Fixed-Dose Combinations for HIV/AIDS, Tuberculosis, and Malaria - Report of a Meeting Held 16-18 December 2003 Geneva: Safety and long-term effectiveness of generic fixed-dose formulations of nevirapine-based HAART amongst antiretroviral-naïve HIV-infected patients in India: References

Fixed-Dose Combinations for HIV/AIDS, Tuberculosis, and Malaria - Report of a Meeting Held 16-18 December 2003 Geneva
(2003; 199 pages)

Índice de contenido

	Summary: Observations and some ways forward
		A. Overall observations
		B. Experiences with fixed-dose combinations
		C. Public health priorities
		D. IP and legal options
		E. Pharmaceutical development, quality assurance, and regulatory requirements
	Welcome
		Objectives of the meeting
		Expected outcomes
		Presentations on TB FDC issues
		Presentations and discussions on malaria FDC issues
		Presentations and discussions concerning ARV FDCs
		Presentation and discussion of cross-cutting issues related to logistics, adherence and resistance with FDCs
		Procurement experiences
		Intellectual property and industry issues
		Regulatory issues
		Concluding session
	Fixed-dose combinations for tuberculosis: lessons learned from a clinical, formulation and regulatory perspective
		Abstract
		Tuberculosis in the world of today
		Combination therapy and fixed-dose combination (FDC) formulations in the management of TB
		Registration requirements for rifampicin-containing FDC formulations
		Conclusions
		Acknowledgments
		Annex: Bioavailability of rifampicin, the Biopharmaceutic Classification System and the 4D approach to disease management
		Results/c results/comments
		References
	Product costs of fixed-dose combination tablets in comparison with separate dispensing and or co-blistering of antituberculosis drugs
		Introduction
		Method
		Results
		Discussion
		References
	Fixed-dose combinations: artemisinin-based combination therapies for malaria treatment
		Introduction
		Background
		Implementation issues
		Process leading to the development of guidelines on the use of artemisinin-based combination therapies (ACTs)
		Support to countries in the implementation of ACTs
		Challenges/way forward
		Recommendations for further research
		Conclusion
		References
	Developing combinations of drugs for malaria examination of critical issues and lessons learnt
		Background
		Parasite resistance to antimalarial drugs: a major impediment to effective control
		Strategies to overcome resistance
		Evidence - the key to sensible recommendations
		Further work on the artemisinins
		Recommendations & outstanding challenges
		References
	Safety and long-term effectiveness of generic fixed-dose formulations of nevirapine-based HAART amongst antiretroviral-naïve HIV-infected patients in India
		Abstract
		Introduction
		Methods
		Results
		Discussion
		Immunological improvement
		Viral load
		Clinical findings
		Conclusions
		References
	Effect of introduction of fixed-dose combinations on the drug supply chain: experiences from the field
		Abstract
		Introduction
		Procurement
		Distribution
		Prescribing
		Dispensing to patients
		Cost to patient
		Patient use
		Consumption data
		Conclusion
		References
	Effect of fixed-dose combination (FDC) medications on adherence and treatment outcomes
		Introduction
		Evidence of effect of FDCs or unit-of-use packaging on adherence and treatment outcomes
		Research needs
		Conclusion
		Acknowledgements
		References
	Effect of fixed-dose combination (FDC) drugs on development of clinical antimicrobial resistance: a review paper
		Executive summary
		Introduction
		Biological basis for drug resistance to anti-TB, HIV/AIDS and malaria drugs
		Combination drugs in the context of AMR
		Overcoming clinical resistance using combinations: what is the evidenceⁱ?
		Future research needs
		Conclusion
		Selected studies comparing combinations, FDCs, blister packs and monotherapy with regard to development of antimicrobial resistance
		References
	Fixed-dose combination (FDC) drugs availability and use as a global public health necessity: intellectual property and other legal issues
		Executive summary
		Introduction
		IPRs and Fixed-dose Combinations: Introduction to the “Anticommons Problem”
		IPRs and Fixed-dose Combinations: The “Anticommons Problem” (II)
		Overcoming IP/Legal barriers
		Back to the Future: TRIPS, Public Health, Access to Medicines
		Recommendations
		Conclusions
		References
	Pharmaceutical development and quality assurance of FDCs
		Abstract
		Introduction
		Preformulation studies
		Some examples of the relevance of the properties of the API to product formulation!
		Good Manufacturing Practice (GMP)
		Issues that may arise in the formulation of FDCs that do not arise for single entity products include:
		Changes to registered products (variations)
		Quality control of FDCs
		Recommendations
		References
	Annotated agenda
	List of participants

References

1. Kholoud P. and CASCADE collaboration Survival after introduction of HAART in people with known duration of HIV-1 infection Lancet, 2000; 355:1158-1159.

2. Marins Ricardo J. et al. Dramatic improvement in survival amongst adult Brazilian AIDS patients AIDS, 2003; 17:1675-1682.

3. Montaner JS. et al. A randomized, double blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV infected patients: The INCAS trial. Italy, Netherlands, Canada and Australia study JAMA, 1998; 279:930-937.

4. Podzamczer D. et al. A randomized clinical trial comparing nelfinavir or nevirapine associated to zidovudine/lamivudine in HIV infected naive subjects (the Combine study) Antiviral Therapy, 2002; 7:81-90.

5. Raffi F. et al. The VIRGO study: nevirapine, didanosine and stavudine combination therapy in antiretroviral naive HIV-1 infected adults Antiviral Therapy, 2000; 5:267-272.

6. Leth Van F. et al. for the 2 NN study group,. Results of 2NN study, A randomized comparative trial of first line antiretroviral therapy with regimens containing either nevirapine alone, efavirenz alone or both drugs combined together with stavudine and lamivudine Presented at the Xth Conference on Retroviruses and Opportunistic Infections, Boston, USA. 2003; abstract no. 176.

7. Paterson DL. et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection Annals of Internal Medicine, 2000; 133:21-30.

8. Escobar I. et al. Factors affecting patient adherence to highly active antiretroviral therapy Annals of Pharmacotherapy, 2003;37:775-781.

9. Jintanat A. et al. Swiss HIV Cohort Study. Failures of 1 week on, 1 week off antiretroviral therapies in a randomized trial AIDS, 2003;17:F33-F37.

10. Blomberg B., Fourie B. Fixed-dose combinations for tuberculosis: application in standardized treatment regimes Drugs, 2003; 63:535-553.

11. Newton PN. et al. Murder by fake drugs BMJ, 2002; 324:800-801.

12. Penzak S. et al. Analysis of generic nevirapine products in developing countries JAMA, 2003; 289:2648-2649.

13. Pollard RB., Robinson P., Dransfield K. Safety profile of nevirapine, a non-nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus infection Clinical Therapeutics, 1998; 20:1071-92.

14. Lange J. Efficacy and durability of nevirapine in antiretroviral drug naive patients Journal of AIDS, 2003;34:S40-S52.

15. Kumarasamy N. et al. Natural history of human immunodeficiency virus disease in southern India. Clin Infect Dis, 2003;36:79-85.

16. Pollard R. Factors predictive of durable HIV suppression in randomized double blind trial with nevirapine, zidovudine, and lamivudine in treatment naive patients with advanced AIDS. Presented at 7th Conference on Retroviruses and Opportunistic Infections, San Francisco, USA. 2000; abstract no. 517.