Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients.

Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is different to what is observed in clinical trials in HIV/HCV-coinfected patients.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valme University Hospital
• Collaborators: Complejo Hospitalario de Jaén; Complejo Hospitalario Universitario de Huelva; Fundación de Investigación Biomédica - Hospital Universitario de La Princesa; Hospital Álvaro Cunqueiro; Hospital La Línea; Hospital Poniente; Hospital Regional de Malaga; Hospital Torrecárdenas; Hospital Universitario Central de Asturias; Hospital Universitario de Canarias; Hospital Universitario de Gran Canaria; Hospital Universitario Puerta del Mar; Hospital Universitario Puerto Real; Hospital Universitario Reina Sofia; Hospital Universitario Reina Sofia de Cordoba; Hospital Universitario Virgen de la Arrixaca; Hospital Universitario Virgen de la Victoria; Hospital Universitario Virgen Macarena
• Treatments: Grazoprevir; Ledipasvir; Simeprevir; Sofosbuvir; Velpatasvir

Criteria

Inclusion Criteria:

• Older than 18 years

• HIV infection determined by enzymeimmunoassay and confirmed by Western Blot

• Naïve to treatment including a DAA

• Initiation of triple therapy including a DAA

• Written informed consent to participate in the study and to undergo genetic determinations

Exclusion Criteria:

• Pregnancy

• Any contraindication for the administration of peg-IFN, RBV or the respective DAA

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