HIV and Hepatitis B Coinfection
Conditions
Keywords
HIV, Hepatitis B, Renal dysfunction, tenofovir alafenamide
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.
Interventions
DRUGTenofovir Alafenamide
Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in renal function | 48 weeks | Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART |
| HBV suppression | 48 weeks | Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment interruptions | 48 weeks | Description of the proportion of patients with treatment changes or interruptions |
| Adverse events | 48 weeks | Evaluation of the proportion of patients with adverse events during therapy, including grade 2 or above transaminases elevations |
| Liver fibrosis change | 48 weeks | Assessment of the proportion of patients with a change in liver fibrosis stage |
Countries
Switzerland
Outcome results
None listed