A Phase 2 interventional study of Tenofovir Alafenamide in HIV and Hepatitis B Coinfection, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 8 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 2, Interventional, and Treatment
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:
Secondary objectives:
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:
Study Population: eligible patients from all 7 centers of the Swiss HIV Cohort Study will be considered.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 24 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
Patients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen
Drug: Tenofovir Alafenamide
Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen
Change in renal function
Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART
Time frame: 48 weeks
HBV suppression
Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF
Time frame: 48 weeks
Treatment interruptions
Description of the proportion of patients with treatment changes or interruptions
Time frame: 48 weeks
Adverse events
Evaluation of the proportion of patients with adverse events during therapy, including grade 2 or above transaminases elevations
Time frame: 48 weeks
Liver fibrosis change
Assessment of the proportion of patients with a change in liver fibrosis stage
Time frame: 48 weeks
Plan to share: Undecided
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern