HIGH EFFICACY OF GRAZOPREVIR/ELBASVIR AMONG HCV GT1, GT4, or GT6 INFECTED PATIENTS WITH HIV CO-INFECTION
Nelson M, Rockstroh J, Mallolas J, Katlama C, Nahass R, Saag M, Sulkowski M, Howe A, Hwang P, Nguyen BY, Wahl J, Barr E, Robertson M, Haber B, Platt H.
Background: We present an integrated analysis of patients with HIV/HCV co-infection enrolled in three Phase 2/3 trials of grazoprevir 100mg (GZR; HCV NS3/4 protease inhibitor) and elbasvir 50mg (EBR; HCV NS5A inhibitor ± ribavirin (RBV).
Methods: HCV-treatment-naive (TN) and/or PEG/RBV treatment-experienced (TE) patients with HIV-coinfection received GZR/EBR ± RBV for 12 or 16 weeks. All patients were on a stable antiretroviral (ARV) regimen (tenofovir or abacavir + lamivudine or emtricitabine + raltegravir, dolutegravir or rilpivirine) with CD4 >200 cells/mm3 and HIV RNA <20 copies/mL, or were HIV treatment-naive with CD4 >500 cells/mm3 and HIV RNA <50,000 copies/mL. The primary efficacy endpoint was sustained virologic response at follow-up week 12 (SVR12; HCV RNA <15 IU/mL).
Results: HIV/HCV co-infected patients comprised 19.4% (298/1536) of the total Phase 2/3 GZR/EBR study population (including 31.3% [277/886] and 3.2% [21/650] of the TN and TE populations, respectively). Efficacy was comparable between HIV/HCV co-infected and HCV mono-infected patients, and between patients receiving RBV-free and RBV-containing regimens (Tables 1 and 2). Six HIV/HCV co-infected TN patients failed to achieve SVR12 for reasons unrelated to study treatment. Virologic failure (primarily relapses) occurred in 10/277 (3.6%) and 1/21 (4.8%) TN and TE patients, respectively. No patient required a change in ARV regimen during treatment with GZR/EBR. The frequency and duration of adverse events (AEs) were comparable in mono-infected and co-infected patients, and no patient discontinued therapy due to a drug-related AE.
Conclusion: Treatment of HIV co-infected patients with GZR/EBR (without RBV) resulted in high efficacy comparable to HCV mono-infected patients for HCV GT1-, GT4-, and GT6- infections. HIV does not increase the risk of failure in patients receiving GZR/EBR for HCV infection.
BMS: Grant Investigator , Research grant
VIIV: Grant Investigator , Research grant
boehringer ingelheim: Grant Investigator , Research grant
abbvie: Grant Investigator , Research grant
gilead: Grant Investigator , Research grant
janssen: Grant Investigator , Research grant
J. Mallolas, MSD, ABBVIE, Janssen: Grant Investigator , Research grant
C. Katlama, None
R. Nahass, None
M. Saag, Gilead Sciences: Investigator , Research support
Merck: Investigator , Research support
BMS: Investigator , Research support
Abbvie: Investigator , Research support
Janssen: Investigator , Research support
M. Sulkowski, None
A. Howe, Merck: Employee and Shareholder , Salary
P. Hwang, Merck: Employee , Salary
B. Y. T. Nguyen, Merck: Employee , Salary
J. Wahl, Merck: Employee and Shareholder , Salary
E. Barr, Merck: Employee and Shareholder , Salary
M. Robertson, Merck: Employee and Shareholder , Salary
B. Haber, Merck: Employee , Salary
H. Platt, Merck: Employee , Salary