Webinar Series: April 20th TB-CHAMP Trial

Mark your calendar for Thursday, April 20th from 08:30 to 09:30 EST (14:30-15:30 CEST, SAST) for a presentation by Dr. Anneke Hesseling, MBChB, MSc, PhD, on the TB-CHAMP Trial

The TB-CHAMP Trial is a phase III cluster randomized, double blind, placebo-controlled, superiority multicenter trial that aims to evaluate the efficacy of levofloxacin versus placebo as preventative therapy against MDR-TB in child and adolescent household contacts.  The TB-CHAMP Trial expects to begin enrolling patients this year.

To join the event as an attendee:

1. Go to https://hms.webex.com/hms/onstage/g.php?MTID=e370d046a7165f1390a6c27226e308b98

2. Click “Join Now”.

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To join the audio conference only:

Call-in toll-free number (US/Canada): 1-877-668-4490

Call-in toll number (US/Canada): 1-408-792-6300

Global call-in numbers: https://hms.webex.com/hms/globalcallin.php?serviceType=EC&ED=538690837&tollFree=0

Toll-free dialing restrictions: https://www.webex.com/pdf/tollfree_restrictions.pdf

Access code: 710 922 884

Programmatic Management of Drug-Resistant Tuberculosis: An Updated Research Agenda

There are numerous challenges in delivering appropriate treatment for multidrug-resistant tuberculosis (MDR-TB) and the evidence base to guide those practices remains limited. This article presents the third updated Research Agenda for the programmatic management of drug-resistant TB (PMDT), assembled through a literature review and survey.

Conclusions state that there is continuity around the priorities for research in PMDT. Coordinated efforts to address questions regarding shorter treatment regimens, knowledge of disease burden without representative data, and treatment for LTBI in contacts of known DR-TB patients are essential to stem the epidemic of TB, including DR-TB.

View the full article here.

WORLD TB DAY 2017

On March 24 we commemorate World TB Day in recognition of the day in 1882 when Dr. Robert Koch announced his discovery of M. tuberculosis. While progress has been made, TB remains one of the top 10 causes of death worldwide 135 years after Dr. Koch’s discovery; in 2015, an estimated 1 million children became ill with TB, and 170,000 children died of TB. Additionally, multidrug-resistant (MDR) TB continues to become an increasingly global issue, with an estimated 480,000 people developing MDR-TB worldwide in 2015.

The theme of this year’s World TB Day is “Unite to End TB”.  Check out the links below to find out what different organizations are doing and for ways you can participate in World TB Day.

WHO World TB Day 2017

Stop TB Partnership 

CDC World TB Day in the U.S. 

Forum of International Respiratory Societies Statement for World TB Day 2017

endTB Partnership Launches Clinical Trial to Target Toughest Strains of TB

Médecins Sans Frontières (MSF), Partners In Health (PIH) and other leading medical organizations have launched a major clinical trial which seeks to revolutionize treatment for the toughest strains of tuberculosis (TB). The first patient started treatment in Georgia earlier this month.

This phase III clinical trial is part of a UNITAID-funded transformative project called endTB, which aims to speed up and expand access to better and shorter treatments for drug-resistant forms of TB. The four-year, US$60 million project, being implemented by PIH, MSF and Interactive Research and Development (IRD), targets 15 countries across three continents. The trial uses bedaquiline and delamanid to find radically shorter (9 months), injection-free, more tolerable treatments for MDR-TB. These new drugs will be combined into experimental new treatments with other oral TB drugs such as clofazimine, linezolid, fluoroquinolones and pyrazinamide.

The endTB project is expected to enroll an estimated 2,600 MDR-TB patients on treatment with the new TB drugs, and 750 patients will take part in a clinical trial across six countries: Georgia, Kazakhstan, Kyrgyzstan, Lesotho, Peru and South Africa.

As stated by Dr. Carole Mitnick, co-principal investigator of the endTB clinical trial from PIH and Harvard Medical School, “Together, PIH and MSF have expanded structures, resources, treatment, evidence, and ambitions for this and other complex diseases affecting poor people. The endTB clinical trial is a natural extension of this decades-long collaboration between two organizations that place priority on expanding access to proven, high-quality interventions among patients who need them, regardless of economic or socio-political situations in which they live.”

Read the full press statement here.

Advocates call on Sequella to provide open access to sutezolid data

In an open letter sent to Sequella on 21 February 2017, TB advocates called attention to the recent agreement between Johns Hopkins University and the Medicines Patent Pool regarding the rights to develop sutezolid in combination for TB, and urged Sequella to provide open access to all existing clinical data for sutezolid to facilitate and accelerate its further clinical development.

“We now appeal to Sequella to act in the interest of public health and provide open access to all existing sutezolid data. In the absence of this data, researchers will have to redo studies, wasting precious resources and time, and delaying both sutezolid’s advancement and urgently needed, better treatment options for TB patients.”

Read the full letter here.

TB community demands WHO include TB on “Priority Pathogens” list

On February 27, the WHO released its first Global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics, which includes 12 families of bacteria that “pose the greatest threat to human health”. The WHO excludes M. tuberculosis from this “Priority Pathogens” list, and has subsequently sparked fierce controversy within the infectious disease and public health communities. A number of organizations have submitted letters of protest to the WHO demanding that M. tuberculosis be included on the list, including the International Union Against Tuberculosis and Lung Disease, the TB Alliance, and the Stop TB Partnership.

Learn more about the TB community’s response through the links below:

The World Health Organization made a big mistake on TB. It must fix it.

Global TB Community Reaction to Exclusion of TB from WHO List of Bacteria in Need of New Antibiotics

 

India plans to expand access to new TB drug

The Delhi High Court’s ruling in the recent landmark lawsuit that granted an 18-year old Indian girl with XDR-TB access to bedaquiline has led health advocates to seek inclusion of delamanid in the Indian government’s Revised National Tuberculosis Control Program. “It is time the government enforces public health safeguards in the patent law and licenses the drug to generic firms so that they can manufacture it for government supplies,” said Paul Lhungdim from the Delhi Network of Positive People.

Read more about the results of the lawsuit and how patient advocacy groups are moving forward here.

Two new drug therapies might cure every form of tuberculosis

Two new drug therapies may have be able to cure all forms of tuberculosis, including the forms that are most difficult to treat.  The treatments, called BPaMZ and BPaL, have the potential to make TB treatment simpler and more effective.  BPaMZ involves taking four drugs once a day, and initial trial results suggest that it cures nearly all cases of ordinary TB in four months, and most people with DR-TB in approximately six months.  BPaL involves taking three drugs once a day, and has so far cured 40 of 69 patients with XDR-TB within six months.  “We will have something to offer every single patient,” stated Mel Spigelman, president of the TB Alliance. “We are on the brink of turning TB around.”

Read the full article here and find out more about the two new regimens.

Shorter regimen for MDR-TB in sight

The TB Alliance conducted a phase two clinical trial aimed at developing and testing a new drug regimen for MDR-TB patients called BPaMZ, which consists of four oral drugs: bedquiline, pretomanid, moxifloxican and pyrazinamide. Over an eight-week period, patients treated with the new BPaMZ regimen cleared M. tuberculosis bacteria from their sputum up to 3.5 times faster than patients who received standard treatments. “The next step is to do a phase three trial, on about 1,200 patients – if we have positive results from that we can apply for regulatory approval from authorities,” stated the TB Alliance’s Dr. Christo van Niekerk.

The TB Alliance presented its findings from the BPaMZ trial at the Conference on Retroviruses and Opportunistic Infections that took place in Seattle in February.

Read more about the trial and next steps here.

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