TY  - JOUR
AU  - Montes, M
AU  - Nelson, M
AU  - Girard, PM
AU  - Sasadeusz, J
AU  - Horban, A
AU  - Grinsztejn, B
AU  - Zakharova, N
AU  - Rivero, A
AU  - Lathouwers, E
AU  - Janssen, K
AU  - Ouwerkerk-Mahadevan, S
AU  - Witek, J
Y2  - 2020/12/18
Y1  - 2014/11/01
SN  - 1758-2652
UR  - http://hdl.handle.net/11343/255812
AB  - INTRODUCTION: We report the SVR12 final analysis of a phase 3 study of telaprevir in combination with peginterferon (P)/ribavirin (R) in HCV-genotype 1, treatment-naïve and -experienced patients with HCV/HIV co-infection (INSIGHT). MATERIALS AND METHODS: Patients receiving stable, suppressive HIV antiretroviral (ARV) therapy, containing atazanavir/ritonavir, efavirenz, darunavir/ritonavir, raltegravir, etravirine or rilpivirine, received telaprevir 750 mg q8h (1125 mg q8h if on efavirenz) plus P (180 µg once-weekly) and R (800 mg/day) for 12 weeks, followed by an additional 12 weeks (non-cirrhotic HCV treatment-naïve and relapse patients with extended rapid viral response [eRVR]) or 36 weeks (all others) of PR alone. Analysis was performed when all patients had completed the follow-up visit of 12 weeks after last planned dose. RESULTS: One hundred sixty-two patients were enrolled and treated (65 efavirenz, 59 atazanavir/ritonavir, 17 darunavir/ritonavir, 17 raltegravir, 4 etravirine). Mean age was 45 years, 78% were male, 92% were Caucasian; mean CD4 count was 687 cells/mm(3). Sixty four patients (40%) were HCV treatment-naïve and 98 (60%) were treatment experienced (29 relapsers, 18 partial responders and 51 null responders). 64% were subtype 1a. 30% had bridging fibrosis (17%) or cirrhosis (13%). 19% of patients discontinued telaprevir, including 9% due to an adverse event (AE), 8% reaching a virologic endpoint and 2% for other reasons (non compliance or not defined). Treatment responses are shown in Table 1. There were no HIV RNA breakthroughs. Most frequently reported (≥20% patients) AEs were pruritus 43%; fatigue 27%; rash 34%, anorectal events 30% and influenza-like illness (25%). Anemia was reported in 15% of patients; grade ≥3 haemoglobin decrease occurred in 2.5% of patients. 6% of patients experienced serious AEs. CONCLUSIONS: In this phase 3 study of HIV-infected, HCV treatment-naïve and -experienced patients, 49% achieved eRVR and 57% reached SVR12. In patients with an eRVR, SVR12 rates were >80%, irrespective of prior treatment history.
LA  - English
PB  - JOHN WILEY & SONS LTD
T1  - Telaprevir combination therapy in HCV/HIV co-infected patients (INSIGHT study): sustained virologic response at 12 weeks final analysis
DO  - 10.7448/IAS.17.4.19626
IS  - Journal of the International AIDS Society
VL  - 17
IS  - 4 Suppl 3
SP  - 90-91
L1  - /bitstream/handle/11343/255812/PMC4224845.pdf?sequence=1&isAllowed=y
ER  -