| Author | Montes, Marisa | |
| Author | Mark, Nelson | |
| Author | Girard, Pierre Marie | |
| Author | Sasadeusz, Joe | |
| Author | Horban, Andrzej | |
| Author | Grinsztejn, Beatriz | |
| Author | Zakharova, Natalia | |
| Author | Rivero, Antonio | |
| Author | Lathouwers, Erkki | |
| Author | Janssen, Katrien | |
| Author | Mahadevan, Sivi Ouwerkerk | |
| Author | Witek, James | |
| Access date | 2015-07-10T12:09:15Z | |
| Available date | 2015-07-10T12:09:15Z | |
| Document date | 2014 | |
| Citation | MONTES, Marisa et al. Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis. Journal of the International AIDS Society, v. 17, suppl. 3, p. 1-2, 2014. | pt_BR |
| ISSN | 1758-2652 | |
| URI | https://www.arca.fiocruz.br/handle/icict/11203 | |
| Language | eng | pt_BR |
| Publisher | BioMed Central | pt_BR |
| Rights | open access | pt_BR |
| Title | Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.7448/IAS.17.4.19626 | |
| 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. | pt_BR |
| Affilliation | Universidad Autónoma de Madrid. Hospital La Paz. HIV Unit. Internal Medicine. Madrid, Spain. | pt_BR |
| Affilliation | Chelsea and Westminster Hospital. London, UK. | pt_BR |
| Affilliation | Hôpital St. Antoine. Paris, France. | pt_BR |
| Affilliation | Royal Melbourne Hospital. Melbourne, Australia / Alfred Hospital. Melbourne, Australia. | pt_BR |
| Affilliation | Warsaw Medical University. Hospital of Infectious Diseases. Warsaw, Poland. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Saint-Petersburg AIDS Center. St Petersburg, Russian Federation. | pt_BR |
| Affilliation | Hospital Universitario Reina Sofía. Instituto Maimónides de Investigación Biomédica de Córdoba. Cordoba, Spain. | pt_BR |
| Affilliation | Janssen Infectious Diseases BVBA. Beerse, Belgium. | pt_BR |
| Affilliation | Janssen Research & Development LLC. Titusville, PA, USA. | pt_BR |
| Affilliation | Janssen Research & Development LLC. Titusville, PA, USA. | pt_BR |
| Affilliation | Janssen Research & Development LLC. Titusville, PA, USA. | pt_BR |
| Subject | HIV | pt_BR |
| Subject | Hepacivirus | pt_BR |
| Subject | Statistical analysis | pt_BR |
| Subject | Anti-retroviral agents | pt_BR |
| DeCS | HIV | pt_BR |
| DeCS | Hepacivirus | pt_BR |
| DeCS | Análise estatística | pt_BR |
| DeCS | Antirretrovirais | pt_BR |
| e-ISSN | 1758-2652 | |
