In 2018, a quality-assured, 125mg capsule of cycloserine became available to countries and programs treating children with rifampicin-resistant forms of tuberculosis. This capsule is an additional formulation to the standard adult capsule which is 250mg. Although not technically a “pediatric formulation”—since the capsule is not dispersible—the existence of this 125mg capsule should allow for more precise dosing and less drug wastage in young children, since the World Health Organization recommends a weight-based dose of 15-20mg/kg/day. For a number of reasons, however, there have been challenges with the availability of the 125mg cycloserine capsule, and countries may find they are either unable to obtain the smaller capsule or are unable to use the capsule in their countries. If the 125mg capsule is not available, it is recommended that the larger 250mg capsule be used. A practical approach to using the larger capsule is detailed in the attachment, along with more information on weight-based dosing for other TB drugs.
On behalf of the HMS Center for Global Health Delivery, the Sentinel Project on Pediatric Drug-Resistant Tuberculosis and el Centro de Salud Global at Socios en Salud, we would like to thank everyone who was able to join our virtual symposium “Advancing Tuberculosis Preventive Therapy as an Emergency Response to COVID-19” on January 27, 2021.
If you were unable to attend, or you would like to revisit a topic from the symposium, full-length recordings are available on the HMS Center for Global Health Delivery website. You can follow the link below to access the recordings and review the presentations and bios of each of the speakers.
We hope this symposium emphasized the need to increase access to preventive therapy as we continue to juggle the dual burden of tuberculosis and COVID-19 and we look forward to seeing you all at more events in the future!
En nombre del Centro de Salud de HMS, el Proyecto Sentinel sobre Tuberculosis Pediátrica Resistente a los Medicamentos y el Centro de Salud Global de Socios en Salud, queremos agradecer a todos los que pudieron unirse a nuestro simposio virtual “Avanzar en la Terapia Preventiva de La Tuberculosis como Respuesta de Emergencia al COVID-19” el 27 de enero de 2021.
Si no pudo asistir, o desea revisar un tema del simposio, la grabación del evento está disponibles en el sitio web del Centro de Salud Global de HMS. Puede seguir el siguiente enlace para acceder a las grabaciones y revisar las presentaciones y biografías de cada uno de los ponentes.
Esperamos que este simposio haya llamado atención a la necesidad de aumentar el acceso a la terapia preventiva a medida que continuamos haciendo malabares con la doble carga de la tuberculosis y el COVID-19, ¡y esperamos verlos a todos en más eventos en el futuro!
The Sentinel Project resource “Get the Facts about Drug-Resistant Tuberculosis: A Resource for Families” is now available on our site. It serves as a quick guide on DR-TB and how best to manage and treat it.
Get the Facts about Drug-Resistant Tuberculosis: A Resource for Families
There have been some important changes to the delamanid compassionate use protocol. Delamanid is available for compassionate use and can be obtained from the company at no charge on a patient-by-patient basis.
The company has made some changes to their access and eligibility criteria and these are summarized below. Perhaps most exciting is that the pediatric formulation of delamanid (a 25mg dispersible tablet) will also be available via compassionate use. This formulation is not yet on the market but is an important tool for younger children with RR-TB. We are thrilled the company has now made this formulation available for the children who need it.
Please find additional information below.
Updates to Delamanid Compassionate Use Protocol
- Male and female patients ≥ 3 years of age are eligible for CU DLM enrolment
- Prior delamanid use is no longer an exclusion criterion
DLM treatment duration
- The current protocol 242-302-00014 allows treatment extension of CU DLM on a case by case basis. Re-application for a treatment extension with delamanid can be made in exceptional cases, in order to minimize the probability of a resistance development to anti-TB treatment and/or enhance the likelihood of a favourable treatment outcome in difficult to treat cases.
- IMP of the pediatric formulation (dispersible tablets of 25 mg) is undergoing final packaging and testing and shall become available for patients enrolled in the updated CU protocol 242-302-00014 shortly.
PV reporting timelines
- The updated CU protocol 242-302-00014 requires reporting of all safety information within 24 hours (not just for SAE as in the previous CU protocol 242-12-401 but all AEs + safety information)
The Paediatric Drug-Resistant TB Donation Initiative is led and funded by the Stop TB Partnership’s Global Drug Facility in partnership and with financial support from USAID.
In June 2018, the South African National Department of Health announced that bedaquiline will now be used to replace the injectable agent in routine treatment of rifampin-resistant and multidrug resistant tuberculosis (RR/MDR-TB) in patients over 12 years of age. We congratulate the leadership of the South African National TB program for taking this important step.
We note with some concern that children under the age of 12 years may be precluded from accessing the benefits of an all-oral RR/MDR-TB regimen. As such, we call for policies to support all-oral regimens for patients under 12 years of age in South Africa and globally. In partnership with the Desmond Tutu Tuberculosis Centre (DTTC) and Treatment Action Group (TAG), Sentinel Project has developed the following recommendations for injectable-free regimens for children under the age of 12 years.
Please download these recommendations here: Recommendations for Injectible-Free Regimens in Children with Rifampacin Resistant TB.