Fixed-Dose Combinations for HIV/AIDS, Tuberculosis, and Malaria - Report of a Meeting Held 16-18 December 2003 Geneva
(2003; 199 pages) View the PDF document
Table of Contents
Open this folder and view contentsSummary: Observations and some ways forward
Open this folder and view contentsWelcome
Close this folderFixed-dose combinations for tuberculosis: lessons learned from a clinical, formulation and regulatory perspective
View the documentAbstract
View the documentTuberculosis in the world of today
View the documentCombination therapy and fixed-dose combination (FDC) formulations in the management of TB
View the documentRegistration requirements for rifampicin-containing FDC formulations
View the documentConclusions
View the documentAcknowledgments
View the documentAnnex: Bioavailability of rifampicin, the Biopharmaceutic Classification System and the 4D approach to disease management
View the documentResults/c results/comments
View the documentReferences
Open this folder and view contentsProduct costs of fixed-dose combination tablets in comparison with separate dispensing and or co-blistering of antituberculosis drugs
Open this folder and view contentsFixed-dose combinations: artemisinin-based combination therapies for malaria treatment
Open this folder and view contentsDeveloping combinations of drugs for malaria examination of critical issues and lessons learnt
Open this folder and view contentsSafety and long-term effectiveness of generic fixed-dose formulations of nevirapine-based HAART amongst antiretroviral-naïve HIV-infected patients in India
Open this folder and view contentsEffect of introduction of fixed-dose combinations on the drug supply chain: experiences from the field
Open this folder and view contentsEffect of fixed-dose combination (FDC) medications on adherence and treatment outcomes
Open this folder and view contentsEffect of fixed-dose combination (FDC) drugs on development of clinical antimicrobial resistance: a review paper
Open this folder and view contentsFixed-dose combination (FDC) drugs availability and use as a global public health necessity: intellectual property and other legal issues
Open this folder and view contentsPharmaceutical development and quality assurance of FDCs
View the documentAnnotated agenda
View the documentList of participants
 

Abstract

Worldwide, tuberculosis (TB) remains one of the most important communicable diseases in terms of morbidity and mortality. Its control requires multi-drug therapy for at least six months and this tends to lead to patient non-compliance, and thus failure of therapy and ultimately emergence of drug resistance. Anti-TB therapy, given in the form of fixed-dose combinations (FDCs) reduces the number of tablets to be consumed and thereby increases patient compliance with recommended treatment regimens. Thus, FDCs play a significant role in preventing the emergence of drug resistance. However, the quality of FDCs and their registration requirements are major hurdles to their implementation in national programmes. There is also concern about the bioavailability of rifampicin.

To increase use of FDCs, their quality and registration needs to be addressed systematically. It is anticipated that a large global market for FDCs will encourage large-scale production and increased competition, which in turn will result in FDCs at affordable prices. The ‘Global TB Drug Facility’, established by WHO and its Stop TB partners, aims to ensure universal uninterrupted access to quality TB drugs for implementation of directly observed treatment short-course (DOTS) in resource-poor countries. In this programme, four-drug FDCs were accepted as the drugs of first choice because of their obvious advantages in controlling TB.

Current knowledge on anti-TB FDCs, their dosage, combinations, available clinical studies and the experiences with TB therapy should serve as lessons for selection of appropriate FDCs for other diseases such as malaria and AIDS.

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Last updated: May 3, 2013