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Residual Risk of Disease Progression After Hepatitis C Cure in HIV-HCV Patients
Dominique Salmon-Ceron1; Camille Gilbert2; Philippe Sogni1; Francois Dabis3; Julie Bottero4; Patrick Miailhes5; Lionel Piroth6; Firouzé Bani-Sadr7; Linda Wittkop8; for the the ANRS CO13 Hepavih study group
1INSERM-APHP, Hosp Cochin, Paris, France;2INSERM, Bordeaux, France;3INSERM U897, ISPED, Univ de Bordeaux, Bordeaux, France;4Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Le Kremlin-Bicêtre, France;5CHU Lyon, Lyon, France;6CHU Dijon, Dijon, France;7CHU Reims, Reims, France;8CHU de Bordeaux, Bordeaux, France
Incidence rates of hepatic events and mortality after cure of HCV in HIV-HCV co-infected patients are not yet documented in real-life settings.
We included HIV-HCV co-infected patients with a sustained virological response (SVR24 – negative HCV-RNA ≥6 months after anti-HCV treatment completion) within the French nationwide ANRS CO13 HEPAVIH cohort. Hepatic events were defined as ascites, digestive hemorrhage, bilirubin level >2.05 mg/mL, hepatic encephalopathy and hepatocellular carcinoma (HCC). All events were validated by a medical committee. We estimated incidence rates (95% confidence intervals [CI]) and mortality rates overall, and separately in patients with severe (F3/F4) and mild/no fibrosis (F0/F1/F2). Crude incidence risk ratios (IRR) were assessed using Poisson regression.
We included 324 patients (36%) with SVR24 treatment with peg Interferon + Ribavirin (n=283) or triple therapy with Boceprevir/Telaprevir (n=41) and a median follow-up of 3.6 years. At SVR, median age was 45 years, median CD4 cell count was 450 (IQR 302-624)/mm3, median BMI was 22 kg/m² (IQR 20-24), 7% had an excessive alcohol consumption (>3 glasses of alcohol/day for men and >2 for women), 25% had a severe fibrosis (F3 n=31/F4 n=44) and 45% had a HCV genotype 1. Incidence rate of a first hepatic event was 4.2 per 1,000 person years (PY) (CI: 0.8-7.5) occurring 7 months in median after SVR. Patients with severe fibrosis tended to have a higher risk of first hepatic event compared to patients with mild/no fibrosis (IRR: 5.0 CI: 0.7; 26.3, P=0.10). Hepatic events were: HCC (n=2) and decompensation (n=4). At the time of event, median fibrosis score was 10.3 kPa (IQR 9.0; 16.1) and 60% of these patients had an elastometry value >9.5 kPa.
Death occurred 5.3 years in median after SVR. Overall mortality rate was 4.8 per 1,000 PY (CI: 1.2-8.3), 4.0 (CI: 0.2-7.2) and 5.0 (CI: 0.6-9.4) per 1,000 PY in patients with severe and mild fibrosis, respectively (P=0.63). Causes of death were: HCC (n=2), infection (n=2), cardio-vascular disease (n=2) and unknown (n=1).
Both hepatic events and death after cure were rare after short/mid-term follow-up. A residual risk of hepatic events after hepatitis C cure in HIV-HCV co-infected patients persisted after cure and patients with severe fibrosis tended to have a higher risk for a hepatic event. Our early findings underline the need for long-term follow-up and are in favor of an early access to anti-HCV treatment.