Could the new WHO initiative put too much strain on ARV production in SA? UCLA and Aspen speak

Under its latest initiative, the World Health Organisation (WHO) reportedly plans to test the entire population for the virus, treating each individual immediately after infection before they develop symptoms. 

Although more than five million are infected in the country, ordinarily treatment in South Africa is not given until the patient has a CD4 (cluster of differentiation 4) cell count – the glycoprotein that protects the surface of immune cells which the virus attacks – below 350.

But in a journal article published in PloS ONE, senior author and director of the UCLA (University of California, Los Angeles) Center for Biomedical Modeling Sally Blower said the strategy is faulty, because the healthcare infrastructure is not enough to keep up with the added pressures on drug production and testing.

"Before implementing a 'test and treat' strategy, we recommend trying to provide treatment for all those in need as quickly as possible," ​Bradley Wagner, who also worked on the study, added. "This is desperately needed in South Africa."​

However, speaking to in-PharmaTechnologist.com, senior executive for strategic trade development at Aspen Pharmacare – one of the firms currently on a tender to provide ARVs (antiretrovirals) to the South African Government – Stavros Nicolaou said there is now enough manufacturing infrastructure to deal with the demands.

He said previous supply chain issues​ would not come into play, adding that the flaw in the plan lies with funding: “The problem is not the manufacturing capabilities here, the problem is who will fund it. From the point of view of manufacturing drugs, the capabilities exist in the country. ​

"There’s about ten companies currently on the tender including Sipla, Medpro, Aspen, Abbott, and Aurobindo, and there are other companies in the country not on the tender I’m sure the Government could look to.”​

He said however that funding is already tight because of a Government programme to increase the number of people on treatment from around 1.6m per year now to 2.5m by January.

“If you’re going to increase that again I don’t know where the money would come from. About 90 per cent of public sector funding comes from the public health care spend, and only 10 per cent comes from donor funding,”​ Nicolaou added, before saying unless there was a huge windfall from somewhere soon, he believes the program is unrealistic.

If it ain’t broke…​

The WHO based its latest initiative on a mathematical model that predicts treating the entire patient population of South Africa – regardless of whether they are showing symptoms or not – will eradicate the disease in the country within a decade.

However in the UCLA study – which uses a different mathematical model – Blower et al say that the model is incorrect because it “​is unrealistic, and if you use an unrealistic model, you get the wrong answer."​ The team added that treating the disease on such a wide scale could lead to several million cases of drug-resistant strains.

Instead, the researchers said the current method in which only those with symptoms are treated is a better course of action, adding that it could still help wipe out the disease.

"Our model shows that providing treatment to the 1.6 million people who are in need of treatment would be very effective as a form of treatment as prevention"​ said Wagner.  

"It could bring the HIV epidemic in South Africa close to elimination and prevent 11 million infections over the next 40 years. Our model also shows the WHO's 'test and treat' strategy would actually cost $12 billion more than providing treatment to the 1.6 million in need."​