Abstract PS9/7
STARTVerso 4 Phase III Trial of Faldaprevir Once-daily Plus Peg Interferon Alfa-2a and Ribavirin (PR) in Patients with HIV and HCV Genotype 1 Coinfection: End of Treatment Response (ETR) Print
J.K. Rockstroh1, M. Nelson2, V. Soriano3, K. Arastéh4, J. Guardiola5, S. Bhagani6, J. Mallolas7, C. Tural8, M. Puoti9, P. Ingiliz10, M. Battegay11, M.K. Jain12, K. Marks13, J. Kort14, J.O. Stern14, R. Vinisko14, M. Manero15, D. Dieterich16
1University of Bonn, Bonn, Germany, 2Chelsea and Westminster Hospital, London, United Kingdom, 3Hospital Carlos III, Madrid, Spain, 4EPIMED, Vivantes Auguste-Viktoria Hospital, Berlin, Germany, 5Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 6Royal Free Hospital, London, United Kingdom, 7Hospital Clínic, Barcelona, Spain, 8Hospital Universitari Germans Trias i Pujol, Barcelona, Spain, 9AO Ospedale Niguarda Cà Granda, Milan, Italy, 10Medizinisches Infektiologiezentrum Berlin (MIB), Berlin, Germany, 11Division of Infectious Diseases and Hospital Epidemiology, University Hospital of Basel, Basel, Switzerland, 12UT Southwestern Medical Center, Dallas, United States, 13Weill Cornell Medical College, New York, United States, 14Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, United States, 15Boehringer Ingelheim España S.A, Barcelona, Spain, 16Mount Sinai School of Medicine, New York, United States
Objectives: Assess the efficacy and safety of faldaprevir QD plus PR, and evaluate a 24-week (W) treatment duration in HIV/HCV coinfected patients.
Methods: STARTVerso4 is an open-label, sponsor-blinded study in HCV/HIV coinfected patients who were HCV treatment-naïve (TN) or relapsed after previous HCV therapy. Arm A: faldaprevir 120mg/PR for 24W; Arm B: faldaprevir 240mg/PR for 12W then re-randomisation at W12 to a further 12W faldaprevir/PR or PR alone. At W24, patients with early treatment success (ETS) were re-randomised to stop treatment at W24 or continue PR through W48. Patients without ETS received PR through W48. Patients on HIV protease-based ART or efavirenz were allocated to faldaprevir 120mg or 240mg QD, respectively; those receiving other allowed ART (raltegravir or maraviroc) or no ART were randomised to either dose. The primary endpoint was SVR12. Here we present interim data for patients who had reached the end of treatment (EOT) (planned or not).
Results: Of 308 treated patients (mean age 47 years, 81% male, 83% Caucasian, 14% Black/African American, 29% ≥F3 liver fibrosis, 79% genotype-1a, 66% IL28B-non-CC), 96% used ART. Here we report on 270 patients (88%) who reached EOT, of which 82% achieved ETR (table). ETR was achieved by 160/205 (78%) of TN patients and 62/65 (95%) of relapsers.
HCV RNA undetected n/N (%)Arm A: faldaprevir 120mgArm B: faldaprevir 240mgAll patients (N=270)
 24 weeks (N=106)12 weeks (N=73)24 weeks (N=77)Totala (N=164) 
ETR84/106 (79)64/73 (88)68/77 (88)138/164 (84)222/270 (82)
ETS79/106 (75)60/73 (82)64/77 (83)130/164 (79)209/270 (77)
ETS and ETRb76/79 (96)59/60 (98)62/64 (97)127/130 (98)203/209 (97)
aIncludes patients who discontinued prior to Week 12; bDenominator = patients with ETS. ETR, end of treatment response (HCV RNA undetectable at end of all therapy) ETS, early treatment success (HCV RNA <25 IU/mL detected or undetected at W4 and undetected at W8)
[Table 1]

Most common AEs were nausea (37%), fatigue (34%) and diarrhoea (27%). Study medication was discontinued due to AEs in 7% of patients in Arm A and 8% in Arm B. Serious AEs occurred in 14% and 8% of patients. Haemoglobin ≤8.5 g/dL occurred in 6% of patients.
Conclusions: ETR was achieved by 82% of patients. ETR rate was similar for each faldaprevir dose group. Based on high ETS rates, 38.5% of patients were randomised to stop treatment at W24. Faldaprevir's safety profile was similar to that observed in HCV genotype-1 monoinfected patients.

Assigned speakers:
Jürgen Rockstroh , University of Bonn , Bonn , Germany

Assigned in sessions:
18.10.2013, 14:00-16:00, Parallel Session, PS9, HIV and Hepatitis Co-Infection, Bozar (Plenary Hall)