Search Results for: Bedaquiline
in Challenge TB, TB CARE I, TB CAP and partner tools.
in Challenge TB, TB CARE I, TB CAP and partner tools.
With more than 480,000 cases of multi-drug resistant TB every year and the conventional treatment being long, toxic, expensive, and having very low levels of treatment success, the need for new drugs and regimens is beyond question.
USAID’s Challenge TB project is driving the introduction of new drugs and regimens for the treatment of drug-resistant TB. These new regimens are bringing hope to thousands, some of whom were all out of other options.
With Challenge TB support, all our countries have developed a policy framework, trained staff, expanded diagnostic capacity, and ensured that drugs and budgets have put in place for nationwide access for all eligible patients. In addition, Challenge TB has supported the development and implementation of active pharmacovigilance systems and procedures to manage adverse events (aDSM), both of which are necessary for the safe use of the new and repurposed medicines.
Individualized regimens containing Bedaquiline are now available in all Challenge TB supported countries, Delamanid is in 14 countries, and the shorter regimen is in 20 countries with the final 2 due to start shortly.
The aim of this implementation plan is to assist countries (particularly high MDR-TB burden countries) in the preparation and conduct of necessary activities for the introduction of bedaquiline to ensure that patients in need get access to bedaquiline and are treated in a way that maximizes the benefits for patients and the programme. It provides a logical and comprehensive framework, adaptable to a large diversity of country and programme settings.
With recent developments in drug-resistant TB (DR-TB) treatment, particularly the approval for use of the new drugs, bedaquiline and delamanid ahead of the completion of Phase III trials, there is a need for early and systematic detection, management, recording, and reporting of any adverse events that may occur in patients who are prescribed these medications.
To meet this need we have published a new guide on Active drug safety monitoring and management (aDSM).
This technical guidance document introduces the concept of aDSM for new drugs and regimens used in the treatment of drug-resistant TB patients, outlines the definitions related to aDSM, the agreed essential activities, and the key steps in implementing aDSM in patients on treatment.
The “Quality Improvement Tool” (QI Tool) was developed under the “Core Bedaquiline Coordination Project” for Challenge TB. The checklist (available in English, Russian and Ukrainian) was adapted from earlier tools developed by the European Respiratory Society (ERS), European Centre for Disease Control (ECDC), and Challenge TB Indonesia on the clinical management of TB patients, and upgraded for use by a new target group, namely: supervisors and monitoring specialists working at the NTPs and partner organizations. The tool was pilot-tested in countries in Central Asia Region, Eastern Europe, South East Asia and Africa, at the district and facility levels. Electronic versions of the checklist will be available in the near future. The Authors acknowledge the contributions of the ERS and the ECDC in designing this tool (as part of the ESTC document development and European audit).
This is a job aid for nurses and also visual information for patients. As the use of Bedaquiline (Bdq) is completely new, and there are changes in administration of the drug during the treatment course, this visual material will help healthcare workers to learn the changes and ensure patients receive the right dosage. The dosage charts are available in English, Ukrainian and Russian.