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Saini V, Ammerman NC, Chang YS, Tasneen R, Chaisson RE, et al.
…activity when incorporated into tuberculosis (TB) treatment regimens. We hypothesized that both modifications, i.e., the addition of clofazimine and the replacement of rifampin with high-dose rifapentine, in the first-line regimen for drug-susceptible TB would significantly short…
Xu J, Li SY, Almeida DV, Tasneen R, Barnes-Boyle K, et al.
Novel regimens combining bedaquiline and pretomanid with either linezolid (BPaL regimen) or moxifloxacin and pyrazinamide (BPaMZ regimen) shorten the treatment duration needed to cure tuberculosis (TB) in BALB/c mice compared to that of the first-line regimen and have yielded pro…
Shenzhen Third People's Hospital
…). Despite the availability of effective standard treatment regimens, the current 6-month therapy duration poses challenges in terms of patient adherence, resource allocation, and overall treatment success. In recent years, ultrashort-course regimens for DS-TB have been proposed…
Carr W, Kurbatova E, Starks A, Goswami N, Allen L, et al.
On May 5, 2021, CDC's Tuberculosis Trials Consortium and the National Institutes of Health (NIH)-sponsored AIDS Clinical Trials Group (ACTG) published results from a randomized controlled trial indicating that a 4-month regimen containing rifapentine (RPT), moxifloxacin (MOX), is…
Nicole Salazar-Austin, MD, ScM
While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as e…
Bea S, Lee H, Kim JH, Jang SH, Son H, et al.
Background: Adherence to tuberculosis (TB) drugs is one of the key aspects of global TB control, yet there is a lack of epidemiological evidence on the factors influencing adherence to TB drugs. Thus, this study aimed to explore the adherence and factors associated with adherence…
John Metcalfe, MD, PhD, MPH
The purpose of this study was to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) regimen for drug-susceptible (DS) tuberculosis (TB). This study compared a 3-month rifapentine (RPT)/clofazim…
J Nedelman, M Li, M Olugbosi, R Bruning-Barry, J Ambroso, et al.
…ND and SimpliciTB, clinical trials for drug-susceptible TB, regimens containing pretomanid, pyrazinamide, and other agents (PaZX) had more hepatotoxicity than the standard-of-care regimen of isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE). In Nix-TB and ZeNix, clinical…
Linda J Harrison, Gustavo E Velásquez, Russell R Kempker, Marjorie Z Imperial, Eric Nuermberger, et al.
…context of drug-resistant TB, offers promise for additional regimens for persons with DS-TB, provided they are sufficiently effective and well-tolerated. We spotlight wave 1 of the RAD-TB platform trial (ACTG A5409, NCT06192160) that will investigate new chemical entities for the…
Shanghai Public Health Clinical Center
This study adopts a multicenter, open-label, randomized controlled design, conducted across key designated AIDS diagnosis and treatment hospitals nationwide. It aims to compare the efficacy and safety of the 2HPMZ/2HPM regimen versus the 2HRZE/4HR regimen in treating HIV-associat…
Chabala, Chishala
… low-resource settings, modifications typically involve ART regimens due to constrained drug options. This thesis presents four pharmacokinetics and one clinical study evaluating strategies for HIV/TB co-treatment in children and adolescents receiving rifampicin-based TB therapy,…
Lee H, Bea S, Kim JH, Jeong HE, Jang SH, et al.
…nt drug-susceptible tuberculosis patients who initiated the regimens recommended by the World Health Organization from 2013 to 2018. Adherence was measured using the proportion of days covered (poor [ Results Of 46,818 patients, there were 8% and 11% with poor and moderate adhere…
Naidoo A, Dooley KE, Naidoo K, Padayatchi N, Yende-Zuma N, et al.
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 countri…
Radojka Savic, PharmD, PhD, Kelly Dooley, MD, PhD, Gustavo Velásquez, MD, MPH
…m protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as deter…
Ekaterina V Kurbatova, Kelly E Dooley, Wendy Carr, Jason E Stout, Eric L Nuermberger, et al.
…ized controlled phase 2C trial that compares two four-month regimens, BMZ plus rifabutin (Rb) (2BMZRb/2BMRb) or BMZ plus delamanid (D or DLM) (2BMZD/2BMD), with standard 6-months isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE). All drugs are administered seven days per w…
M E Galvis, G E Gao, M M Salerno, M Whitehead, D Juste, et al.
<sec><title>BACKGROUND</title>In February 2022, the U.S. Centers for Disease Control and Prevention (CDC) recommended a 4-month rifapentine-moxifloxacin based regimen (4-HPMZ) for treating drug-susceptible pulmonary TB. We describe 4-HPMZ implementation, treatment outcomes, and r…
Bryant KE, Yuan Y, Engle M, Kurbatova EV, Allen-Blige C, et al.
…on-inferiority phase 3 clinical trial comparing two 4-month regimens to a standard 6 month regimen for treatment of drug-susceptible tuberculosis (TB) among adolescents and adults with a sample size of 2500 participants. Results Central monitoring utilized primary study data in a…
Oxana Rucsineanu, P. Agbassi, Rosa María Blanca Herrera, Marcus Low, Lindsay McKenna, et al.
… should also be considered when developing new TB treatment regimens, including drug toxicity, time spent in monitoring and overall quality of life while on therapy. We examine the specific use of linezolid in treatment-shortening trials for drug-susceptible TB and propose additi…
Winston CA, Marks SM, Carr W
We estimated direct costs of a 4-month or 6-month regimen for drug-susceptible pulmonary tuberculosis treatment in the United States. Costs were $23,000 per person treated. Actual treatment costs will vary depending on examination and medication charges, as well as expenses assoc…
Otsuka Pharmaceutical Development & Commercialization, Inc.
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid, ethambutol, pyrazinamide (RHEZ) administered for 26 weeks. E…
Imperial MZ, Nahid P, Phillips PPJ, Davies GR, Fielding K, et al.
The version of this article originally published was not open access. This article should have been open access. The error has been fixed, and the article is now open access.
Edgardo A. Ferrán, Eliza Alexander, James Brown, A Gibertoni-Cruz, MCI Lipman, et al.
<h3>Introduction</h3> Recent trial data have demonstrated that both Drug-sensitive (DS) and Drug-resistant (DR) tuberculosis (TB) can be treated effectively with short-course quinolone-containing combination therapy. Current WHO guidance includes using a four-month treatment with…
Rada Savic, PhD
…with or without moxifloxacin as part of multidrug treatment regimens for drug-sensitive pulmonary TB. The proposed study (Study 31 PK/PD) will examine the population pharmacokinetics and pharmacodynamics (PK/PD) of high-dose daily rifapentine with and without moxifloxacin given f…
Reddy KP, Horsburgh CR, Wood R, Fields NF, Girouard MP, et al.
…osis treatment trials failed to show that some 4-month (4m) regimens were noninferior to conventional 6-month (6m) regimens for a composite clinical outcome. Novel shortened regimens may still have important clinical and economic benefits in populations with high loss to follow-u…
V. Guseva, I. А. Vаsilyevа, V. V. Testov
…d drug susceptibility of M. tuberculosis using short-course regimens and a six-month regimen, based on the published data. Subjects and Methods. A systematic search for randomized and quasi-randomized controlled clinical trials was conducted in databases from January 1, 2010 to J…