CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

may lead to higher cure rates and may allow for a shorter treatment duration. Here we present an interim analysis of the first 27 patients treated in the DAHH-Study, evaluating the efficacy and tolerability of a 12-week boceprevir, P+R regimen in AHCV genotype 1 infections in 10 participating Dutch hospitals. Methods: HIV+ patients visiting the outpatient clinic with a new ALAT rise above the upper limit of normal were screened for the presence of HCV RNA. If positive, stored historical plasma samples (within 6 months) were tested to prove that the HCV infection was recent. Boceprevir, P+R for 12 weeks was started without a P+R lead-in and was initiated no later than 26 weeks after the presumed day of infection. Primary endpoint is sustained viral response at week 24(SVR24) in patients with no HCV RNA detected (Roche, CAP/CTM) at w4(RVR4) and in all patients included(secondary endpoint). Results: Since September 2013 we screened 104 HIV+ patients with a new HCV infection. We excluded 42 patients because of genotype 4 (n=17), HCV infection >6 months (n=11), spontaneous clearance (n=6) and refusal to participate (n=8). Twelve patients are currently awaiting clearance. Fifty were included of which 37 have started therapy at abstract submission. RVR4 was reached in 23/33 (70%) patients with end of treatment (EOT) responses being 26/29 (90%). SVR12 was 18/19 (95%, 95% CI 72%-99%) in the RVR4 population. SVR12 was 21/27 (78%, 95% CI 57%-91%) in patients regardless of RVR4 results. Updated SVR12 data of the first 35 patients will be presented at the congress. Conclusions: Addition of boceprevir to P+R for AHCV treatment results in SVR12 rates of 95% (95% CI 72%-99%) with a 50% shorter therapy duration as long as HCV RNA has become negative at w4. Regardless of RVR4 the SVR12 is comparable with 24 weeks P+R (78%, 95% CI 57%-91%). The DAHHS network allows for a fast and accurate evaluation of new DAA for the treatment of AHCV in a significant number of patients. 670 Does the Availability of New DAAs Influence Treatment Uptake in Acute Hepatitis C in HIV Coinfection? Christoph Boesecke 1 ; Mark Nelson 2 ; Patrick Ingiliz 5 ;Thomas Lutz 3 ; Stefan H. Scholten 4 ; Christoph D. Spinner 6 ; Michael Rausch 9 ;Thomas Reiberger 7 ; Stefan Mauss 8 ; Jürgen Rockstroh 1 1 Bonn University Hospital, Bonn, Germany; 2 Chelsea and Westminster Hospital, NHS Foundation Trust, London, United Kingdom; 3 Infektiologikum, Frankfurt/Main, Germany; 4 Praxis Hohenstaufenring, Cologne, Germany; 5 MiB, Berlin, Germany; 6 Interdisciplinary HIV Centre (IZAR), University Hospital Klinikum Rechts der Isar, Munich, Germany; 7 Medical University of Vienna, Vienna, Austria; 8 Center for HIV and Hepatogastroenterology, Duesseldorf, Germany; 9 Aerztezentrum Nollendorfplatz, Berlin, Germany Background: With the availability of newer DAAs for treatment of chronic hepatitis C infection (HCV) HCV therapy has become considerably less toxic and even more successful than treatment of acute hepatitis C infection (AHC) with pegylated interferon (pegIFN) and ribavirin (RBV). Current DAA-based regimens are not approved for treatment of AHC and thus, also not reimbursed. Here we evaluate potential changes in the annual rates of treatment initiation in Europe for AHC coinfection in the DAA era. Methods: The PROBE-C study is an observational European cohort on AHC in HIV coinfection. Between 2007-2014 483 AHC episodes were documented in 461 HIV-infected patients from Austria, Denmark, France, Germany, Great Britain and Spain. Fisher’s exact, chi-square and Mann-Whitney U test were used for statistical analysis. Results: All patients were male, median age was 41 years. Main routes of transmission were MSM (97.4%) and IVDU (2.6%). 77.4% of patients were infected with HCV GT1 and 18.9%with GT4. Median baseline HCV-RNA was 2.019.500IU/mL and median CD4+ T cell count 478 cells/ m L. 93% of all patients received cART, 86% had baseline suppressed HIV-RNA (<200copies/mL). Median ALT was 388 U/l. In 60/483 (12.6%) episodes AHC resolved spontaneously, in 309/483 (64%) treatment with pegIFN/RBV was initiated within 24 weeks of AHC diagnosis. Median time from diagnosis to treatment initiation was 8 weeks. SVR rate was 70%. Overall, as shown in table 1 there was an increase in treatment initiation for AHC from 2007-2012. However, since 2012 an annual decline from 76% to 45%was observed. There was no association between treatment initiation and HCV transmission risk, HCV GT, HCV RNA levels nor baseline ALT.

Poster Abstracts

Table 1. Annual rates of treatment initiation for new AHC diagnoses from 2007 to 2014 Conclusions: Treatment uptake for AHC has substantially decreased in the last 2 years potentially reflecting patients’ and/or physicians’ wish for a short, well-tolerated and highly successful DAA-based therapy which to date is only approved and reimbursed for treatment of chronic HCV infection. However, when treatment during AHC is withhold, more patients remain viremic, which then may foster the epidemic of AHC among HIV-infected MSM. Therefore, studies evaluating safety and efficacy of IFN-free DAA regimens for AHC are urgently needed. 671 Long-Term Follow-Up of HIV-Positive MenWho Have Sex With Men (MSM) With Acute Hepatitis C Virus (HCV) Infection: High Rates of Treatment and Low Rates of Liver-Related Complications Patrick Ingiliz 1 ; Anders C. Boyd 3 ; Katharina Steininger 1 ; Andreas Carganico 1 ; Stephan Dupke 1 ; Ivanka Krznaric 1 ; Marcel Schuetze 1 ; Stefan Neifer 2 ; Martin J. Obermeier 1 ; Axel Baumgarten 1 1 Medical Center for Infectious Diseases, Berlin, Germany; 2 Microbiology Laboratory, Berlin, Germany; 3 INSERM UMR_S 1136, Paris, France Background: Acute hepatitis C has been identified as a major factor of morbidity in HIV-infected MSM. Interferon-based treatments have been extensively used in this population in Europe. However, benefits related to treatment remain unknown in this population, bringing into question the use of interferon in the era of directly acting antivirals. Methods: Retrospective analysis of HIV-positive MSM with acute HCV infection from a single center in Berlin from 2002 to 2013. Liver fibrosis was estimated by transient elastography (Fibroscan®) and/or serummarkers (Fibrotest®). The following endpoints were documented: significant fibrosis, cirrhosis, HCC, liver-related death, liver transplant, non-liver-related death. Risk-factors for significant fibrosis and liver cirrhosis were determined using a proportional hazards regression model with death as a competing risk. Results: 207 cases of acute hepatitis C occurred in 174 MSM. The median age was 39 years (IQR: 32-45), the median CD4 count was 514 mm 3 (IQR: 386-675), the maximum ALT level was 416 U/L (IQR: 157-868). Most patients were genotype 1a (79%), and genotype 4 (11%). A total of 22/207 (10.6%) acute infections cleared spontaneously, which was

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CROI 2015