Gauteng ready to roll out fixed-dose ARVs

Tuesday, March 26, 2013

Pretoria - The Gauteng Department of Health says it is ready to roll out the fixed-dose combination (FDC) of antiretrovirals from 1 April 2013, to all those receiving and those who are still going to be initiated on ARVs.

The department says it has trained all its pharmacists and has ordered sufficient stock for Priority 1 category patients.

Health Minister Dr Aaron Motsoaledi announced in December 2012 the inclusion of the fixed-dose combination for use in the first-line treatment of HIV positive people. This move, he said, is to improve adherence to treatment and patient outcomes.

The fixed-dose combination of the antiretrovirals - emtricitabine, efavirenz and tenofovir – is combined into a single pill, which helps to reduce the pill burden on patients.

"Patients will benefit from FDC because it simplifies treatment, cutting down the number of tablets that a person has to take daily," said Gauteng Health MEC Hope Papo.

"It also allows patients to take their medication more discreetly if that is what they prefer to do. With the one-pill-a-day FDC, adhering to your antiretroviral therapy is as simple as taking any other tablet.

"It is easy to take, highly effective and in no way inferior to taking three individual drugs."

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 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
Priority seven: patients currently stable on TDF-based regimen who, after counselling, agree to a switch to a FDC.

Most patients starting on FDC, Papo said, should not encounter problems. However, if they experience any significant side-effects, they are urged to consult a healthcare provider.

Although the FDC is a larger tablet, it is not significantly larger than any usual tablet. Ingesting the tablet 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," cautioned Papo.

"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," Papo said. – SAnews.gov.za