2016 Stakeholders Association Meeting
TB Alliance held its annual Stakeholders Association (SHA) meeting in Liverpool, United Kingdom on October 24, 2016, ahead of the 47th Union World Conference on Lung Health. Over 120 stakeholders attended to hear the latest information from TB Alliance and its partners in the development and delivery of improved TB drug regimens. This year, key focus areas included trial results from the NC-005 and Nix-TB studies, progress in the introduction of improved child-friendly medicines, and the impact new TB regimens can have on patients and communities.
The 2016 meeting was opened by re-elected Stakeholders Association President Karl Hofmann, of PSI. He provided an overview of the last three years of his SHA President tenure by discussing the progress TB Alliance has made and the challenges it has overcome. Now, based on the new data from clinical trials, there are new possibilities in terms of impacting the TB epidemic.
Willo Brock, Senior Vice-President of External Affairs, discussed updates to the organizational structure of the SHA, including the new Association’s guidelines. He noted that, in addition to the President’s re-election, Paul Sommerfeld was appointed for a second term as Secretary. Two new Community Representatives were endorsed to join the SHA for a three-year term. Sarah Mulera and Maurine Murenga, both from Kenya, joined the SHA as advocates and representatives from a TB-affected population.
A Patient and Community Perspective on New TB Treatments
Steve Bradley, UK-based TB survivor and advocate with TB Alert, shared his personal story of struggling with TB. After delayed diagnosis, Steve was given the standard first-line treatment, leaving him blind and without feeling in his legs. Explaining the impact of these toxic drugs on the lives of TB patients, he implored the audience to focus on the development of better TB drugs and to engage with the affected TB population throughout the development process. He made a clear statement that this was not just needed because of drug resistance but also because of the long duration and poor tolerability of the current first-line drugs.
Maurine Murenga, SHA Community Representative, shared her personal experience with TB in her own family and community in Kenya. She said, “TB’s mother is stigma, and its grandmother is human rights violations.” Ms. Murenga explained the importance of engagement with affected communities when studying new drugs, bringing in community members as partners—not just participants—in clinical trials. Maurine explained that the success of clinical trials can depend on the community’s acceptance, and trials should be planned accordingly. She shared an anecdote about a community rejecting a clinical trial because the pill being given was blue. In that community, “blue pills” were used in the sex trade, and carried stigma. This inhibited community acceptance of the trial, an obstacle that could have been prevented had the community been consulted earlier in the planning process.
The State of the TB Alliance
Dr. Mel Spigelman, President and CEO of TB Alliance, discussed the dawn of a new era of TB treatment, based on the exciting results from the Phase 2b trial NC-005, for drug-sensitive and multi-drug resistant TB, and interim results from the Nix-TB trial focusing on a cure for XDR-TB patients. The BPaMZ regimen, which was tested in NC-005, produced the fastest rate of culture conversion ever seen for a TB drug regimen. In Nix-TB, Dr. Spigelman updated that 33 participants with XDR-TB had successfully completed treatment with a six-month, three-drug regimen, and were being followed-up with no relapses reported to date. An additional 13 patients are still on the study treatment. Further information on Nix-TB and NC-005 was provided at a scientific symposium held at the Union Conference later in the week as well as during the late-breaker session at the plenary session of the final day of the IUATLD conference. Dr. Spigelman reinforced TB Alliance’s commitment to working with stakeholders moving forward, and thanked the group for its ongoing commitment and support.
View the slides from Mel Spigelman's presentation
Childhood TB: Country Introduction of Improved FDCs
Cherise Scott, Director of Pediatric Programs at TB Alliance, provided an update on the significant progress made in the introduction of improved pediatric fixed-dose combination (FDC) treatment in 2016 (see video). As of October 2016, almost 30 countries had ordered more than 230,000 courses of the product, enough to meet the treatment needs of more than half of the children reported annually with TB, according to the latest World Health Organization data. More countries continue to plan for introduction, and other specially-formulated products for children are in development, including ethambutol (100mg), isoniazid (100mg) and pyrazinamide (150 mg). TB Alliance is working with a wide coalition of partners on the “Louder Than TB” campaign to raise awareness and advocate for adoption of the new medicines. Also, through the use of childhood TB educational materials, TB Alliance’s community engagement program is collaborating with communities and schools to raise awareness among children and families.
Dr. Immaculate Kathure, the Child TB Coordinator of Kenya’s National Tuberculosis, Leprosy and Lung Disease Program (NTLD), discussed her team’s experience rolling out the new childhood FDC and scaling up treatment for children with TB in her country. Explaining the severe challenges of diagnosing and treating childhood cases of TB with currently available tools, she said she is excited to save more children’s lives in Kenya through adoption of a simpler TB treatment. Planning for the introduction and roll-out began in 2015 and involved multiple stakeholders in the country to ensure a smooth transition to the improved products. Kenya’s experience offers insight for other countries seeking to introduce this medication in the coming months.
Sarah Mulera, SHA Community Representative and CE Coordinator at Kenya Medical Research Institute, shared her personal experience with TB in her community of Kibera. After caring for the children of a friend who had died of TB, Sarah became a volunteer community health worker, learning more about TB and sharing her knowledge with her fellow community members at risk for the disease. Sarah has continued to get more involved and is now on the front lines in the fight against this disease, engaging her community to lead to intensified case finding, better understanding and awareness of clinical trials, and also as a key steward in the rollout of the improved childhood medicines.
View the slides from the presentation on Childhood TB
Please direct any inquiries about the event to SHA@tballiance.org
The next Stakeholders Association Meeting will take place in Guadalajara, Mexico in October 2017, in conjunction with the 48th Union World Conference on Lung Health. Additional information will be made available closer to the event.