Dataset Information

Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

The current clinical guidelines do not recommend antiviral therapy for subjects with positive hepatitis B virus (HBV)-DNA and normal alanine transaminase (ALT). In this study, we will assess the safety and efficacy of tenofovir alafenamide fumarate (TAF) in the treatment of adults with positive HBV-DNA and normal ALT, including long-term prognosis.

Methods and analysis

This study is a non-double-blind randomised controlled trial. Study participants will be randomised into the treatment group and the control group. In the treatment group, subjects will receive TAF monotherapy, while those in the control group will receive no antiviral treatment. Subjects will be followed up at the beginning of the study and every 12 or 24 weeks thereafter for review of laboratory findings and to record adverse events. The primary endpoint is the proportion of patients with serum hepatitis B surface antigen loss.

Ethics and dissemination

This study protocol was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University for Human Study (reference number [2019]02-599-01). The results of this study will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT04231565.

SUBMITTER: Wang L

PROVIDER: S-EPMC8375735 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundIn human immunodeficiency virus (HIV) treatment, tenofovir alafenamide (TAF) is associated with greater increases in all fasting cholesterol subgroups compared with tenofovir disoproxil fumarate (TDF). Because lipid abnormalities may contribute to cardiovascular morbidity and mortality, cardiovascular risk assessment is integral to routine HIV care. This post hoc study evaluates the impact of lipid changes on predicted atherosclerotic cardiovascular disease (ASCVD) risk and statin eligibility in treatment-naive adults living with HIV treated with TAF or TDF.MethodsParticipants (N = 1744) were randomized (1:1) to initiate TAF or TDF, each coformulated with elvitegravir/cobicistat/emtricitabine (studies GS-US-292-0104 and GS-US-292-0111). Eligibility for statin therapy and estimated 10-year ASCVD risk among adults aged 40-79 years treated with TAF or TDF for 96 weeks (W96) were analyzed based on American College of Cardiology/American Heart Association Pooled Cohort Equations. Categorical shifts in 10-year ASCVD risk from <7.5% to ≥7.5% by W96 on TAF versus TDF were calculated.ResultsParticipants initiating TAF versus TDF in the overall study population showed small but significant increases in median fasting lipid parameters at W96, including total cholesterol (191 vs 177 mg/dL; P < .001), low-density lipoprotein ([LDL] 119 vs 112 mg/dL; P < .001), and high-density lipoprotein ([HDL] 51 vs 48 mg/dL; P < .001), respectively. At baseline, 18% and 23% on TAF versus TDF had a 10-year ASCVD risk score ≥7.5%, with mean risk scores low overall for TAF versus TDF at baseline (4.9% vs 5.4%; P = .35) and W96 (6.1% vs 6.2%; P = .04). Increases in ASCVD risk from baseline to W96 were driven by both increasing age and changes in total cholesterol (TC) and HDL cholesterol. At W96, TC/HDL ratios (median) were 3.7 for both groups (P = .69). There was no difference between shifts in categorical risk for TAF versus TDF (9% vs 5%; P = .19). Eligibility for high-intensity statin therapy were similar for TAF versus TDF groups (19% vs 21%; P = .47).ConclusionsLipid changes with TAF as part of coformulated regimens do not substantively affect CVD risk profiles compared with TDF.