HIV and Hepatitis B Coinfection Clinical Trial
Official title:
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.
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