A breakthrough pricing agreement for HIV drugs means the first affordable, single-pill antiretroviral treatment is likely to be made available in 90 low- and middle-income (LMIC) countries.
The generic, single-pill HIV treatment regime, which contains dolutegravir (DTG), could become widely available in LMIC countries for around US $75 per person, per year – about a tenth of the current price.
The deal is the result of coordinated efforts between pharmaceutical manufacturers, United Nations agencies, NGOs, and national governments. It is expected to significantly increase treatment coverage, as countries will be able to start many more people on treatment without increasing budgets. Under the agreement, generic DTG can be sublicensed in 92 countries at a price ceiling that applies to both low- and middle-income countries.
Kenya began using generic DTG earlier this year, and South Africa is due to make the treatment widespread in April 2018, with estimated savings of US $900 million over the next six years.
UNAIDS Executive Director Michel Sidibé said: ‘This agreement will improve the quality of life for millions of people living with HIV. To achieve the 90-90-90 treatment targets, newer, affordable and effective treatment options must be made available—from Baltimore to Bamako—without any delay.’
DTG offers faster viral load suppression, fewer side effects and better defense against drug resistance, but until now has been too expensive for LMICs. It is widely used in high-income countries and is recommended by the World Health Organization as an alternative first-line HIV regimen.
As the effectiveness of DTG is likely to result in more people remaining within the HIV treatment cascade, its widespread use is also expected to reduce the need for more expensive second- and third-line regimens, which people are moved onto should their initial treatment regimen fail.
Following announcement of the agreement, concerns were raised that plans to cut the budget of the Presidential Emergency Plan on AIDS Relief (PEPFAR) by 17%, from US $4.6 billion to US $3.8 billion, could jeopardise the generic drug’s rollout in some countries.
Talking to UK newspaper The Independent, Dr Larkin Callaghan, Director of Strategic Communications and Partnerships at the Aids Research Institute at the University of California, San Francisco, said the DTG pricing deal “should underscore the need for PEPFAR to remain fully funded.”
In addition, the Medicines Control Council has said that only two pharmaceutical companies have applied to register generic DTG so far. This means there will be limited competition when companies tender to supply the drug next April, as there is not enough time for rival manufacturers to get their products approved by then.
Treatment Action Campaign spokeswoman Lotti Rutter said more generic manufacturers needed to enter the market to ensure the new regimen reached the lowest possible price.