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Prospective Cohort Study to Assess the Safety and Efficacy of Replacing Tenofovir Disoproxil Fumarate by Tenofovir Alafenamide in HIV/HBV-coinfected Patients With Mild or Moderate Renal Dysfunction
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 23, 2017
Primary Completion Date
December 5, 2019
Completion Date
December 5, 2019
Last Updated
March 4, 2020
24
ACTUAL participants
Tenofovir Alafenamide
DRUG
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Data Source & Attribution
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