TB-PRACTECAL Recruits First Patient

The Médecins Sans Frontières (MSF) sponsored clinical trial, TB-PRACTECAL, has begun. The trial’s first patient was randomized and started treatment on January 17, 2017 at the trial site in Nukus, Uzbekistan. In parallel to enrollment at the Nukus study site, additional sites are being upgraded and readied for recruitment in the KwaZulu-Natal province in South Africa by THINK (TB & HIV Investigative Network), in Minsk, Belarus, and in Tashkent, Uzbekistan. TB-PRACTECAL is a multi-centre, open label, multi-arm, randomized controlled phase II-III trial that aims to evaluate short treatment regimens containing bedaquiline and pretomanid in combination with existing anti-TB drugs for the treatment of MDR and XDR-TB.

More information about the trial can be found at:
https://clinicaltrials.gov/ct2/show/NCT02589782?term=TB-PRACTECAL&rank=1
https://www.msf.org.uk/content/tb-practecal

WHO Welcomes New Agreement Between Medicines Patent Pool and Johns Hopkins University on the Development of Sutezolid for TB Treatment

The World Health Organization welcomes a new licensing agreement between the Medicines Patent Pool (MPP) and Johns Hopkins University to facilitate the clinical development of the TB drug candidate sutezolid. Phase I trials indicated that sutezolid has action mechanisms similar to those of linezolid, the commercially-available oxazolidinone antibiotic in the same class, but that sutezolid is more potent and less toxic than linezolid. Although sutezolid reached Phase IIa clinical development, there have been no advances since 2013.

“The MPP-John Hopkins University agreement is an extraordinary step as it seeks to jump-start currently stalled development on a compound that showed promise in early stage trials,” said Mario Raviglione, Director of the Global TB Programme at the World Health Organization (WHO). “The current scarcity of treatment options is threatening to derail the WHO’s global targets to slash TB deaths by 90% by 2030. We are in urgent need of new and better combination regimens, especially for patients with MDR-TB, and the inclusion of sutezolid might bring great benefit.

“Sutezolid has been considered a promising investigational treatment that, if further developed in combination with other drugs, could be used to more effectively treat both drug-sensitive and drug-resistant TB in patients,” added Dr Christian Lienhardt, Team Leader, Research for TB Elimination, WHO Global TB Programme. “We commend the Medicines Patent Pool for its new commitment to facilitate treatment options for TB patients.”

Indian Girl with XDR-TB Wins Access to Bedaquiline

India’s Ministry of Health agreed to grant access to bedaquiline to an 18-year old girl suffering from extremely drug-resistant tuberculosis (XDR-TB). The girl, who was diagnosed with XDR-TB in 2013, was previously unable to receive treatment with bedaquiline due to stringent restrictions on the new drug’s use in India.  The girl’s father brought her predicament to court, asking that the Delhi High Court direct the government to administer the drug immediately to his daughter.  On January 18th, 2017, following a month-long deliberation process that has been closely followed by public health experts across the globe, the High Court decided to grant the girl access to bedaquiline.

Read more about the lawsuit and hearing here.

Webinar | The PHOENIx MDR-TB Trial | Thursday, January 19th at 08:30 EST (13:30 CET, 14:30 SAST)

Mark your calendar for Thursday, January 19th from 08:30 to 09:30 EST (13:30-14:30 CET, 14:30-15:30 SAST) for a presentation from Dr. Gavin Churchyard, MBBCh, MMED, FCP (SA), PhD, entitled “Protecting MDR-TB and XDR-TB Affected Households: The PHOENIx MDR-TB Trial”.
The Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx) Study, is a phase III trial in development by the ACTG and IMPAACT networks aiming to asses the efficacy of six months of daily delamanid versus six months of isoniazid preventive therapy in high-risk household contacts of adult pulmonary MDR-TB cases.

Connection details forthcoming. 

 

TB Drug Monographs: A Resource to Support the Monitoring and Safe Use of Anti-Tuberculosis Drugs and Second Line Treatment for MDR-TB

This site provides a great resource as a guideline for monitoring for adverse effects during the treatment of MDR-TB.  This guideline is not a treatment guide or a guide for monitoring the progress of treatment.  Advice is based on best available evidence and when this is poor, expert consensus.  These monitoring guidelines were developed in the context of the UK where treatment within the NHS is standard and there the tests advised are readily available.

A link to this site can also be found listed on our Training Resources page.

Webinar | The V-QUIN MDR Trial | Thursday, November 3rd at 08:00 EST (13:00 CET)

Update: The link to download Dr. Greg Fox’s presentation can be found here.

On Thursday, November 3rd from 08:00 – 09:00 EST (14:00 – 15:00 CET) Dr. Greg Fox hosted a webinar on the V-QUIN MDR Trial. The webinar provided an update on the trial design, start-up, study sites, target population, and anticipated timeline of the V-QUIN MDR Trial. The V-QUIN Trial is a randomized controlled trial that aims to evaluate six months of daily levofloxacin versus six months of placebo as preventative therapy among household contacts of patients with MDR-TB. At this time, the V-QUIN Trial is only enrolling adults aged 15 years and above, with the hopes of enrolling children and adolescents at a later stage.  The V-QUIN Trial is currently enrolling participants in Vietnam.

 

NEW: Drug-Resistant Tuberculosis Working Group at the Union Meeting

RESIST-TB is excited to announce the creation of the Drug-Resistant Tuberculosis Working Group (DR-TB WG); the first meeting of this WG will take place during the Union Meeting, at 14:45-15:45 on Wednesday, October 26, 2016. This WG will gather and share information to help accelerate scale-up of evidence-based DR-TB policy and practice.  The WG will address a series of objectives focused on DR-TB and will collaborate with GDI to track progress towards End TB Global Plan DR-TB goals. In order to focus on this important new WG, RESIST-TB will not have a separate Annual Meeting at the Union Meeting, but will incorporate updates on its activities into the DR-TB WG meeting agenda.

Webinar | ACTG 5343 Study

On Tuesday, September 13th from 08:30 to 9:30 EST, Dr. Kelly Dooley, MD PhD, gave a presentation on the ACTG 5343 Study.  The ACTG 5343 study, conducted in South Africa and Peru, is a trial of the safety, tolerability, and pharmacokinetics of bedaquiline and delamanid, alone and in combination, among participants taking multidrug treatment for drug-resistant pulmonary tuberculosis
The link to download Dr. Dolley’s presentation can be found here.

WHO shorter regimen for MDR-TB announced.

 The World Health Organization (WHO) announced new recommendations for a shortened treatment regimen for multi-drug resistant tuberculosis (MDR-TB) patients – nine months compared to the current 24-month treatment standard used worldwide.
Shorter regimen for patients
At less than US$ 1000 per patient, the new treatment regimen can be completed in 9–12 months. The shorter regimen is recommended for patients diagnosed with uncomplicated MDR-TB, for example those individuals whose MDR-TB is not resistant to the most important drugs used to treat MDR-TB (fluoroquinolones and injectables), known as “second-line drugs”. It is also recommended for individuals who have not yet been treated with second line drugs.

Rapid diagnostic test to identify second-line drug resistance
A newly recommended diagnostic test for use in national TB reference laboratories– called MTBDRsl – is a DNA-based test that identifies genetic mutations in MDR-TB strains, making them resistant to fluoroquinolones and injectable second-line TB drugs.This test yields results in just 24-48 hours, down from the 3 months or longer currently required. The MTBDRsl test is a critical prerequisite for identifying MDR-TB patients who are eligible for the newly recommended shorter regimen, while avoiding placing patients who have resistance to second-line drugs on this regimen (which could fuel the development of extensively drug-resistant TB or XDR-TB).

Link to Factsheet
Link to News Release

Updated Research Agenda for the Programmatic Management of Drug-Resistant Tuberculosis

On May 25, PLoS One published an article by Dr. Carole Mitnick et al. on the updated research agenda for the programmatic management of drug-resistant tuberculosis (PMDT). The authors built upon previous PMDT publications by reviewing resources including guidelines, documents, websites and publications published between January 2008 and August 2013 that cited the last research agenda released in 2008. Resources reviewed spanned five main research categories: Laboratory Support, Epidemiology, Programmatically Relevant Research, Treatment Strategy, and Management of Contacts. Results showed that there was continuity around the priorities for research in PMDT that could help fill longstanding evidence gaps barring expanded treatment access.  Identified priorities specifically highlighted the importance of increased coordinated efforts to address questions regarding: shorter treatment regimens; knowledge of disease burden without representative data; and treatment for latent TB infection in household contacts of known drug-resistant (DR-TB) patients. Addressing such questions is essential to stem the epidemic of TB, including DR-TB.

Read the open-access article here.