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:
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.”
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.
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.
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.
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.
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.
International Consortium for Trials of Chemotherapeutic Agents in Tuberculosis (INTERTB) Meeting
INTERTB is an international consortium created to evaluate the clinical and bacteriological outcomes of chemotherapeutic agents for the treatment of tuberculosis. The consortium, a not-for-profit charitable organization, is responsible for designing, conducting and analyses of randomized controlled clinical trials to be carried out in countries with a high burden of TB through a substantial network of treatment services and laboratories with which relationships have already been established. This year’s meeting, which is open to the public, will take place onFriday, October 21, 2016 at the Ismaili Centre, 1-7 Cromwell Gardens, London SW7 2SL.
Please RSVP to Dr. Amina Jindani (firstname.lastname@example.org) by September 30.
With support from the Firland Foundation, RESIST-TB investigated mechanisms for accessing drugs prior to regulatory approval and surveyed key providers and advocates on their experience attempting to gain access to new TB drugs through compassionate use or similar pre-approval mechanisms. The findings from this project are detailed in this report, “Monitoring Compassionate Use of New Drugs for Tuberculosis,” available as a PDF here.
This April the co-facilitators leading negotiations for the 2016 United Nations High-Level Meeting on Ending AIDS, the UN Permanent Representatives of Switzerland and Zambia, released the Zero Draft Political Declaration. The Zero Draft contains commitments which aim to end AIDS and TB epidemics by 2030, and will be negotiated and finalized by governments leading up to the High-Level Meeting in New York on June 8-10th. Included in the proposed commitments are the reductions of TB-related deaths among people living with HIV by 75% by 2020, development of new service delivery models to ensure delivery of more integrated services for HIV and TB, and recognition that TB remains the leading cause of death among people living with HIV. To read more about the Zero Draft, visit TB Online here or the UNAIDS website here.