CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

sufficiently clarified. Some studies point to a higher mortality in the setting of HIV/HCV-coinfection, while others find no difference. Methods: Multicenter cohort study (GEHEP-011 Cohort-clinicaltrials. gov ID: NCT04460157-) including individuals with HIV/HCV coinfection or HCV-monoinfection from 18 Spanish hospitals. They met: 1) Liver stiffness measurement (LMS) ≥9.5 kPa before treatment; 2) SVR with a DAA-based regimen; 3) LSM at SVR. The main outcome was overall survival. Mortality attributable to liver disease and non-hepatic causes was also assessed. The propensity score (PS) for HIV was calculated. The association between the main variable and the various parameters analyzed was assessed by the log-rank test in the bivariate analysis and by multivariate Cox regression, including PS as a covariate. Results: 1,119 patients (HIV/HCV: 677; HCV: 442) were included. The median follow-up from the time of SVR of individuals with HIV/HCV-coinfection and HCV-monoinfection 78 and 73 months, respectively. There was no significant difference in the proportion of pre-treatment individuals with cirrhosis (HIV/ HCV: 62%, HCV: 57%, p=0.135) nor in LSM, Child category or MELD score at the time of SVR. Among people with HIV, 98% had an HIV viral load<200 c/mL at SVR and the median (Q1-Q3) CD4+ cell count was 573 (352-786) cells/mm 3 . After SVR, 46 (10%) HCV-monoinfected and 74 (11%) HIV/HCV-coinfected patients died. Thirty-three patients died of liver disease, 1 of AIDS and 86 of other causes. The overall survival rate at 5 and 7 years was, respectively: HCV: 89% and 86%; HIV/HCV: 90% and 87% (p=0.707). There was no difference in hepatic and non hepatic mortality between the two subpopulations. In multivariable analysis adjusted for age, sex, HIV infection and PS, independent predictors of all-cause death were age, MELD index and LSM at the time of SVR, but not HIV infection (HR [95% CI]: 1.01[0.67-1.53]; p=0.970]. Conclusion: In patients with HCV infection, HIV coinfection does not reduce overall survival or mortality attributable to hepatic and non-hepatic causes after SVR. Differences in the control of HIV infection or in other survival-limiting factors could explain the disparity in the data found in the different cohorts. Direct-Acting Antivirals and Risk of Hepatocellular Carcinoma in People With HIV/HCV Coinfection Daniela K van Santen , for the HepCAUSAL Collaboration Harvard TH Chan School of Public Health, Boston, MA, USA Background: Hepatitis C virus (HCV) infection is a leading cause of hepatocellular carcinoma (HCC). While direct-acting antivirals (DAA) cure ~95% of individuals with HCV, precise estimates of HCC risk and of risk trends post-DAA are urgently needed to inform HCC surveillance. We aimed to estimate the effect of DAA treatment on HCC risk in people with HIV/HCV co-infection and advanced liver fibrosis or cirrhosis. Methods: We emulated a target trial using data on individuals with HIV/HCV from HepCAUSAL, a collaboration of 12 cohorts from Europe and North America. The eligibility criteria were: HIV infection, chronic HCV infection, advanced liver fibrosis or cirrhosis (clinical cirrhosis diagnosis, liver stiffness ≥9.5 kPa, or FIB-4 ≥3.25), DAA naïve, HIV-RNA <200 copies/mL, on antiretroviral therapy, no hepatitis B virus co-infection, and no previous HCC diagnosis or liver transplant. The treatment strategies were DAA initiation versus no DAA use during the follow-up. The outcome was incident HCC. We emulated a sequence of trials starting each month between Jan 2013 and Dec 2022 and individuals could be eligible in and contribute follow-up to multiple trials. We censored individuals in the no DAA group if/when they initiated DAA. We estimated the 4-year cumulative incidence of HCC under the two DAA strategies with adjustment for confounding and loss to follow-up via inverse probability weighting. Results: Of 3,871 eligible individuals (87% males, median age of 56 [IQR: 50,61]), 71% initiated DAAs and 108 had an incident HCC diagnosis. These individuals contributed on average to 19 trials. The estimated 4-year HCC risk was 1.37% (95% CI: 0.90, 1.94) in the DAA group and 3.07% (95% CI: 1.84, 4.38) in the no DAA group, corresponding to a risk difference of -1.69% (95% CI: -3.16, -0.20) and a risk ratio of 0.45 (95% CI: 0.24, 0.89). In the DAA group, the risk of HCC was approximately constant over time (Figure) with a mean annual incidence of 0.35% (95% CI: 0.17, 0.59). Conclusion: We estimated that DAA reduces the 4-year HCC risk by 2% on an absolute scale and 55% on a relative scale in people with HIV/HCV co-infection and advanced fibrosis or cirrhosis. The annual HCC risk after DAA initiation was close to the threshold (0.4%) beyond which HCC surveillance is deemed cost effective, which suggests that continued post-cure HCC monitoring is warranted in this population.

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Simultaneous Start Strategy With BIC/FTC/TAF in Individuals With HIV/ HCV Coinfection in China Qing Lin 1 , Feng Wang 1 , Li Li 1 , Hongmei Zhu 1 , Yuan Yao 2 , Jingchun He 2 , Zheng Li 1 , Zhenglin Wang 1 , Qingmei Zhou 1 , Zuwei Xia 1 , Yiping Yang 1 , Zehu Deng 1 1 Jiulongpo District People's Hospital, Chongqing, China, 2 Jiulongpo District Public Health Medical Center, Chongqing, China Background: Highly Active Antiretroviral treatment (ART) with Direct-acting antiviral agents (DAAs) has demonstrated high efficacy and favorable safety profile in HIV/HCV co-infected individuals with HIV viral suppression and stable immune status. However there is great need in rapid initiation of ART and anti-HCV treatment regardless of HIV viral suppression status and CD4 T cell count as a simplified treatment strategy-To "Simultaneous Start" treatment for both HIV and HCV. Methods: We conducted a retrospective, single-center study in Southwest China from May 2021 to August 2023. The study aimed to evaluate effectiveness and safety of immediate initiation or switch to bictegravir/emtricitabine/ tenofovir alafenamide (BIC/FTC/TAF) with sofosbuvir/velpatasvir (SOF/VEL) administered once daily respectively in PWH(people with HIV) with recent acquired HCV. The primary endpoints were HIV and HCV viral suppression rate, defined as HIV RNA <20 cp/mL at 12 weeks and HCV RNA <15 IU/mL at 24 weeks after the end of HCV-treatment (SVR24). Results: Of the 128 patients enrolled, mean age of 36 years (31-39, IQR), 77% male (n=99). 52 were ART naive (TN), 76 were ART experienced (TE). The baseline characteristics were summarized in Table 1. All patients achieved HIV RNA suppression at 12 weeks and 36 weeks, 98.4% (126/128) patients achieved HCV SVR24. Among individuals with baseline CD4 T cell count < 200 cells/mm³ (n=32, 25%) , all achieved SVR 24. And 98% (94/96) of those with baseline CD4 cell count > 200 cells/mm³ (n=96, 75%) achieved SVR 24. The two patients who did not achieve SVR24 were PWID(people who inject drugs) infected with HCV genotype 3, had cirrhosis and poor adherence. Nine HBV/HCV/HIV co-infected patients maintained or achieved HBV DNA undetectable at 12 weeks and 36 weeks of treatment. No patient discontinued treatment due to adverse events. Conclusion: \Immediate initiation or switch to BIC/FTC/TAF with SOF/VEL treatment provided high HIV and HCV suppression rate with a favorable safety profile. The study suggests that HCV treatment can start immediately without waiting for the CD4 T cell count to exceed 200 cells/mm³ in HIV/HCV co-infected individuals. This simplified "Simultaneous Start" treatment may be a feasible and easy treatment strategy for HIV/HCV co-infected individuals. The figure, table, or graphic for this abstract has been removed. Similar Mortality Among Individuals With HIV/HCV-Coinfection and HCV-Monoinfection After SVR Anais Corma-Gomez 1 , Jessica Martin-Carmona 2 , Francisco Tellez 3 , Miriam Serrano-Fuentes 4 , Luis E. Morano 5 , Diana Corona-Mata 6 , Maria Jose Rios 7 , Francisco J. Vera-Mendez 8 , Isabel Barroso 9 , Rosario Palacios 10 , Ignacio de los Santos 11 , Paloma Geijo 12 , Juan Antonio Pineda 1 , Juan Macias 1 , for the GEHEP-011 Study Group 1 Hospital Universitario de Valme, Seville, Spain, 2 Hospital de Puerto Real, Puerto Real, Spain, 3 Hospital Universitario de Puerto Real, Cadiz, Spain, 4 Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria, 5 Hospital Universitario Alvaro Cunqueiro, Vigo, Spain, 6 Hospital Universitario Reina Sofia, Cordoba, Spain, 7 Hospital Universitario Virgen Macarena, Sevilla, Spain, 8 Hospital General Universitario Santa Lucía, Cartagena, Spain, 9 Hospital Universitario Jerez de la Frontera, Jerez de la Frontera, Spain, 10 Hospital Virgen de la Victoria, Málaga, Spain, 11 Hospital Universitario de La Princesa, Madrid, Spain, 12 Hospital Virgen de la Luz, Cuenca, Spain Background: The life expectancy of the patient with controlled HIV infection is similar to that of individuals without HIV infection. In patients with chronic HCV infection, the impact of HIV coinfection on their clinical course after SVR is not

Poster Abstracts

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