TAC and NAPWA welcome introduction of FDC but cautions against stock-outs and slow roll-out

The Minister of Health, Dr Aaron Motsoaledi, announced in December last year that the Department of health will be rolling-out a Fixed Dose Combination (FDC) antiretroviral pill that combines three drugs into one. With this FDC many patients will only take one pill, once a day. This one pill contains the individual medicines Efavirenz (EFV), Tenofovir (TDF) and Emtricitabine FTC).
The Treatment Action Campaign (TAC) and the National Association of People Living with HIV/AIDS (NAPWA) welcome the introduction of this FDC into the public health sector. If introduced properly, this will benefit both patients and health care workers.
Benefits to patients include;

  • Reduced pill burden – taking one pill is considerably better that taking up to three to five pills a day. This will be even more beneficial to patients who have co-infections and those who have other chronic illnesses.
  • May improve treatment adherence – it is easier to remember to take one pill once a day than it is to remember to take multiple pills at least twice a day.

The FDC will also benefit health care workers because it will make it easier for them to place orders, store and dispense the medication.
The Department announced that the roll-out will be phased in according to priority groups.

  • Priority group 1 includes  all new patients starting ARVs for the first time
  • Priority group 2 includes HIV-positive pregnant women and breastfeeding mothers currently stable on 3TC, TDF and EFV
  • Priority group 3 includes patients that are currently on a Stavudine (d4T)-based regime
  • Priority group 4 includes stable patients receiving individual 3TC, TDF and EFV and who have tuberculosis (TB) co-infection (except drug resistant TB).
  • Priority group 5 includes stable patients receiving individual 3TC, TDF and EFV and who have other co-morbidities (e.g. hypertension, diabetes)
  • Priority group 6 includes patients receiving individual 3TC, TDF and EFV and who request to switch to the FDC treatment
  • Priority group 7 includes patients receiving individual 3TC, TDF and EFV and who, after counselling, agree to switch to the FDC treatment.

Not all patients will be eligible for the FDC. First line patients for whom Tenofovir or Efavirenz is not indicated will not be able to take the FDC. Patients receiving second line treatment are also not eligible for the FDC.
TAC and NAPWA have some concerns with the way FDCs are being rolled out. 
Communication with patients about the timing of the various phases of the rollout has been poor. Public announcements created the expectation that the pills will be widely available from April 1, but non-priority groups might have to wait many more months before being switched to the FDCs. Patients have not been given any indication as to when the various phases will be initiated and how long they will have to wait.
The National Department of Health must provide clear timelines for the introduction of FDCs. In addition, messages from the National Department of Health should be supplemented with more locally specific messages from provincial departments of health to avoid confusion and unmet expectations. 
The TAC has received reports that some health facilities have received only between 10 and 28 bottles of these pills. These are low numbers and raises serious questions about whether all who are eligible will be able to receive the FDC pills, particularly those in the first two priority groups.  
In addition, the TAC continues to receive reports of medicine shortages in health facilities, most notably from Gauteng and Mpumalanga. Whereas FDCs should make stock and supply-line management easier, it will not solve the much more fundamental management problems that are plaguing these two provinces in particular.
The TAC and NAPWA will continue to monitor the roll out of the FDC and the availability of this and other medicines in public health facilities.
For more information and for more information please contact;
Simonia Mashangoane- Treatment Action Campaign: 083 285 3846
Mluleki Zazini – NAPWA:  072 126 6666