Abstract Body

Background: SVR12 rates >90% have been achieved with the interferon-free 3 direct-acting antiviral regimen (3D) of co-formulated ABT-450 (identified by AbbVie and Enanta)/ritonavir/ombitasvir with dasabuvir +/- RBV in HCV genotype (GT) 1 mono-infected patients. We assessed HCV RNA viral suppression over time in HCV/HIV-1 co-infected patients treated with 3D+RBV and in mono-infected patients treated with 3D+/-RBV.

Methods: Data from the pooled population of HCV GT-1 mono-infected patients from six phase 3 trials of 3D+/-RBV for 12 weeks or 24 weeks (N=2053) and the HCV/HIV-1 co-infected patients from the Phase 2 TURQUOISE-I trial of 3D+RBV for 12 or 24 weeks (N=63) were included. Patients who experienced non-virologic failure were excluded from the efficacy analysis (N=26 mono-infected; N=1 co-infected). HCV RNA was determined using the Roche COBAS TaqMan RT-PCR assay; lower limit of quantification (LLOQ) =25 IU/ml. SVR12 rates were analyzed according to the first week HCV RNA〈ˆLLOQ was attained.

Results: Mono- and co-infected patient groups were well matched for IL28B non-CC GT (78% [1607/2053] mono-infected; 81% [51/63] co-infected) and proportion with cirrhosis (19% [384/2053] mono-infected; 19% [12/63] co-infected). More co-infected than mono-infected patients were black (24% [15/63] vs 6% [123/2053], respectively). Most patients achieved HCV RNA〈ˆLLOQ by week 2, regardless of mono- or co-infection (1652/2027 [81%] mono-infected, 57/62 [92%] co-infected); stratifying this by cirrhosis state yielded 283/374 (76%) for cirrhotic and 1369/1653 (83%) for non-cirrhotic mono-infected patients and 11/12 (92%) for cirrhotic and 46/50 (92%) for non-cirrhotic co-infected patients. By week 4, the 5 remaining co-infected patients who were not suppressed at week 2 had HCV RNA < LLOQ. Two out of three co-infected patients who achieved HCV RNA〈ˆLLOQ at week 2 and did not achieve SVR12 had documented HCV re-infection. Similar to mono-infected patients, SVR12 rates (despite documented re-infection) in co-infected patients were high (89-100%), regardless of time of initial HCV viral suppression (Figure). The overall safety profile was similar for mono- and co-infected patients.

Conclusions: Both HCV mono- and HCV/HIV-1 co-infected patients achieved rapid HCV viral suppression with 3D+/-RBV treatment. SVR12 rates were high regardless of time of first virologic response.

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*Virologic failures occurring in 2 patients appear to have resulted from reinfection based on analyses of baseline and virologic failure samples