Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort." (hEPAtic)
|ClinicalTrials.gov Identifier: NCT02196064|
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : August 5, 2015
|Condition or disease|
|Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects|
This is a retrospective analysis of the prospective multicenter, observational "HEPAVIR HEPATIC SAFETY Cohort" (NCT01908660), in which the hepatic safety of the three-drug combination TDF/FTC/RPV will be assessed. A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group.
The main objective is to evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
Variables collected within in the cohort:
- Demographic variable: age, sex.
- Variables related to hepatitis C virus-infection: infection route, genotype, grade of hepatic fibrosis and method used for its determination, baseline Child-Pugh index in patients with cirrhosis, previous hepatic decompensations.
- Variables related to HIV-infection: CDC clinical category, HIV viral load, CD4 cell count, previous and new antiretroviral drugs.
- Blood test: AST, ALT platelets, cholesterol, bilirubin, gamma-glutamyltransferase, alkaline phosphatase, creatinine.
- Other variables: alcohol intake, self-reported adverse events, abnormal clinical findings.
- Cause of discontinuing antiviral when applicable.
- Primary endpoint: Emergence of grade 3-4 TEs/grade 4 TBEs (hepatic toxicity) from baseline to week 48.
- Emergence of hepatic adverse events.
- Drug interruptions due to liver toxicity.
- Development of hepatic decompensations.
- CD4 and viral load changes from baseline to week 48.
|Study Type :||Observational|
|Actual Enrollment :||519 participants|
|Official Title:||Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort." hEPAtic Study.|
|Study Start Date :||May 2014|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
Safety of the three-drug combination TDF/FTC/RPV
A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group.
- Incidence of hepatic events [ Time Frame: First 48 weeks of antiretroviral therapy ]Number of patients with grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
- Comparison of hepatic events between exposed and unexposed to Eviplera® [ Time Frame: First 48 weeks of antiretroviral therapy ]
We evaluated the following parameters between subjets exposed and unexposed to Eviplera®
- Incidence of hepatic toxicity
- Incidence of hepatic adverse events.
- Proportion of subjects who interrupt treatment due to liver toxicity according to Eviplera® exposure
We will evaluated this parameters taking account the impact of baseline liver fibrosis/cirrhosis on liver toxicity.
- Viral Kinetics and Immune response [ Time Frame: 48 weeks of antiretroviral therapy ]
Viral kinetics.- We compare the viral load between patients exposed and not exposed with Eviplera.
Immune response.- We compare number of CD4 cells between patients exposed and not exposed with Eviplera
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196064
|Fundación Pública Andaluza Progreso y Salud|
|Sevilla, Spain, 41092|
|Study Chair:||Juan Antonio Pineda Vergara||Hospital Universitario Virgen de Valme|
|Study Chair:||Antonio Rivero Román||Hospital Universitario Reina Sofía|
|Principal Investigator:||Dolores Merino Muñoz||Complejo Hospitalario de Especialidades Juan Ramón Jimenez|
|Principal Investigator:||María José Rios Villega||Hospital Universitario Virgen Macarena|
|Principal Investigator:||Francisco Téllez Pérez||Hospital La Línea de la Concepción|
|Principal Investigator:||Inés Pérez Camacho||Hospital de Poniente|
|Principal Investigator:||Antonio Collado Romacho||Complejo Hospitario Torrecárdenas|
|Principal Investigator:||Josefa Ruiz Morales||Hospital Universitario Virgen de la Victoria|
|Principal Investigator:||Marcial Delgado Fernández||Hospital Regional Universitario de Málaga|
|Principal Investigator:||Leopoldo Muñoz Medina||Hospital Universitario San Cecilio|
|Principal Investigator:||Francisco Vera Méndez||Hospital Santa María de Rosell|
|Principal Investigator:||Nuria Espinosa Aguilera||Hospitales Universitarios Virgen del Rocío|
|Principal Investigator:||Iganacio Santos Gil||Fundación de Investigación Biomédica - Hospital Universitario de La Princesa|
|Principal Investigator:||Juan González García||Hospital Universitario La Paz|
|Principal Investigator:||Antonio Vergara de Campos||Hospital Universitario de Puerto Real|
|Principal Investigator:||Juan Berenguer Berenguer||Hospital Universitario Gregorio Marañón|
|Principal Investigator:||Federico Pulido Ortega||Hospital 12 de Octubre|