alcohol biomarker. Log binomial regression was used to evaluate associations between alcohol use with treatment initiation and cure. Results: The median age was 55, 61%were male, 92%were Black, 91% reported a history of injection drug use, 97%were on antiretroviral therapy, all had HCV genotype 1 infection, and 12% had cirrhosis. By AUDIT, 38 (26%) reported hazardous drinking while 71 (49%) had a negative PEth, 17 (12%) had a PEth < 50 ng/ml, and 47 (33%) had a PEth ≥ 50 ng/ml which denotes heavy alcohol use. Of the 47 individuals with a PEth ≥ 50 ng/ml, 23 (49%) reported drinking never, monthly or less, or 2-4 times per month by AUDIT. LDV/SOF was initiated in 110 of 144 participants and, of those who initiated LDV/SOF, cure was achieved in 91%. Neither PEth ≥ 50 ng/ml (Relative Risk [RR] 1.12, 95% CI 0.60-2.09) nor hazardous drinking by AUDIT in women (RR 0.77, 95% CI 0.22-2.66) or men (RR 1.60, 95% CI 0.79-3.26) were significantly associated with failure to initiate HCV treatment. Similarly, neither PEth ≥ 50 ng/ml (RR 1.08, 95% CI 0.64-1.83) nor hazardous drinking in women (RR 0.54, 95% CI 0.17-1.74) or men (RR 1.59, 95% CI 0.89-2.83) were significantly associated with failure to achieve cure. Conclusion: Alcohol use was common and frequently not detected by self- report which is concerning as alcohol use can lead to increased fibrosis and may impact liver disease progression post HCV cure. It was encouraging that heavy alcohol use, even when measured objectively, was not associated with failure to initiate HCV treatment or to achieve cure. This validates guidelines which prioritize treatment for persons who use alcohol including those with alcohol use disorders. 606 HIGH EFFICACY OF 8 WEEKS OF LEDIPASVIR/SOFOSBUVIR IN AFRICAN AMERICANS WITH HCV Whitney Nichols, Alexander Geboy, Cathy Gurgol, Chinyere Ukaegbu, Nicole Brown, Dawn Fishbein MedStar Health Research Institute, Hyattsville, MD, USA

Poster Abstracts

CROI 2018 223