Only two pharmaceutical companies have applied to register three-in-one pills containing the state-of-the-art ingredient dolutegravir, according to the Medicines Control Council.

This means there will be limited competition for the next AIDS drug tender, as there will not be time for rival manufacturers to get their products approved when the pill is introduced in April.

However, the new pricing agreement for low-and middle-income countries announced last week by UNAIDS, means SA is guaranteed to pay no more than $75 per person a year for generic pills combining dolutegravir, tenofovir and lamivudine manufactured by Aurobindo and Mylan — which is about $25 less than the cheapest fixed-dose combination pill on the market.

It took at least 12 months for HIV medicines, which qualify for fast-track assessment, to be assessed by the council, said registrar Joey Gouws. Six companies had applied to register single-dose dolutegravir products, she said.

GlaxoSmithKline has already launched dolutegravir-containing products in SA, but their high cost means they are available only in the private sector.

Tivicay contains dolutegravir alone and costs more than R850 a month, while Trelavue contains dolutegravir, lamivudine and abacavir and costs more than R1,000 a month.

Dolutegravir is to replace efavirenz in the first-line treatment regimen currently used in the state sector.

It had fewer neurological and psychiatric side effects than efavirenz, and patients were less likely to develop drug resistance, said Southern African Clinicians Society president Francesca Conradie. "People’s lives are chaotic, and it is hard to take a pill every day.

"Dolutegravir is much more forgiving of normal life: patients are unlikely to fail (develop resistance) if they forget to take a pill or two."

About 10% of patients on efavirenz-based first-line therapy failed each year and had to switch to more expensive second-line therapy, Conradie said.

"This is a huge step forward for HIV-positive people, healthcare workers and programmes. It’s not often in medicine we get a much better treatment cheaper than the old one," said Francois Venter, deputy executive director of the University of the Witwatersrand Reproductive Health and HIV Institute.

Health Minister Aaron Motsoaledi said SA had played a pivotal role in negotiating the deal, because of the size of its market. There are about 7.1-million people living with HIV in SA, and 3.9-million public sector patients were on treatment by the end of August, more than in any other country in the world.

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. "It is impressive that the entire three-drug regimen will be available for a maximum of $75 per year.

"Currently, a month’s supply of the originator version of dolutegravir alone costs almost that much in SA," Rutter said.

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