More than 8 million people in developing countries were receiving antiretroviral therapy (ART) by the end of 2012, according to UNAIDS. This represents important progress. But a further nearly 7 million people are in urgent need of treatment and will die without it within the next few years. Scaling up treatment to reach all people in need is critical. Just as important is ensuring that those who already receive treatment are able to maintain access to a regular flow of newer medicines they will need to survive in the long run, as drug resistance inevitably develops over time. And with 34 million people living with HIV globally, the need for access to affordable and adapted HIV medicines is increasing.
Earlier, improved treatment recommended by WHO
People living with HIV in developing countries need access to medicines sooner, and they need access to newer formulations better adapted to their needs.
The World Health Organization (WHO) in 2010 published new treatment guidelines for HIV/AIDS. These state that people in developing countries should receive antiretroviral medicines (ARVs) earlier in their disease progression – as do their counterparts in wealthy countries – instead of waiting until the virus has already made them much more susceptible to ‘opportunistic infections’ such as tuberculosis, the number one killer of people living with HIV/AIDS. This means that (compared to previous recommendations) the number of people considered to be in urgent need of receiving treatment has risen from roughly nine to 15 million, of whom only 8 million currently receive it. This leaves a treatment gap, which is especially critical in light of new science indicating treatment not only save lives but can also stop further spread of HIV.
Further, WHO recommends phasing out the drug stavudine (d4T) – which is part of the most-commonly-used HIV medicine combination in developing countries, but which causes considerable side effects. WHO states it should be replaced by either zidovudine (AZT) or preferably tenofovir (TDF), which are both safer options. However, despite prices having come down considerably for newer medicines over the last several years (the most affordable stavudine-containing regimen costs under $70 per patient per year), this switch still comes with a considerable price tag: according to Médecins Sans Frontières, the most affordable generic one-pill-once-a-day TDF-containing regimen costs $176 per patient per year, and in many middle-income countries, where patents prevent the sale of more affordable generics, this combination can cost six times more, at $1,033 per patient per year.
Newer treatments priced out of reach
People living with HIV need access to newer treatment options – second-line or third-line ARV regimens – for when drug resistance inevitably occurs and medicines stop working for them. When people become resistant to their HIV medicines, they become ill again, and are at risk of succumbing to opportunistic infections such as tuberculosis. However, most of the newest HIV medicines are likely to be patented in key generics producing countries such as India and Brazil, which means that affordable versions that were available with the first generation of HIV medicines will not be for the newer generations of drugs.
And in the absence of competition among multiple producers, prices are likely to remain high: the most affordable second-line combination costs US$465 per patient per year, more than three times as much as the recommended first-line combination. And for patients who show signs of treatment failure on a second-line regimen, the price increase can be more than 23 times, at up to US$3,204 per patient per year, according to Médecins Sans Frontières. These prices are not sustainable for treatment programmes in the majority of countries affected by the AIDS epidemic.
Children with HIV/AIDS left behind
Children living with HIV live almost exclusively in developing countries, where few market incentives exist for larger companies to develop and produce the adapted formulations required to treat them. As a result, paediatric HIV has become a neglected disease.
Successful strategies to prevent transmission of HIV from mother to child at birth (PMTCT) mean that almost no babies are born infected with HIV in wealthy countries any longer. In developing countries, in contrast, nearly half a million children were newly infected this way in 2008.
Because the market for paediatric HIV/AIDS essentially only exists in developing countries with limited ability to pay high prices, there is very little pharmaceutical research and development for HIV medicines for children. Of the 22 ARVs approved for adults by the US Food and Drug Administration (FDA), six do not come in any paediatric formulation, of which five in turn are not even approved for use in children. Further, when formulations for children do exist, they are often difficult to administer, such as syrups that have to be taken in large amounts and can have a foul taste. While several fixed-dose combination drugs finally do exist for children, many more treatment options are needed, including FDCs that contain newer, safer and/or and second-line medicines.
Treatment needed to prevent new HIV infections
New science has revealed that timely treatment can not only save lives but also prevent new HIV infections, magnifying the need for appropriate, affordable medicines in large quantities — and as soon as possible.
A clinical trial funded by the US National Institutes of Health announced in May 2011 its findings that earlier treatment reduced HIV transmission rates by 96 per cent. This means that the tools to stem the rising tide of the HIV epidemic are within reach – if the world can organise to get medicines in the hands of people who most need them.