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TELAPREVIR COMBINATION THERAPY IN HCV/HIV CO-INFECTED PATIENTS (INSIGHT STUDY): SUSTAINED VIROLOGIC RESPONSE AT 12 WEEKS FINAL ANALYSIS
Author
Affilliation
Universidad Autónoma de Madrid. Hospital La Paz. HIV Unit. Internal Medicine. Madrid, Spain.
Chelsea and Westminster Hospital. London, UK.
Hôpital St. Antoine. Paris, France.
Royal Melbourne Hospital. Melbourne, Australia / Alfred Hospital. Melbourne, Australia.
Warsaw Medical University. Hospital of Infectious Diseases. Warsaw, Poland.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.
Saint-Petersburg AIDS Center. St Petersburg, Russian Federation.
Hospital Universitario Reina Sofía. Instituto Maimónides de Investigación Biomédica de Córdoba. Cordoba, Spain.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Research & Development LLC. Titusville, PA, USA.
Janssen Research & Development LLC. Titusville, PA, USA.
Janssen Research & Development LLC. Titusville, PA, USA.
Chelsea and Westminster Hospital. London, UK.
Hôpital St. Antoine. Paris, France.
Royal Melbourne Hospital. Melbourne, Australia / Alfred Hospital. Melbourne, Australia.
Warsaw Medical University. Hospital of Infectious Diseases. Warsaw, Poland.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.
Saint-Petersburg AIDS Center. St Petersburg, Russian Federation.
Hospital Universitario Reina Sofía. Instituto Maimónides de Investigación Biomédica de Córdoba. Cordoba, Spain.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Research & Development LLC. Titusville, PA, USA.
Janssen Research & Development LLC. Titusville, PA, USA.
Janssen Research & Development LLC. Titusville, PA, USA.
Abstract
Abstract
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/mm3. 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.
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