CROI 2018 Abstract eBook

Abstract eBook

Oral Abstracts

Conclusion: An 8 week course of grazoprevir/elbasvir (a NS3/NS5a combination) is highly effective for the treatment of acute HCV. The results of all 63 patients will be presented.

(16.7%). One patient had a serious AE of cholelithiasis considered unrelated to the treatment by the investigator. There were no study discontinuations. No significant laboratory abnormalities were observed. Conclusion: Preliminary data show that the combination of direct-acting antiviral agents G/P + SOF + RBV yielded a high rate of SVR4 in patients who had VF with G/P treatment. The retreatment regimen was well tolerated. Study enrollment is ongoing and updated results, including the SVR12 rate for this subset of patients, will be reported at the conference.

Oral Abstracts

128 8 WEEKS OF GRAZOPREVIR/ELBASVIR FOR ACUTE HCV: A MULTICENTER CLINICAL TRIAL (DAHHS 2) Anne Boerekamps 1 , Anja De Weggheleire 2 , Guido van den Berk 3 , Fanny Lauw 4 , Mark Claassen 5 , Dirk Posthouwer 6 , Wouter Bierman 7 , Sebastiaan Hullegie 1 , Eric Florence 2 , Anton Dofferhoff 8 , Joop E. Arends 9 , Bart Rijnders 1 1 Erasmus University Medical Center, Rotterdam, Netherlands, 2 Institute of Tropical Medicine, Antwerp, Belgium, 3 OLVG, Amsterdam, Netherlands, 4 Slotervaart MC, Amsterdam, Netherlands, 5 Rijnstate Hospital, Arnhem, Netherlands, 6 Maastricht University Medical Center+, Maastricht, Netherlands, 7 University Medical Center Groningen, Groningen, Netherlands, 8 Radboud University Medical Center, Nijmegen, Netherlands, 9 University Medical Center Utrecht, Utrecht, Netherlands Background: The arrival of direct acting antiviral (DAA) therapy for chronic hepatitis C (HCV) infection has led to speculations about HCV elimination. Modeling and real-life data on HCV elimination in well-defined risk groups like HIV-positive MSM have been promising (CROI 2017 LB137/136). However, high reinfection rates and increased sexual risk behavior may become significant obstacles. Another obstacle is the lack of approval of DAA for the treatment of acute HCV. Indeed, few studies evaluated DAA as acute HCV therapy and included a small numbers of patients (n=17 to 26). Sustained virological response (SVR) rates in these studies varied between 32-59% for sofosbuvir/ ribavirin and 77-100% for sofosbuvir/ledipasvir. The Dutch Acute HCV in HIV study no. 2 (DAHHS2; NCT02600325) was designed to prove that 1. grazoprevir/ elbasvir are effective when given during the acute phase of HCV and 2. treatment can be shortened during acute HCV. Methods: Single-arm prospective open-label multicenter trial in patients with acute HCV genotype 1 or 4. Fifteen hospitals referred patients diagnosed with an acute HCV to 1 of the 9 DAHHS study centers spread across the Netherlands and Belgium. Patients received 8 weeks of grazoprevir/elbasvir 100/50mg QD. Therapy was initiated no later than 26 weeks after the estimated day of infection. The primary endpoint was SVR 12 weeks post-treatment in the intention to treat population. Results: From 02/2016 and ongoing, 110 patients with a recently acquired HCV were evaluated for eligibility. 68 were enrolled, 5 patients never initiated therapy (Fig1). Of the 63 patients that started therapy, 53 reached the primary endpoint at the time of abstract submission. All subjects were MSMwith a mean age of 47 years and all but 3 were HIV-infected. CD4 at baseline in HIV-infected patients was 600/μl (IQR 474-760) and HIV viral load was <50 c/ml in 97%. The genotype 1a/1b/4 distribution was 62/0/38%. Median HCV viral load at study entry was 3.67E5 IU/ml (IQR 1.95E4-2.00E6) and 16% (n=10/63) of HCV infections were a reinfection. SVR12 was observed in 52 of 53 patients (98%; 95%CI 90-100%). One patient relapsed, but without new NS5a/NS3 compared to his baseline virus. One of the 52 patients had a phylogenetically proven new infection. All 13 patients with a baseline viral load >10E6 IU/ml reached SVR12.

129 FUELING THE EPIDEMIC: LOW RATES OF SPONTANEOUS CLEARANCE OF ACUTE HCV COINFECTION Christoph Boesecke 1 , Elena Müller Martinez 1 , Mark Nelson 2 , Patrick Ingiliz 3 , Thomas Lutz 4 , Stefan H. Scholten 5 , Christiane Cordes 6 , Heribert Knechten 7 , Maria Martínez-Rebollar 8 , Christoph D. Spinner 9 , Michael Rausch 10 , Thomas Reiberger 11 , Stefan Mauss 12 , Jürgen K. Rockstroh 1 1 Bonn University Hospital, Bonn, Germany, 2 Chelsea and Westminster Hospital, London, UK, 3 Center for Infectiology, Berlin, Germany, 4 Infektiologikum, Frankfurt, Germany, 5 Praxis Hohenstaufenring, Cologne, Germany, 6 Praxis Cordes, Berlin, Germany, 7 Praxenzentrum Blondelstrasse, Aachen, Germany, 8 Hospital Clinic of Barcelona, Barcelona, Spain, 9 Klinikum rechts der Isar, Munich, Germany, 10 Ärztezentrum Nollendorfplatz, Berlin, Germany, 11 Medical University of Vienna, Vienna, Austria, 12 Center for HIV and Hepatogastroenterology, Düsseldorf, Germany Background: Several clinical trials have shown comparable SVR rates in the treatment of acute hepatitis C (AHC) coinfection with direct acting antivirals (DAA) compared with chronic hepatitis C (HCV) coinfection. In addition, data frommodelling and real life cohorts have shown a reduction in AHC incidence when DAA are used to treat acute HCV coinfection. However, with no DAA currently being licensed for the treatment of AHC and with the high drug prices the question becomes eminent which patients will resolve their AHC infection spontaneously and which patients should be offered timely treatment. Here we evaluate rates of spontaneous clearance of acute HCV coinfection in a large European cohort. Methods: The PROBE-C study is an observational European cohort on AHC in HIV coinfection. Between 2007 and 2016 465 AHC episodes were documented in HIV-infected patients with at least 12 months of follow-up from Austria, Denmark, France, Germany, Great Britain and Spain. Fisher’s exact, chi-square and Mann-Whitney U test were used for statistical analysis.

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CROI 2018