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CompletedNCT02196064hEPAticUpdated Aug 5, 2015

Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."

An observational study in Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects, sponsored by Fundación Pública Andaluza Progreso y Salud. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-05.

Sponsored by Fundación Pública Andaluza Progreso y Salud · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
519
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

Endpoints

  1. Primary endpoint: Emergence of grade 3-4 TEs/grade 4 TBEs (hepatic toxicity) from baseline to week 48.

  2. Secondary endpoints

    • 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.
02

Conditions studied

  • Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects

Keywords

  • HIV HCV antiretroviral
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 519 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Fundación Pública Andaluza Progreso y Salud is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Inclusion criteria

  • ≥ 18 years old.
  • Chronic HIV-1 infection, as diagnosed on the basis of the presence of serum HIV antibodies detected by EIA and western-blot.
  • Chronic HCV infection as proven by detecting HCV antibodies in plasma, as well as detectable plasma HCV-RNA by PCR.
  • To start a new ART regimen during the study period.

Exclusion criteria

Exclusion Criteria:

  • Subjects with hepatotoxic events in the 2 months previous to Eviplera® treatment.
  • Acute infections or uncontrolled chronic infection in the two months previous to Eviplera® treatment.
  • Concomitant use of any drug with potential drug-drug interaction with Eviplera®.
  • Documented resistance to study drugs.
  • Concomitant therapy including anti-HCV agents, cytotoxic chemotherapy or immunosuppressors during Eviplera® treatment.
  • Subjects taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopped for more than 12 weeks before Eviplera® treatment.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
519 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Incidence of hepatic events

    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.

    Time frame: First 48 weeks of antiretroviral therapy

Secondary outcomes

  1. Comparison of hepatic events between exposed and unexposed to Eviplera®

    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.

    Time frame: First 48 weeks of antiretroviral therapy

  2. Viral Kinetics and Immune response

    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

    Time frame: 48 weeks of antiretroviral therapy

07

Study locations

1 site
  • Fundación Pública Andaluza Progreso y Salud
    Sevilla, 41092, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02196064
Lead sponsor
Fundación Pública Andaluza Progreso y Salud
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Jul 21, 2014
Start date
May 2014
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Aug 5, 2015

Study contacts

Juan Antonio Pineda Vergara
study chair · Hospital Universitario Virgen de Valme
Antonio Rivero Román
study chair · Hospital Universitario Reina Sofía
Dolores Merino Muñoz
principal investigator · Complejo Hospitalario de Especialidades Juan Ramón Jimenez
María José Rios Villega
principal investigator · Hospital Universitario Virgen Macarena
Francisco Téllez Pérez
principal investigator · Hospital La Línea de la Concepción
Inés Pérez Camacho
principal investigator · Hospital de Poniente
Antonio Collado Romacho
principal investigator · Complejo Hospitario Torrecárdenas
Josefa Ruiz Morales
principal investigator · Hospital Universitario Virgen de la Victoria
Marcial Delgado Fernández
principal investigator · Hospital Regional de Malaga
Leopoldo Muñoz Medina
principal investigator · Hospital Universitario San Cecilio
Francisco Vera Méndez
principal investigator · Hospital Santa María de Rosell
Nuria Espinosa Aguilera
principal investigator · Hospitales Universitarios Virgen del Rocío
Iganacio Santos Gil
principal investigator · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Juan González García
principal investigator · Hospital Universitario La Paz
Antonio Vergara de Campos
principal investigator · Hospital Universitario de Puerto Real
Juan Berenguer Berenguer
principal investigator · Hospital Universitario Gregorio Marañón
Federico Pulido Ortega
principal investigator · Hospital 12 de Octubre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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