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NCT Number: NCT03115736

TAF for HIV-HBV With 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.

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Key information

Conditions

HIV and Hepatitis B Coinfection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Kidney Diseases Liver Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale Regionale di Lugano, Lugano, Canton Ticino, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir alafenamide

Drug

Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen

Primary outcomes

  1. Change in renal function

    Time frame: 48 weeks

    Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART

  2. HBV suppression

    Time frame: 48 weeks

    Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF

Secondary outcomes

  1. Treatment interruptions

    Time frame: 48 weeks

    Description of the proportion of patients with treatment changes or interruptions

  2. Adverse events

    Time frame: 48 weeks

    Evaluation of the proportion of patients with adverse events during therapy, including grade 2 or above transaminases elevations

  3. Liver fibrosis change

    Time frame: 48 weeks

    Assessment of the proportion of patients with a change in liver fibrosis stage

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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