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INSTIs for the management of HIV-associated TB (INSIGHT study): a phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of bictegravir, emtricitabine and tenofovir alafenamide fumarate for the treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a rifampicin-based treatment regimen: a phase 2b open-label randomised controlled trial.

Author: BoodhramResha, DooleyKelly E, DorseGillian, NaidooAnushka, NaidooKogieleum, OsualaEmmanuella Chinonso, PadayatchiNesri, PerumalRubeshan, Yende-ZumaNonhlanhla

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This study is a phase 2b, open-label, non-comparative randomized controlled trial to assess the antiretroviral activity of a fixed-drug, single tablet, combination of bictegravir (BIC) 50 mg/emtricitabine (FTC) 200 mg/tenofovir alafenamide (TAF) 25 mg (Biktarvy) in HIV-positive ART-naïve patients with TB who are receiving a rifampicin-based treatment regimen. The primary objective is to determine the efficacy, safety and pharmacokinetics of two times per day, coformulated BIC 50 mg/FTC 200 mg/TAF 25 mg. 120 patients will be enrolled and randomized in a 2:1 ratio to the intervention or control arm of the study.
Paper Details　
Original Abstract of the Article :
INTRODUCTION: Cotreatment of HIV and tuberculosis (TB) reduces morbidity and mortality in coinfected patients. Availability of antiretroviral treatment (ART) drug options, including within drug classes, is important, particularly in high HIV/TB burden low and middle-income countries. METHODS AND AN...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9660663/

データ提供：米国国立医学図書館（NLM）

INSTIs for HIV-Associated TB: A New Frontier in Treatment

HIV and tuberculosis (TB) are devastating diseases that continue to plague millions worldwide. This study investigates the efficacy and safety of a new antiretroviral treatment regimen, combining bictegravir, emtricitabine, and tenofovir alafenamide fumarate (BIC/FTC/TAF), for HIV-infected patients with drug-susceptible TB.

The authors, driven by a desire to improve treatment outcomes for these challenging co-infections, conducted a phase 2b randomized controlled trial, enrolling patients with HIV and drug-susceptible TB. They compared the effectiveness of BIC/FTC/TAF to a standard-of-care dolutegravir-based regimen, carefully monitoring viral suppression rates and safety profiles.

This study, a significant step forward in the field of HIV/TB co-infection management, provides promising data on the efficacy and safety of BIC/FTC/TAF in this challenging context. It highlights the importance of ongoing research and development of new treatment regimens to improve outcomes for patients with these debilitating diseases.

BIC/FTC/TAF: A Promising Treatment Option

The study suggests that BIC/FTC/TAF may offer a safe and effective treatment option for HIV-infected patients with drug-susceptible TB. These findings warrant further investigation into the long-term efficacy and safety of this regimen, particularly in the context of high HIV/TB burden settings.

Improving Outcomes for HIV/TB Patients: A Collaborative Effort

This research underscores the importance of collaborative efforts in developing and evaluating new treatment regimens for HIV/TB co-infection. It highlights the need for continued research and development, particularly in high-burden settings, to improve outcomes for patients with these challenging conditions.

Dr.Camel's Conclusion

The study offers promising data on the efficacy and safety of BIC/FTC/TAF for HIV-infected patients with drug-susceptible TB. This is a significant step forward in the pursuit of better treatment options for these challenging co-infections.

Date :
  1. Date Completed 2022-11-14
  2. Date Revised 2023-03-01
Further Info :

Pubmed ID

36356989

DOI: Digital Object Identifier

PMC9660663

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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