In the best-case scenario‚ by 2019 two new drug combinations could treat an additional 2-million people without an increase in cost.
“If successful‚ patients will benefit with a much safer and more forgiving regimen in a smaller tablet‚ government and other funds will save money‚ while pharmaceutical producers will have simplified manufacturing‚ using lower volumes of active… ingredients.
“The clinical studies and registration processes to secure inclusion of these two new drugs‚ if successful‚ would be a huge South African victory.” Francois Venter‚ of the Wits Reproductive Health and HIV Institute‚ said that by mid-2016 South Africa had 3.4-million people on the world’s largest HIV treatment programme‚ collectively using a quarter of all generic antiretrovirals available worldwide.
“An increase in public spending is expected to continue‚ owing in part to recent changes in antiretroviral therapy (ART) initiation guidelines‚” he said.
“The Department of Health announced its endorsement to ‘treat all’ approaches from September 2016… theoretically doubling the number eligible for ART.” With 600,000 people a year expected to need medication and HIV-positive patients surviving for longer thanks to the treatment‚ annual costs of R4.9-billion were set to reach R6.3-billion by 2019.
However‚ two cheaper drugs were being licensed to manufacturers of generic medication. One‚ dolutegravir‚ had fewer side-effects and higher virological resistance; the other‚ tenofovir alafenamide‚ was less harmful to bones and kidneys. Combining the new drugs with other medicines “would also substantially reduce the size of the current tablet‚ making it easier to manufacture‚ while saving on packaging and storage space”.
The aim of the Advance study‚ said Venter‚ was to provide the evidence needed to change treatment guidelines. “Results may be available by the end of 2018 for Medicines Control Council registration and Department of Health guidelines and tender processes‚ so that the new regimen can be rolled out from 2019.”
The study‚ funded by the US Agency for International Development and the global health initiative Unitaid‚ has been designed by a multidisciplinary group of researchers‚ doctors‚ activists‚ donors and public health specialists. It has backing from the Department of Health and the World Health Organisation.
“The introduction in South Africa of this new regimen has the potential to substantially reduce the cost of first-line ART‚ while also being safer and better tolerated‚ therefore limiting the need for second-line ART‚” say the experts. “We estimate potential cost-savings for South Africa if the studies demonstrate efficacy and safety‚ and justify the urgency in completing the study swiftly and transitioning to the new combination without delay.”