26 March 2013

South Africa: Gauteng Health Ready for 'One Pill Once a Day'

press release

The Gauteng Department of Health has trained all is pharmacists, ordered sufficient stock for Priority 1 category patients and is ready to roll out the fixed-dose combination (FDC) of antiretrovirals from the 1st of April 2013 to all persons receiving and those who are still going to be initiated on ARVs.

Fixed-dose combination of antiretroviral - emtricitabine, efavirenz and tenofovir - are multiple antiretroviral drugs combined into a single pill, which helps reduce the pill burden. The Minister of Health Dr Aaron Motsoaledi announced in December of 2012 of the inclusion of fixed-dose combination for use in the first line treatment of HIV positive people. This move, he said, is to improve adherence and patient outcomes.

"Patients will benefit from FDC because it simplifies treatment, cutting down the number of tablets that a person has to take daily," says MEC Hope Papo. "They also allow patients to take their medication more discreetly if that is what they prefer to do. With one-pill-a-day FDC, adhering to your antiretroviral therapy is as simple as taking any other tablet."

Initially, FDC will be produced in smaller quantities with production expected to increase over time as pharmaceutical producers expand their productive capacity. In order to phase in FDC smoothly patients have been grouped into seven categories for prioritisation in the FDC initiation/switch.

The first priority group are new patients, adults, adolescents and pregnant women, who are eligible to start antiretroviral treatment. The second priority will be all pregnant women needing triple therapy as well as breastfeeding mothers currently stable on a FDC compatible regimen. The third priority will be those who are virally suppressed currently on first line regimen requiring a switch due to toxicity of, for an example, stavudine.

The other priority groups are the following;

  • Priority four: people currently stable on a FDC compatible regimen with tuberculosis co-infection;
  • Priority five: patients currently stable on a FDC compatible regimen with other illnesses such as hypertension, diabetes mellitus, etc;
  • Priority six: patients currently stable on Tenofovir Disoproxil Formulate (TDF)-based regimen and who request a switch to a FDC; and
  • Priority seven: patients currently stable on TDF-based regimen who, after counselling, agree to a switch to a FDC.

The fixed dose combination is one pill to be taken once daily in the place of three daily tablets (tenofovir, emtricitabine and efavirenz). Although the FDC is 'one pill once a day', it does contain three different ARV medications. "It is easy to take, highly effective and in no way inferior to taking three individual drugs," explains MEC Papo.

Most patients initiating the FDC, he continued, should not encounter problems, but if they experience any significant side effects, they are urged to consult the healthcare provider. Although the FDC is a larger tablet, it is not significantly larger than any usual tablet; therefore swallowing should not create problems. "There is no liquid FDC formulation currently on the market. Crushing or dissolving the FDC, which undermines bio-equivalence, should be avoided."

"We have emphasised the need to counsel all patients, especially the stable ones, who are not included in the priority groups for the FDC so that they understand why they are not being switched to an easier option," concluded MEC Papo.

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