Telaprevir combination therapy in HCV/HIV co-infected patients (INSIGHT study): sustained virologic response at 12 weeks final analysis.
BACKGROUND
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).


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.
HIV Unit, Internal Medicine, Hospital La Paz, Universidad Autónoma de Madrid, IdiPAZ, Madrid, Spain.
Marisa
M
Montes
Chelsea and Westminster Hospital, London, UK.
Mark
M
Nelson
Hôpital St Antoine, Paris, France.
Pierre Marie
PM
Girard
Royal Melbourne and Alfred Hospitals, Melbourne, Australia.
Joe
J
Sasadeusz
Hospital of Infectious Diseases, Warsaw Medical University, Warsaw, Poland.
Andrzej
A
Horban
STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro, Brazil.
Beatriz
B
Grinsztejn
Saint-Petersburg AIDS Center, St Petersburg, Russian Federation.
Natalia
N
Zakharova
Hospital Universitario Reina Sofía-IMIBIC, Cordoba, Spain.
Antonio
A
Rivero
Janssen Infectious Diseases BVBA, Beerse, Belgium.
Erkki
E
Lathouwers
Janssen Research & Development LLC, Titusville, USA.
Katrien
K
Janssen
Janssen Research & Development LLC, Titusville, USA.
Sivi
S
Ouwerkerk-Mahadevan
Janssen Research & Development LLC, Titusville, USA.
James
J
Witek