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A mother holds her anti-retroviral drugs
A mother holds her anti-retroviral drugs at a testing and treatment clinic pharmacy in Lagos, Nigeria. Photograph: David Levene for the Guardian
A mother holds her anti-retroviral drugs at a testing and treatment clinic pharmacy in Lagos, Nigeria. Photograph: David Levene for the Guardian

Wanted: a standard model of HIV and Aids diagnostics for Africa

This article is more than 10 years old
A standardised protocol on diagnosis and tests will streamline drug development and distribution, and provide faster treatments

On 13 July, the joint United Nations programme on HIV/Aids (UNAids) announced their ambition to provide anti-retroviral therapy (ART) to 15 million people infected with HIV/Aids by 2015 (up from a total of 9.7 million in 2012). The new framework was published on the back of new WHO guidelines that recommended that patients start treatment earlier.

More specifically, the guidelines raised the threshold of the CD4 count at which ART should be prescribed from 350 cells/mm3 of blood to 500 cells/mm3. CD4 cells are the white blood cells attacked by the HIV virus; their count provides an indication of the state of an individual's immune system and the progression of the disease.

CD4 counts are therefore pivotal to reach the UNAids target, particularly in sub-Saharan Africa where HIV prevalence is high, but the test isn't widely available in countries with poor health care.

In Malawi for instance, only 10% of health facilities offer CD4 counts. The situation is much the same elsewhere on the continent and millions of people are waiting for their CD4 count.

The introduction of decentralised point-of-care tests, which can be used in resource-constrained settings by low-skilled health workers, could significantly increase coverage. In Mozambique, the introduction of point-of-care CD4 counts in primary healthcare clinics doubled the number of patients on ART and halved the time it took for patients to start treatment.

The trouble is that such point-of-care diagnostics are something of a blind spot when it comes to regulation. "We have a very good regulatory framework for drugs but there is a vacuum for diagnostics," says Ilesh Jani, director of the Instituto Nacional de Saúde (National Health Service) in Mozambique. "There is a registration for diagnostics, similar to drugs, but it does not really do a good regulatory function."

Instead, the government will make a decision to introduce a diagnostics on an ad hoc basis, which leaves the sector vulnerable to lobbying and poor quality products, says Jani.

The reason for such regulatory oversight is that point-of-care diagnostics are a relatively recent development, says Brenda Waning, co-ordinator of market dynamics at Unitaid, a global health financing initiative. They were originally developed and approved in the developed world and then brought over to developing countries. "Now there is a lot of innovation in diagnostics designed specifically for use in poorer countries – products that are portable, point of care, and can be used by community health workers," says Waning. "The bad news is that we do not have a global system to ensure the quality of these products."

In a bid to fill that gap, Unitaid decided to grant $5m to the London School of Hygiene and Tropical Medicine to create a harmonised regulatory framework for diagnostics in Africa.

"Nobody can afford to do an evaluation in 50 different countries," says Waning. "If developers can't get their products to market, they will simply move to another space. Yet we know that these point-of-care products will really open a window," she says.

The work of the London School will focus on CD4 counts and two other key diagnostics used in HIV treatments: viral load testing, which tests a patient's response to treatment, and early infant diagnosis (EID), which can test infants before the age of 18 months, when their maternal anti-bodies wear off.

Prof Rosanna Peeling, chair of diagnostics research at the London School of Hygiene and Tropical Medicine, who is facilitating the initiative, said that at the moment, it takes 10-15 years for a product to get to market. Her ambition is to halve that.

She is therefore helping to set up the Pan-African Harmonisation Working Party (PAHWP), a body that will create a harmonised regulatory framework among its members. There are currently eight member states: the East African Community (Kenya, Tanzania, Rwanda, Uganda, Burundi), Ethiopia, Nigeria and South Africa. PAHWP had its first meeting on 24 July and a number of additional countries from west Africa and the Southern Africa Development Community have already expressed their interest to join. Industry representatives have also been invited to take part in the discussions.

Asia has had its own regulatory body, the Asian Harmonisation Working Party, for nearly two decades, so PAHWP is taking stock of its Asian counterpart's experience. Much of the work is about streamlining and standardising processes such as product registration, post-marketing surveillance, quality audits etc, but the crux of negotiations is the issue of clinical trials.

"Because of the lack of regulation, even small countries insist on national data to approve devices," says Peeling. "The first point-of-care test that was marketed for CD4 count had to do 60 trials; it's completely unsustainable," she says.

The PAHWP is working towards is a standard protocol, with fewer trial sites, which will be jointly reviewed by members, even if they haven't fully participated in the trials. It will then be up to individual members to approve the product.

With UNAid's new 2015 target and the first point-of-care viral load and EID tests expected in the next few months, a harmonised regulatory framework won't come a moment too soon. PAWHP will be meeting again in six months, when it should have the first building blocks of its framework in place. Beyond the HIV emergency however, the appeal of PAHWP is that it is building regulatory capacity in Africa that will be applicable to just about any diagnostics. And that alone would be worth supporting.

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