CROI 2016 Abstract eBook

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Poster Abstracts

582 Response to DAA-Based Regimens in HIV-HCV Coinfected Patients in Real Life, France Lionel Piroth 1 ; LindaWittkop 2 ; Karine LaCombe 3 ; Eric Rosenthal 4 ; Camille Gilbert 5 ; Patrizia Carrieri 6 ; Francois Dabis 7 ; Philippe Sogni 8 ; Dominique Salmon-Ceron 8 ; for the ANRS CO13 HEPAVIH Study Group 1 CHU Dijon, Dijon, France; 2 CHU de Bordeaux, Bordeaux, France; 3 Sorbonne Univs, Paris, France; 4 CHU Nice, Nice, France; 5 INSERM, Bordeaux, France; 6 INSERM, Marseille, France; 7 INSERM U897, ISPED, Univ de Bordeaux, Bordeaux, France; 8 INSERM-APHP, Hosp Cochin, Paris, France Background: Several new oral direct active agent (DAA)-based regimens are available in France for HCV-HIV co-infected patients. We report on efficacy and safety of DAA-based regimen in real-life settings. Methods: HIV-HCV co-infected patients enrolled in the French nationwide ANRS CO13 HEPAVIH cohort were included in this analysis if an oral DAA-based regimen without peg- interferon was initiated before March 1 st 2015 (3-month regimen) or before December 1 st 2014 (6-month regimen) and if the patients had sufficient follow-up data to evaluate DAA efficacy. Treatment success was defined as an undetectable HCV-RNA (<15 UI/mL) at 12 weeks or thereafter (SVR12). Patients with premature treatment stops, detectable HCV-RNA and those who died during treatment were considered as treatment failures. Results: We included 171 patients in 23 clinics with a median age of 53 years (IQR: 50-56), 78%men and 98% on antiretroviral therapy. HIV viral load was <50 copies/mL in 86% and median CD4 was 520 cells/mm 3 (IQR: 319-730). Seventy-three percent of the patients were cirrhotic, and 70% had failed previous anti-HCV treatment. HCV genotype (Gt) distribution was as follows: Gt1, 62%; Gt2, 2%; Gt3, 14%; Gt4, 22%. Overall, we observed SVR12 in 92% of patients (95% CI: 86-97): 92% (CI: 87-97) in cirrhotic and 91% (CI: 83-99) in non-cirrhotic patients. Frequencies of DAA regimen prescribed and corresponding SVR12 are presented in table 1. In a subgroup analysis of 90 cirrhotic patients receiving a regimen without ribavirin, SVR12 for 12 or 24 weeks of treatment were 91% (CI: 71-99) and 93% (CI: 84-98), respectively. Furthermore, in cirrhotic patients receiving a DAA regimen with ribavirin for 12 and 24 weeks, SVR12 rates were 83 (CI: 36-99) and 93% (CI: 77-99), respectively. Of 14 patients with treatment failure, there were 12 relapses, one premature stop for adverse event and one death. Patients with treatment failure had a median age of 55 years (IQR: 53-58), were mainly men (86%); nine of themwere Gt1, three Gt3 and two Gt 4; 71%were cirrhotic. Treatment duration was 24 weeks in 8 of these patients and 12 weeks for the remaining 6 patients. Conclusions: In this real-life prospective French nationwide cohort of HIV-HCV co-infected patients, oral-DAA based regimens showed high efficacy and excellent tolerability. In cirrhotic patients neither a longer duration of treatment nor the addition of ribavirin seemed to have an impact on treatment response. Table 1: Frequencies of prescribed DAA regimens and SVR12, ANRS CO13 HEPAVIH

n (%)

SVR12, % (95% CI)

SOF+DCV+/-Riba SOF+LDV+/-Riba

117 (68)

93 (87-96) 87 (62-96) 88 (74-96) 92 (67-99)

15 (9)

SOF+Riba

26 (15) 13 (8)

SOF+SMV+/-Riba

Legend: DCV: daclatasvir; LDV: ledipasvir; RIBA: ribavirin; SOF: sofosbuvir; SMV: simeprevir; SVR12: sustained virological response 12 weeks after treatment stop; CI: confidence interval.

583 Multidisciplinary Approach for the Treatment of 1155 HCV/HCV-HIV Coinfected Patients Isabelle Poizot-Martin 1 ; Albert Darque 2 ; Isabelle Ravaux 3 ; Amélie Ménard 3 ; Catherine Dhiver 3 ; ChristelleTomei 3 ; Sylvie Brégigeon 1 ; Marc Bourlière 4 ; Isabelle Portal 5 ; Danielle Botta- Fridlund 5 1 APHM Hosp Sainte-Marguerite, Marseille, France; 2 Pharmacie CHU Conception, Assistance Publique Hôpitaux de Marseille, Marseille, France; 3 Inst Hospo Universitaire Méditerranée Infection, Marseille, France; 4 Hosp St Joseph, Marseille, France; 5 CHU Timone, AP-HM, Marseille, France Background: The cost of the new direct-acting antivirals (DAA) against chronic hepatitis C viral infection led the French government to condition their reimbursement to the validation of treatment by a multidisciplinary committee serving in one of the 34 national hepatitis reference centers. This organization allows data concentration on regional scales. We report data and real life efficacy of a large cohort of patients treated by DAAs in south of France. Methods: Analysis included all treatments by DAAs since their approval. Clinical and biological data were collected fromMarch 2014 to July 2015, using a computerized form respecting patient’s anonymity. Physicians were to fill the form to get authorization from hepatitis reference center to start DAA-based treatment. Results: 113 physicians filled out a total of 1155 forms corresponding to 809 men (70%) and 346 women (30%), aging in average 57 ± 10 and 64 ± 12 years, respectively. 508 patients (44%) were treatment-naive and 647 (56%) were pre-treated (76% Peg-IFN+ribavirin, 16% Peg-IFN+ribavirine+protease inhibitor, and 8% DAA) 266 patients (23%) were HIV-coinfected, and 104 patients (9%) had received or were waiting for liver transplantation. In HIV-coinfected patients, 59% had genotype (G) 1 (36% 1a, 8% 1b) and 23% had G4. In HCV mono infected patients, 68% had G1 (27% 1a, 26% 1b) and 9% had G4. G3 repartition was comparable in both populations (17% and 16%, respectively) HIV-coinfected patients were treated at earlier fibrosis stages compared to HCV mono infected (F0-F2: 9% vs 23%; F3: 35% vs 23%; F4: 56% vs 54%, for mono and coinfected patients, respectively). 95% of genotypes 1 and 4 were treated during 12 weeks with sofosbuvir+ledipasvir (63%), sofosbuvir+simeprevir (12%), ombitasvir+paritaprevir/r+dasabuvir (10%), or sofosbuvir+ledipasvir+ribavirin (8%). In G3, duration of treatment was 12 weeks for 75%, and 24 weeks for 25%. Among 12-week treatment, sofosbuvir+daclatasvir and sofosbuvir+ledipasvir+ribavirin accounted for 56% and 26%, respectively. In 24-week treatment, sofosbuvir+daclatasvir with or without ribavirin represented 74% of the associations. Overall sustained virologic response (SVR) rates 4 and 12 weeks after treatment completion were 92% and 92%, respectively. Conclusions: This organization permitted harmonization of treatment by DAAs, in accordance with expert’s recommendations and financial issues. It also permitted to follow a cohort of patients in real life reaching SVR rates comparable to those of clinical studies.

Poster Abstracts

232

CROI 2016