Access to HCV triple therapy with telaprevir or boceprevir in real-life setting in HIV-HCV co-infected patients - ANRS CO13 Hepavih Cohort (France)

Background: Data concerning the use of HCV direct-acting protease inhibitors (PI) in HIV/HCV co-infected patients in a real life setting are scarce. Access to therapy and early use were evaluated in a prospective French cohort of HIV/HCV co-infected patients.
Methods: Data of HCV genotype 1/HIV co-infected patients, followed-up from 01/2011 to 02/2013 were analysed. The rate of tritherapy uptake with telaprevir (TPV), boceprevir (BOC) or other PI + Peg-IFN-Ribavirin was estimated among patients who respected criteria for tritherapy initiation. Rapid virological response (RVR) and extended RVR (eRVR) were defined as an HCV-RNA < 15UI/mL at week 4, and at weeks 4 and 12 after PI initiation, respectively. A severe anemia was defined as Hb < 9 g/dL or a 4.5 g/dL decrease.
Results: Among 300 eligible patients, 93 (31%) initiated tritherapy (TPV n=62, BOC n=23, other n=8), among whom 31 in clinical trials. 24% of them were naïve for anti-HCV treatment, 13% were relapsers and 63% non-responders. Median HCV-RNA at treatment initiation was 6.0 log10 and 44% were cirrhotic. Median CD4 cell count was 593/mm3 and 93% had undetectable HIV RNA. All patients were under ART.At least one contra-indication to treatment initiation was reported in 34% of non-treated patients: psychiatric disorders (9.9%), current active IV drug use (7.9%), cardiovascular diseases (4.3%), thrombocytopenia < 50 000/mm3 (2.6%), CD4< 100/mm3 (2.6%), decompensated cirrhosis or hepatocellular carcinoma (2.5%), excessive alcohol consumption (>5 units/d) (2.1%), anemia < 10 g/dl (1.3%), renal impairment (creatinine >200 mmol/l) (1.2%). Among treated patients with a follow-up >1 month, a RVR occurred in 65% for TPV and 27% for BOC and an eRVR in 63% of TPV and 14% of BOC treated patients. By W4, severe anemia was observed in 24% of patients (28% for telaprevir and 10% for boceprevir) and rashes were reported in 8% of TPV treated patients.
Conclusions: More than 34% of HCV genotype 1- HIV co-infected patients included in this French cohort initiated an anti-HCV tritherapy under real-life settings with a high rate of RVR. However, the frequency of anemia underlines the need of an intensive monitoring in this population.
Keywords: hepatitis C, telaprevir, boceprevir, HIV HCV co-infection

I. Poizot Martin1, L. Merchadou2, P. Carrieri3, P. Miailhes4, E. Billaud5, S. Dominguez6, F. Dabis2, P. Sogni7, M.-A. Loko2, D. Salmon8, ANRS CO13 Hepavih Cohort (France)
1Marseille Hospital, Marseille, France, 2INSERM U897/ ISPED, Bordeaux Segalen University, Bordeaux, France, 3INSERM U912, Aix Marseille University, Marseille, France, 4CHU Lyon, Lyon, France, 5CHU Nantes, Nantes, France, 6Henri Mondor Hospital, Créteil, France, 7Cochin Hospital, Paris, France, 8Cochin Hospital, Internal Medicine and Infectious Diseases, Paris, France