Issues on HIV Pharmacotherapy in Developing Countries

International Perspectives
ALTERNATIVE DEVELOPMENT: A GLOBAL THEMATIC EVALUATION Final Synthesis Report Issues on HIV Pharmacotherapy in Developing Countries ICHAPRT Chitungwiza (UTANO) Community Partnership Project Other Links

Charles Chiedza Maponga, Pharm.D., MHPE

Research Associate - ICHAPRT Director
Department of Pharmacy Practice
University at Buffalo
University of Zimbabwe
Email: cmaponga@buffalo.edu

Access to HIV Pharmacotherapy

The past two decades have seen worldwide therapeutic advances in research on the Human Immunodeficiency Virus (HIV) and management of the Acquired Immunodeficiency Syndrome (AIDS). Disparities however exist in the extent of those advances between the developed and the developing world. In wealthy nations antiretroviral drugs are now routinely used to significantly reduce morbidity and mortality associated with HIV/AIDS while poor nations can hardly access the drugs mainly due to their high cost. This is in spite of the fact that the developing countries contribute over 90% of the HIV burden.

The devastation caused by the HIV epidemic in the developing nations is due to limited fiscal resources, scarce educational opportunities, and inadequate infrastructure. These together with other epidemiological, social, cultural, economic, political, and technological issues affect HIV Pharmacotherapy implementation in developing countries. In order to address these disparities, international collaboration is increasingly being considered as a way of achieving equitable access to HIV Pharmacotherapy.

The Buffalo HIV Pharmacotherapy Network's International Center for HIV/AIDS Pharmacotherapy Research and Training (ICHAPRT) is engaged in research and training aimed at promoting rational distribution and use of HIV/AIDS and other essential drugs in resource limited settings. Major areas that are covered include pharmacoeconomics, pharmacogenomics, pharmacoinformatics and pharmacoepidemiology.

ICHAPRT explores a comprehensive system of mutually supportive strategies that have been shown to address the problem of equitable access to drugs such as:

• Actively encouraging generic competition
• Seeking differential pricing of drugs from international suppliers
• Adopting World Trade Organization - Trade Related Intellectual Property Rights safeguards into national legislation (making sure that all legislation is in place)
• Creating high volume/high demand through global procurement
• Encouraging local drug production through licensing and technology transfer
• Evaluating the total cost of HIV management including drugs and exploring the issue of financing considering the potential levels of contribution from users fees, donors, government, and medical aid societies.

Quality and Bio-equivalence Surveillance

HIV/AIDS is currently a major killer disease in sub-Saharan African and other parts of the developing world. Effective management of this public health epidemic requires, among other measures, the use of effective and good quality drugs. HIV/AIDS drugs are not yet used widely in public health programs in the region. However, in most of the countries there is significant utilization of these drugs within the private sector. Because of their high costs, there is a great potential for substandard or counterfeit products to appear on the market.

The World Health Organization's Essential Drugs and Medicines Policy Department has already recognized the need for provision of good quality antiretroviral drugs by taking steps to implement an HIV/AIDS Drugs Pre-qualification program. That program is aimed at ensuring that medicines procured by United Nation Agencies are only from inspected and certified suppliers. That initiative is a positive step. However, it does not fully address the problem of counterfeit drugs that normally originate from unknown sources.

In developing countries, the need for routine monitoring of drug concentrations is overshadowed by the need to decrease the cost of therapy. However, serum drug concentration assaying may be justified for several reasons. First, in order to access antiretrovirals in Africa the use of more affordable generic products is being encouraged. This creates the need to test and ensure that the generic products are bio-equivalent to the innovator ones. Second, it is recognized that even if extensive studies are being carried out in the developed countries, there might be population and racially related differences that warrant additional pharmacokinetic or pharmacogenomic studies in developing countries. Third, drug concentration determination may be needed to determine patient adherence to therapy regimens in cases of therapeutic failure, as an alternative to the currently unavailable viral load, lymphocyte counts and resistance testing in the resource limited environment. The drug levels might also need to be determined in order to differentiate concentration depended versus non-concentration dependent drug toxicities. Fourth the environmental conditions such as temperature, humidity, and light that are known to affect the stability of pharmaceuticals may affect products either during transportation or storage leading to instability resulting in possible decreased efficacy of the products.

Therefore, with the scarcity of laboratory support in developing countries, there may be need for drug concentration determination and pharmacokinetic interpretations within clinical settings for the purpose of differentiating pharmacological from pharmaceutical failures. International research and training that responses to the need for quality and bio-equivalence surveillance systems in developing countries is currently being addresses under the Buffalo HIV Pharmacotherapy Network's ICHAPRT.

Therapeutic Precision Assurance

The complexity of the relationship between virology, pharmacology, and patient related factors create a significant challenge in HIV pharmacotherapy. Success of antiretroviral therapy is strongly depended not only on access to good quality pharmacological agents but also whether the patient is capable of receiving them in a rational and accurate manner.

The science that deals with maximizing therapeutic efficacy while limiting the chance of experiencing toxicities is collectively termed therapeutic precision assurance. The Buffalo HIV Pharmacotherapy Network has developed a number of these interventions and is in the process of developing mechanisms to disseminate some of them internationally. Some of the already developed and functional programs within the Network include:

• Patient adherence to therapy
• Resistance monitoring
• Adverse Drug Reaction monitoring
• Drug interaction (drug-drug, drug-food) alert
• Therapeutic drug monitoring (drug concentration assays)