The World Health Organization (WHO) has evaluated several HIV-related medicines and today publishes the first list of products from suppliers which were found to meet WHO recommended standards. This is a key part of an inter-agency project supported by UNAIDS, UNICEF, the UN Population Fund and the World Bank, for wider access to diagnosis and treatments for HIV and opportunistic infections.
The idea is that international research-based companies and alternative international "generic" suppliers can be assessed to the same standards, to guide governments and international agencies in procuring quality products at competitive prices.
By creating a process equally open to multinational companies and smaller generic companies, this Access to Quality HIV/AIDS Drugs and Diagnostics project aims to achieve a sustainable reduction in prices for countries that cannot afford to provide large-scale treatment access at European and North American prices.
The initial list of forty products from eight "branded and generic manufacturers" includes eleven anti-retrovirals (ARVs) and five products for opportunistic infections.
The ARVs on the list allow for several triple (or quadruple) therapy combinations. However, they do not yet include all of the drugs licensed in North America and the European Union - for example, efavirenz and indinavir are missing. In some cases, only one formulation is included - for example, soft-gel saquinavir but not the older hard-gel saquinavir, which can be used with ritonavir and which some patients positively prefer in that combination due to better tolerability. Similarly, the enteric coated formulation of didanosine is not included, despite its advantages for quality of life over the buffered tablets which are included.
Three antiretrovirals manufactured by the the Indian company Cipla have been included in the list. AZT (zidovudine), 3TC (lamivudine) and nevirapine are included, but a number of other agents manufactured by Cipla and other Indian companies such as Aurobindo, Hetero and Ranbaxy do not appear. However, the assessment process is ongoing, and it is likely that other agents will join the list. One difficulty inherent in the process is that Cipla and a number of other companies have produced co-formulations of three antiretroviral drugs which have no equivalent in Europe and North America.
The list includes one antiretroviral drug - zalcitabine (ddC), from Roche - which is little used in most countries, as it is linked to severe neuropathy.
The list also includes a generic version of aciclovir cream, produced by Cipla Ltd in India, although WHO's own Guidelines for the management of sexually transmitted infections, issued in 2001, say that "topical therapy [of herpes] with aciclovir produces only minimal shortening of the duration of symptomatic episodes and is not recommended."
The Access to Quality HIV/AIDS Drugs and Diagnostics project is part of a UN-wide strategy to improve access to HIV treatment. The strategy is meant to promote rational use of drugs; affordable prices for medicines and diagnostics; sustainable financing; and reliable health and supply systems. Another 13 suppliers and 100 products are currently under review.
Through its department of Blood Safety and Clinical Technology, WHO is also evaluating HIV test kits and technologies to monitor HIV drug treatment.
In addition, guidelines on minimum requirements for laboratory monitoring of HIV drug treatment are being developed. WHO is also developing training and quality assessment programmes for health care workers to ensure correct use of diagnostic tests.
The full news release and first list are available on the WHO web site.