Naive adults

IV TDF: prodrug types. Renal and bone toxicity. TAF dosing. Navigation Toggle navigation. Home Contents Summary of Changes from v. The effect on increased weight was more important for womenunder treatment containing both DTG and TAF [14] , [15] In certain countries, TDF is labelled as mg rather than mg to reflect the amount of the prodrug tenofovir disoproxil rather than the fumarate salt tenofovir disoproxil fumarate.
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Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection

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BIKTARVY® | Clinical Studies in Treatment-Naïve Adults

Study record managers: refer to the Data Element Definitions if submitting registration or results information. Participants: There will be approximately 80 HIVinfected men and women aged 18 years or older who have taken less than or equal to 10 days of prior antiretroviral therapy and have never taken etravirine, dapivirine TMC , or rilpivirine TMC in the main study. There will be approximately 40 subjects who enroll in the main study that will be in the metabolic sub-study and approximately 20 subjects 10 pre-menopausal women and 10 men who enroll in the main study that will be in the genital secretions PK sub-study. For the genital secretions PK sub-study, genital secretion samples will be self-collected throughout the study except for the week 4 study visit where women will have the cervicovaginal sample at time 0 and at 24 hours collected by study staff.
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Initial Regimens: ART-naïve Adult

Includes subjects who discontinued for reasons other than an AE, death, or lack or loss of efficacy, eg, withdrew consent, loss to follow-up, etc. References: 1. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
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Cohen, M. The New Drug Application NDA submitted by Tibotec Pharmaceuticals in July included week data from two ongoing global Phase 3 double-blinded, active controlled, randomized studies. An application for approval also has been submitted to the European Agency for the Evaluation of Medicinal Products and elsewhere, including Canada, Switzerland and Australia. In the pooled analysis, demographics and baseline characteristics were balanced between both arms and randomization was stratified by screening viral load the amount of virus in the blood in both trials, and by nucleos t ide backbone in THRIVE. Rash led to discontinuation in 1 0.
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