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1/8/2004

WHO, UNAIDS Set HIV Treatment Goal for Developing Countries

Kate Traynor

The World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) in December unveiled the Treat 3 Million by 2005 Initiative—better known as 3 by 5—an ambitious plan to bring effective antiretroviral therapy to 3 million HIV-infected people in developing countries by 2005.

"Whether we get there by 2005, that will depend on what we do today," emphasized UNAIDS Executive Director Peter Piot, during a December 1 webcast sponsored by the Kaiser Family Foundation.

A WHO strategy document describes 3 by 5 as a "comprehensive strategy linking treatment, prevention, care and full social support for people affected by HIV/AIDS." The success of the initiative will require cooperation among national and local governments, employers, private foundations, faith-based organizations, and communities, according to WHO.

"I think that this is achievable," said Chiedza Maponga, chair of the Department of Pharmacy at the University of Zimbabwe, in an e-mail interview. "However, there needs to be a strong global commitment, particularly from the rich countries."

The AIDS crisis in Africa, Maponga said, "is like a house that's burning. The next-door neighbors have an interest in extinguishing the fire before it spreads. AIDS knows no boundaries. We should deal with this epidemic as our social responsibility and also see it as a global public health threat."

Maponga travels between Zimbabwe and his alma mater, the School of Pharmacy and Pharmaceutical Sciences at the State University of New York, University at Buffalo, where he is a visiting professor in the department of pharmacy practice. His contributions to fighting AIDS in Zimbabwe include securing funding from the U.S. Centers for Disease Control and Prevention for community HIV and AIDS services and treatment, working with international agencies to bring antiviral treatment to HIV-infected people, and helping persuade the government to declare AIDS a national emergency, thereby opening the door to the entry of generic antiretroviral drugs from outside Zimbabwe.

Maponga will be involved in implementing 3 by 5 in Zimbabwe, where, according to WHO, 25% of the country's 7.6 million adults are infected with HIV. The average life expectancy in the country is 39 years, largely because of AIDS.

Committing to the fight. Maponga said that political commitment by African nations is "the biggest challenge" to implementing 3 by 5 in that part of the world. But, he said, the situation is improving.

"Recently," Maponga said, governments in southern Africa "have acknowledged HIV/AIDS as a threat, and they are slowly coming up" to deal with the epidemic.

WHO's strategy document on 3 by 5 likewise describes an increase in the political will to deal with the disease. This factor, coupled with a decrease in the cost of antiretroviral therapy (see box), has produced an opportunity that, WHO stated, "must now be seized with urgent action."

Agreement Brings Price Relief

A decision by World Trade Organization (WTO) member countries last August paves the way for underdeveloped nations to obtain antiretroviral drugs that were previously priced beyond the means of poor countries.

WTO's Trade-Related Aspects of Intellectual Property (TRIPS) Council agreed August 30, 2003, to allow countries with no manufacturing capabilities to contract with foreign drug makers to produce generic copies of patented medications to address a specific, declared public health crisis, such as AIDS, tuberculosis, or malaria. Before the TRIPS agreement, the emergency production of such medications could take place only in the country that was to use the drugs—an impossibility in nations with no manufacturing sector.

The 30 WTO member countries designated as "least-developed" are assumed by the trade organization to have no manufacturing capacity. Countries not on this list can also have copies of patented medications made outside of their borders as long as WTO agrees that the applicant country is unable to produce the needed drugs.

Of note, Aspen Pharmacare of South Africa launched a generic version of stavudine last summer to become the continent's first producer of generic antiretretroviral drugs. The company claims to be awaiting regulatory approval to produce six other antiretrovirals, all in compliance with WTO rules.

Four drug regimens. To support the rollout of 3 by 5, WHO updated its antiretroviral therapy guidelines last month to recommend four first-line treatment regimens for adults and adolescents infected with HIV. The regimens consist of a thymidine analogue nucleoside reverse-transcriptase inhibitor—either stavudine or zidovudine—in combination with lamivudine and a nonnucleoside reverse-transcriptase inhibitor, either nevirapine or efavirenz.

These drugs were chosen for reasons including the availability of fixed-dose combinations, the stability of the products at room temperature, and the availability and cost of the drugs. Factors that influence a clinician's choice of a specific regimen include the patient's tuberculosis status, the need for laboratory monitoring, and whether the patient is or may become pregnant.

WHO also provides guidelines for switching medications because of pregnancy or adverse events, such as stavudine-related neuropathy or pancreatitis or efavirenz-related central nervous system toxicity. Also addressed is the use of second-line regimens when the initial therapy fails to control the infection.

Resistance monitoring. The widespread use of antiretroviral drugs could bring another problem to the developing world—the spread of resistant forms of HIV. To address this issue, the WHO Global Resistance Network has created a draft guidance document calling for surveillance focused "on individuals newly diagnosed with HIV in most countries where treatment access is being expanded."

Through surveillance, WHO plans to track trends in resistance, targeting groups such as pregnant women and adolescents who come to clinics for voluntary HIV testing. WHO notes that the routine resistance testing of recently infected people is impractical in the developing world.

Some of the concerns about viral resistance have their roots in poverty.

"There is a danger," Piot said, "in poor families, in poor countries, that one person—let's say the husband is, or the wife is treated, and they share the capsules . . . so that only half the dose is taken."

"That's why it is so important to have strong community engagement. . . . It's not just parachuting the drugs" into the country with no guidance for patients, he said.

Maponga noted that poverty adds a further complication to therapy, in addition to resistance and the usual adverse events associated with antiretroviral treatment.

When modern health care is not available, he said, "people have to resort to traditional herbal medicines."

"These medicines can bring new challenges, as we have to study how they interact with anti-AIDS drugs," he said.

Procurement. WHO states that the ability of underdeveloped nations to tap a readily available, sustainable source of antiretroviral medications is "a key component" of the 3 by 5 program. Through the creation of the AIDS Medicines and Diagnostics Service (AMDS), WHO plans to set up global and regional networks of buyers and serve as a source of demand forecasting and information on current costs and sources of antiretroviral drugs.

Billed as the "access and supply arm of the UNAIDS/WHO 3 by 5 initiative," AMDS will not directly purchase medicines, according to WHO, but will act as a facilitator for all parties involved in the drug procurement process.

An important role for AMDS is to "prequalify" drug products that meet WHO's safety and efficacy standards. The prequalification list currently contains 48 single-drug antiretrovirals, five two-drug antiretroviral combination products, and one triple-drug combination. WHO has also prequalified 24 HIV diagnostic kits.