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
Overview
- Phase
- Phase 2
- Intervention
- Tenofovir Alafenamide
- Conditions
- HIV and Hepatitis B Coinfection
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 24
- Locations
- 8
- Primary Endpoint
- HBV suppression
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Arms & Interventions
Switch
Patients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen
Intervention: Tenofovir Alafenamide
Outcomes
Primary Outcomes
HBV suppression
Time Frame: 48 weeks
Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF
Change in renal function
Time Frame: 48 weeks
Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART
Secondary Outcomes
- Treatment interruptions(48 weeks)
- Adverse events(48 weeks)
- Liver fibrosis change(48 weeks)