TAF for HIV-HBV With Renal Dysfunction

NCT ID: NCT03115736

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-23
• Study Completion Date: 2019-12-05

Brief Summary

The investigators aim at describing changes in renal glomerular and tubular function with after the switch from TDF to TAF in HIV/HBV-coinfected patients with mild to moderate renal dysfunction and to assess the virological efficacy of TAF on HBV infection.

The study will include HIV/HBV-coinfected participants of the Swiss HIV Cohort Study (SHCS) who are under active care and have been on a stable, TDF-containing ART regimen for at least 6 months. Only patients with an estimated glomerular filtration rate (GFR) between 30 ml/min and 90 ml/min will be included. All individuals who agree to participate will be switched from a TDF-containing ART regimen to a TAF-containing triple ART regimen at week 0 and will be followed for 48 weeks after the treatment change.

Detailed Description

Rationale:

Tenofovir alafenamide (TAF) has been shown to cause less renal complications than tenofovir disoproxil fumarate (TDF) while having the same virological efficacy against HIV and HBV infections. In a recent study from the USA and Japan, over 90% of HIV/HBV-coinfected individuals had a suppressed HBV viral load 48 weeks after TDF was replaced by TAF. Thus, TAF might be a valuable treatment option for HIV/HBV-coinfected individuals with TDF-toxicity, especially in the context of resistance to lamivudine and entecavir. However, the safety and efficacy of TAF has not been evaluated to date in HIV/HBV-coinfected patients with renal dysfunction.

Primary objectives:

• To evaluate changes in glomerular and tubular renal function after switch from TDF to TAF in HIV/HBV coinfected patients with renal dysfunction
• To assess the HBV virological efficacy of TAF in HIV/HBV coinfected patients with renal dysfunction switching from TDF to TAF.

Secondary objectives:

• To assess the percentage of and reasons for treatment interruptions
• To describe toxicity events including liver-related complications
• To evaluate changes in liver fibrosis

Intervention:

In eligible patients willing to participate and who have signed an informed consent TDF will be replaced by TAF on day 1 of the study.

Products:

• Tenofovir alafenamide/emtricitabine (TAF/FTC) Dose: one tbl. once per day in addition to at least one third compound OR
• Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) Dose: one tbl. once per day

Study Population: eligible patients from all 7 centers of the Swiss HIV Cohort Study will be considered.

Conditions

HIV and Hepatitis B Coinfection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Switch

Patients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen

Group Type: EXPERIMENTAL

Tenofovir Alafenamide

Intervention Type: DRUG

Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen

Interventions

Tenofovir Alafenamide

Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• HIV/HBV-coinfection
• Suppressed HIV-viremia (<200 cp/ml)
• On TDF-containing ART since at least 6 months
• eGFR > 30 ml/min and <90 ml/min
• Written informed consent

Exclusion Criteria

• Study drug considered by the treating physician not a valid option for the patient
• Pregnancy
• Decompensated liver cirrhosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Wandeler, MD MSc

Role: STUDY_CHAIR

Insel Gruppe AG, University Hospital Bern

Locations

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Cabinet médical Chave-Crottaz-Roggerto

Lausanne, Canton of Vaud, Switzerland

Ospedale Regionale di Lugano

Lugano, Canton Ticino, Switzerland

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Vaude, Switzerland

Klinik für Infektiologie und Spitalhygiene, Universitätspital Basel

Basel, , Switzerland

Inselspital

Bern, , Switzerland

Department of Infectious Diseases, Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Klinik für Infektionskrankheiten & Spitalhygiene, Universitätsspital Zürich

Zurich, , Switzerland

Countries

Switzerland

References

Surial B, Beguelin C, Chave JP, Stockle M, Boillat-Blanco N, Doco-Lecompte T, Bernasconi E, Fehr J, Gunthard HF, Schmid P, Walti LN, Furrer H, Rauch A, Wandeler G; and the Swiss HIV Cohort Study. Brief Report: Switching From TDF to TAF in HIV/HBV-Coinfected Individuals With Renal Dysfunction-A Prospective Cohort Study. J Acquir Immune Defic Syndr. 2020 Oct 1;85(2):227-232. doi: 10.1097/QAI.0000000000002429.

Reference Type: DERIVED

PMID: 32925387 (View on PubMed)

Other Identifiers

INSEL-HINF-2017-1

Identifier Type: -

Identifier Source: org_study_id