The Evaluation of Tenofovir Alafenamide Containing Regimens vs. Tenofovir Disoproxil Fumarate Containing Regimens on Renal Outcomes for Prevention, and Treatment of HIV and/or HBV Treatment: a Systematic Literature Review and Meta-analysis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000194
• EU PAS number:
  EUPAS1000000194
• Study ID:
  1000000194
• Official title and acronym:
  The Evaluation of Tenofovir Alafenamide Containing Regimens vs. Tenofovir Disoproxil Fumarate Containing Regimens on Renal Outcomes for Prevention, and Treatment of HIV and/or HBV Treatment: a Systematic Literature Review and Meta-analysis
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Canada

  China

  France

  Italy

  Japan

  Korea, Republic of

  New Zealand

  Russian Federation

  Spain

  Taiwan

  United Kingdom
• Study description:
  GS-US-120-7229: This was a non-interventional, retrospective cohort, systematic literature review and meta-analysis in participants in randomized controlled trials or observational cohort studies with tenofovir alafenamide (TAF)-containing regimen and Tenofovir disoproxil fumarate (TDF)-containing regimen for prevention or treatment of Human Immunodeficiency Virus (HIV), and/or treatment of Hepatitis B Virus (HBV). ; The primary objective of this study was to compare and quantify the renal outcomes of TAF-containing regimens versus TDF-containing regimens in people who might benefit from pre-exposure prophylaxis (PWBP) and people with HBV, HIV, or HIV/HBV.;
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Study timelines

Date when funding contract was signed

Actual: 31/08/2023

Study start date

Actual: 01/12/2023

Date of final study report

Planned: 02/12/2024

Actual: 24/12/2024

Study protocol

Initial protocol

GS-US-120-7229 Protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable