SANAC ON FIXED DOSED COMBINATION (FDCS)

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This month (April), some public sector AIDS patients started taking simplified ARV treatment of just one pill a day to manage their infection. The South African National AIDS Council (SANAC) welcomes this change in treatment protocols by the Department of Health.

“On behalf of men in South Africa and organisations working with men and boys, we welcome the good news by the Minister of Health that the national Health Department is introducing fixed dose combination (FDC) anti-retroviral (ARV) treatment. In the process of rolling out the once a day ARV tablet, which contains a combination of three vital ARVs – Tenofovir, Efavirenz and Emtricitabine – the ARV programme should improve through increased compliance and maintenance of patients on ARVs, including the introduction of new patients to ARVs”.

“Instead of taking several pills at different times of the day, the FDC allows for patients to take one pill once a day, which will improve adherence. We have to make sure that those who are still taking several pills remain in the system and stay motivated, said Rev Bafana Khumalo, the national chairperson of the men’s sector of the South African National AIDS Council (SANAC).
The People Living with HIV sector believes that FDC therapy will improve and strengthen adherence to treatment.

“There are many reasons why people do not adhere to their medication. Amongst them are issues of high dosages or too many pills to take (which is also known as pill burden) and side-effects. Too many people, about 70% in South Africa, have HIV and TB at the same time and in most cases they have to take treatment for both illnesses simultaneously. This means many of us take far too many pills and that discourages some not to take them. We need more simplified treatment to influence adherence. The introduction of fixed dose combination therapy is a very progressive step towards improving and reducing factors that contribute to poor adherence”, says Vuyiseka Dubula, an executive member of SANAC’s sector of people living with HIV.

Fixed dose combination therapy will also apply to pregnant women, thus replacing the dual combination therapy consisting of Nevirapine and AZT. All HIV-positive pregnant women in South Africa, during pregnancy and throughout the breast-feeding period, will be on fixed dose combination therapy regardless of their CD 4 count. This will continue even after breast-feeding if their CD 4 count falls below 350. In fact, pregnant women are a priority group and are the first in line to receive FDC therapy as the Health Department begins phasing in this treatment model.

“This is exciting news indeed that we are starting to see a breakthrough and shift for the significant improvement of health and well-being for all people living with HIV, especially mothers and children”, said an executive committee member of SANAC’s children’s sector, Anthony Ambrose.
“This is simplifying the way patients have become used to taking ARV treatment. Patients will now take one pill a day. This pill is an all-in-one package of all three anti-retrovirals (Tenofovir, Efavirenz and Emtricitabine) that a patient needs for optimal treatment. And they will take it once a day as opposed to taking a combination of pills three times a day”, says Dr Fareed Abdullah, chief executive officer (CEO) of the South African National AIDS Council (SANAC).

“We have come a very long way since the advent of anti-retrovirals. At one point, patients used to take up to 16 pills a day”, Dr Abdullah adds.
“This simplification of treatment makes taking AIDS treatment convenient. We hope that it will result in patients complying with and adhering to their treatment. We hope that this will enable many more patients to take their medication everywhere and anywhere they may be”, he says.

Professor Ashraf Coovadia, chairperson of SANAC’s children’s sector, advises that “it is important to inform the public that whilst government will be rolling out the new PMTCT programme with FDCs, the current PMTCT programme which utilises AZT & Nevirapine to mothers and Nevirapine to infants is still an effective strategy”.
According to SANAC CEO, Dr Abdullah, “not everybody will switch to one pill a day immediately, as the Department will roll this out over the coming months. Patients who are on second line treatment will not be switched to the one pill a day treatment. Patients should talk to their doctors and nurses to find out if and when they will switch treatment. There will always be some exceptions, but by this time next year the Health Minister expects that 80% of all patients will be on the new formulation”.
The rollout of the FDC therapy will be in two phases, with HIV-positive pregnant women, patients newly-initiated on ART and those who are coinfected with TB and HIV being prescribed FDCs in April. Patients who are already taking treatment will be switched to FDC therapy starting in July/August.

Abdullah noted that within SANAC there were some people who wanted everyone to start at the same time, but there was an understanding that there will be phases to the rollout.

“We appreciate the move by our government to introduce the FDC. But the government should equally put more efforts and ensure that we all get the same treatment”, said Mluleki Zazini, chairperson of the PLHIV sector.

But Zazini moved to make a call to all people living with HIV that are affected by the phasing in approach to “be patient and continue taking their current treatment, considering that their health will be compromised if they default”.

“The introduction of fixed dose combinations needs all of us to do social mobilisation to educate people about this change. We also have to make sure that our supply chain management is not interrupted so that we do not have stock-outs of medicines”, added Vuyiseka Dubula, of the PLHIV sector.


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