Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life Conditions

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the liver toxicity in HIV-infected patients with chronic hepatitis B and/or hepatitis C, who start a new antiretroviral drug regimen, as well as the influence of the degree of pre-existing liver fibrosis on the incidence of liver toxicity.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valme University Hospital
• Collaborators: Complejo Hospitalario de Especialidades Juan Ramón Jimenez; Hospital de la Línea de la Concepción; Hospital Poniente; Hospital Torrecárdenas; Hospital Universitario Reina Sofia; Hospital Universitario Reina Sofia de Cordoba; Hospital Universitario Virgen de la Victoria; Hospital Universitario Virgen Macarena
• Treatments: Anti-Retroviral Agents; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria:

• Older than 18 years

• HIV-1 infection as confirmed by ELISA and western blot

• Chronic HCV infection as confirmed by HCV antibodies in plasma, as well as a positive HCV viral load determined by polymerase chain reaction OR chronic hepatitis B infection as confirmed by HBsAg

• Treatment-naive or pretreated patients who start a new antiretroviral regimen that includes at least one drug that has not been received by the patient before

• At least one week of exposure to new regimen

• Liver biopsy or transient elastometry determination within 12 months prior to treatment initiation

Exclusion Criteria:

• Pregnancy

• Treatment against hepatitis C virus infection

• Presence of opportunistic infections, including tuberculosis, neoplasia, autoimmune diseases. Patients receiving primary or secondary chemotherapy against an opportunistic process are not included.

• Any liver disease of vascular, metabolic, biliary, autoimmune or tumoral origin

• Patients who are not able to provide written informed consent to participate in the study

• Lack of scheduled clinical visits including blood analysis throughout study period