| Author | Nelson, Mark | |
| Author | Amaya, Gerardo | |
| Author | Clumeck, Nathan | |
| Author | Cunha, Clovis Arns | |
| Author | Jayaweera, Dushyantha | |
| Author | Junod, Patrice | |
| Author | Li, Taisheng | |
| Author | Tebas, Pablo | |
| Author | Stevens, Marita | |
| Author | Buelens, Annemie | |
| Author | Vanveggel, Simon | |
| Author | Boven, Katia | |
| Author | ECHO Study Group | |
| Author | THRIVE Study Group | |
| Access date | 2018-11-16T14:51:06Z | |
| Available date | 2018-11-16T14:51:06Z | |
| Document date | 2012 | |
| Citation | NELSON, Mark. et al. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. Journal of antimicrobial chemotherapy, v. 67, n. 8, p. 2020-2028, 2012. | pt_BR |
| ISSN | 0305-7453 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/30058 | |
| Description | Presente no ECHO Study Group: Beatriz Grinsztejn (Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil). | pt_BR |
| Language | eng | pt_BR |
| Rights | restricted access | pt_BR |
| Title | Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials | pt_BR |
| Type | Article | |
| DOI | 10.1093/jac/dks130 | |
| Abstract | OBJECTIVES:
The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared in treatment-naive, HIV-infected adults with concurrent hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in the pooled week 48 analysis of the Phase III, double-blind, randomized ECHO (NCT00540449) and THRIVE (NCT00543725) trials.
METHODS:
Patients received 25 mg of rilpivirine once daily or 600 mg of efavirenz once daily, plus two nucleoside/nucleotide reverse transcriptase inhibitors. At screening, patients had alanine aminotransferase/aspartate aminotransferase levels ≤5× the upper limit of normal. HBV and HCV status was determined at baseline by HBV surface antigen, HCV antibody and HCV RNA testing.
RESULTS:
HBV/HCV coinfection status was known for 670 patients in the rilpivirine group and 665 in the efavirenz group. At baseline, 49 rilpivirine and 63 efavirenz patients [112/1335 (8.4%)] were coinfected with either HBV [55/1357 (4.1%)] or HCV [57/1333 (4.3%)]. The safety analysis included all available data, including beyond week 48. Eight patients seroconverted during the study (rilpivirine: five; efavirenz: three). A higher proportion of patients achieved viral load <50 copies/mL (intent to treat, time to loss of virological response) in the subgroup without HBV/HCV coinfection (rilpivirine: 85.0%; efavirenz: 82.6%) than in the coinfected subgroup (rilpivirine: 73.5%; efavirenz: 79.4%) (rilpivirine, P = 0.04 and efavirenz, P = 0.49, Fisher's exact test). The incidence of hepatic adverse events (AEs) was low in both groups in the overall population (rilpivirine: 5.5% versus efavirenz: 6.6%) and was higher in HBV/HCV-coinfected patients than in those not coinfected (26.7% versus 4.1%, respectively).
CONCLUSIONS:
Hepatic AEs were more common and response rates lower in HBV/HCV-coinfected patients treated with rilpivirine or efavirenz than in those who were not coinfected. | pt_BR |
| Affilliation | Chelsea and Westminster Hospital/St Stephen's Centre. London, UK. | pt_BR |
| Affilliation | Centro Médico Puerta de Hierro/Universidad de Guadalajara. Departamento de Enfermedades Infecciosas. Jalisco, México. | pt_BR |
| Affilliation | Saint-Pierre University Hospital. Clinic of Infectious Diseases. Brussels, Belgium. | pt_BR |
| Affilliation | Centro Médico São Francisco. Curitiba, Brasil. | pt_BR |
| Affilliation | University of Miami. Division of Infectious Diseases. Miami, FL, USA. | pt_BR |
| Affilliation | Clinique Medicale du Quartier Latin. Montreal, Canada. | pt_BR |
| Affilliation | Beijing PUMC Hospital. Beijing, China. | pt_BR |
| Affilliation | University of Pennsylvania Hospital. Division of Infectious Diseases. Philadelphia, PA, USA. | pt_BR |
| Affilliation | Janssen Infectious Diseases BVBA. Beerse, Belgium. | pt_BR |
| Affilliation | Janssen Infectious Diseases BVBA. Beerse, Belgium. | pt_BR |
| Affilliation | Janssen Infectious Diseases BVBA. Beerse, Belgium. | pt_BR |
| Affilliation | Janssen Research & Development LLC. Titusville, NJ, USA. | pt_BR |
| Subject | TMC278 | pt_BR |
| Subject | Efavirenz | pt_BR |
| Subject | Hepatitis | pt_BR |
| Subject | Hepatic safety | pt_BR |
| Subject | Non-nucleoside reverse transcriptase inhibitors | pt_BR |
| Subject | HBV | pt_BR |
| Subject | HCV | pt_BR |
| Embargo date | 2028-08-30 | |
