Generic and low dose antiretroviral therapy in adults and children: implication for scaling up treatment in resource limited settings

In 2008, an estimated 33.4 million adults and children were living with HIV worldwide [1], most of whom were from low and middle income countries, and 9.6 million people were in need of antiretroviral treatment (ART) [2]. However, 5.5 million people (58%) had no access to treatment. Even though the great majority of HIV infected people live in Sub-Saharan Africa, 4.7 million HIV infected people are living in Asia [1]. The ART coverage in East, South and South-East Asia was only 37% in 2008 [3]. Although this is an increase compared to the 29% in 2007, the scaling up of antiretroviral therapy is still slow. This review will focus on two important ways of achieving ART scale up in resource-limited settings: safe and effective generic ART, and dose reduction of ART.In 2001 the World Health Organization (WHO) initiated the prequalification of priority medicines to make these available to millions of patients in need in resource-limited settings. In 2004, the U.S. Food and Drug Administration (FDA) launched a program to ensure that HIV patients being served by the President's Emergency Plan for AIDS Relief (PEPFAR) would receive safe, effective and quality manufactured ART. This new initiative included an expedited review process, and a strong encouragement for manufacturers worldwide to submit U.S. marketing applications for previously approved antiretroviral therapies, even if there was still a patent or exclusivity market protection for the product in the U.S. Currently, the FDA has given tentative approval to 107 generic antiretroviral drugs [4] which gives generic manufacturers the opportunity to produce safe, effective and good quality antiretroviral therapy combinations without having to face patent claims.The introduction of generic fixed dose combination (FDC) antiretroviral therapy by companies in India and Thailand has significantly increased the access to treatment in many resource limited countries and is a major contributing factor to the unprecedented drop