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South Africa: Fixed Dose Combination ARVs Rolled Out
Source: www.sanews.gov.za
Source Date: Thursday, April 11, 2013
Focus: ICT for MDGs, Citizen Engagement
Country: South Africa
Created: Apr 11, 2013

With the new pill, patients will now be taking one tablet once a day instead of three to five pills a day.

Launching the single tablet, Motsoaledi said the department has revised the guidelines for the Prevention of Mother to Child Transmission (PMTCT), paediatric and adult treatment due to changes in the treatment regime to FDC ARVs.

The fixed-dose combination -- containing emtricitabine, efavirenz and tenofovir -- is a multiple antiretroviral drug combined into a single pill, which helps reduce pill burden. It is easy to take, highly effective and in no way inferior to taking three individual drugs.

“We also decided that all pregnant HIV positive women will be started on the FDC, regardless of their CD4 count. They will stay on treatment until they complete breastfeeding. They will continue on treatment should their CD4 count be 350 or below.

“More than 7 000 doctors and nurses have been updated on the new guidelines and we’ve ensured that at least one [or two] health care professionals in each facility have been updated,” Motsoaledi said.

In addition, more than 200 master trainers have been trained, including those based at regional training centres, as well as those stationed at the department’s development partners.

Motsoaledi explained that the eligible patients will get one month’s supply of FDC pills for the first three months.

“They will see their clinicians monthly for three months so that they can be carefully monitored. Thereafter, if they are stable they, will be given three months’ supply of FDCs.

“From June onwards, all other stable, non-complicated patients will be switched to FDCs after consultation with their clinicians,” he explained.

A pregnancy register has been introduced at selected sites to conduct surveillance on adverse drug reactions. Motsoaledi emphasised that this was not because they were anticipating any adverse events, but it was good clinical practice to do so, standard all over the world.

“We need to carefully monitor reactions of patients on drugs and take action when we see any systematic adverse events.”

Motsoaledi said he was confident that they had sufficient supplies of ARVs for all patients who are eligible for the FDC pills. The department had been working with three suppliers to ensure that they are able to supply them the requisite quantities without disruption.

“In order to ensure uninterrupted supply of ARV medicines on the new tender, the national Department of Health has initiated monthly supplier meetings to discuss forecasted demand for the following three months so that manufacturers can plan their manufacturing accordingly.”

Motsoaledi said that data has been collected from provincial depots on a weekly basis and analysed in order to identify weaknesses in the supply chain, which are then addressed either with the province or the supplier, depending on the nature of the problem.

To date, 389 857 units of FDC pills have been supplied to the provinces. A further 915 000 units are expected to be delivered during the course of April.

The volume units are expected to increase to 1.5 million per month by September this year to allow all patients -- including switching existing, stable patients currently taking three individual ARV drugs -- to have access to the FDC pills.

Currently, 1.7 million patients are on ARV treatment and the department hopes to expand this to 2.5 million by the end of 2014.

One of the first beneficiaries of the FDC pills, Andrew Mosane (26) from Ga-Rankuwa Zone 4, is the Gauteng secretary for the Treatment Action Campaign. Mosane said the new drug will make his life easier.

“It’s going to be less stress than taking five tablets a day and everybody will have access to it. [This will] improve peoples’ lives," said an elated Mosane.
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