Speaking on the eve of World AIDS Day on Saturday, health minister Dr Aaron Motsoaledi announced in Pretoria on Thursday that a tender for the triple FDC of tenofovir, emtricitabine and efavirenz had been approved.
‘This in simple language means that a patient does not have to take 3 tablets a day and can now take 1 tablet once a day,’ explained Motsoaledi.
FDCs have shown to have major benefits for patients in terms of compliance. The price of the FDC is R89.37, with the minister claiming this made it the world’s lowest priced FDC.
‘It also means that logistics and storage are reduced; additionally there are fewer side effects with this combination,’ the Minister added.
Motsoaledi said the FDC brings with it an additional extraordinary benefit for pregnant HIV positive women. ‘Because of this new fixed dose combination from April 2013 all pregnant women will be given the fixed dose combination during pregnancy and breast feeding and thereafter if their CD4 count is less than 350. The fixed dose combination is more effective than dual therapy and has fewer side effects for the pregnant mother, in addition to its’ convenient dosage regimen.’
He confirmed that the majority of patients currently on the three ARV drugs would switch to the FDC from April 2013. Government will continue to stock the current ARVs for those unable to switch.
Professor Andrew Boulle of the University of Cape Town has been calling for FDCs for a number of years: ‘This is fantastic news and the health department should be commended for the stewardship they have shown with this tender.’
Boulle expressed the hope that the department will follow this up by ensuring that these FDCs are packaged in monthly adherence-promoting blister packs to help patients keep track of their medication.
MÃ©decins Sans FrontiÃ¨res/Doctors Without Borders (MSF) also welcomed the inclusion of FDCs.
‘The inclusion of FDCs is good news for the 1.7 million people currently on ARVs in South Africa, because they now finally have access to simpler and improved treatment options ‘ which significantly cuts down their daily pill burden from 3 to 5 pills down to just one,’ says Dr Gilles Van Cutsem, MSF’s medical coordinator in South Africa and Lesotho.
‘Rolling out drugs in FDC formulations will have significantly positive implications to help keep patients adherent to their life-long treatment.’
FDC formulations do not only benefit patients but also relieve the burden on the South African health system by simplifying the ordering and monitoring of ARV stocks. With fewer pills to pack, transport and dispense cost reductions are also possible.
Motsoaledi also announced a further reduction in the price of ARVs for South South Africa, the world’s biggest consumer of the drugs, with 21% of all ARVs administered here.
In the 2010 tender government was able to reduce the expenditure on ARVs by 53%. This was followed by the 18% saving on TB drugs.
The new tender is valued at R5.9-billion over two years. The state sector currently treats 1.7-million patients with a goal to expand this to 2.5million by the end of 2014. This new tender was initially expected to cost R8.1 billion based on prices of the current tender, however the health department was able to reduce the cost of the tender by 38% which is a saving of R2.2 billion.
‘This saving means we can treat more patients with the same budget,’ said Motsoaledi.
The health department awarded the tender for the FDC to three companies Aspen Pharmcare, Cipla Medpro and Mylan pharmaceuticals.
Motsoaledi said they split the quantities so that there is no interruption of supply if one supplier experiences problems.
Approximately 70% of the volume of the entire contract was awarded to local manufacturers.