Fixed-dose combination ARVs: Everything you need to know

Background
In late 2012 the Minister of Health, Dr Aaron Motsoaledi, announced that fixed-dose combination (FDC) antiretroviral drugs (ARVs) will be used in the first line treatment of HIV-positive patients from 1 April 2013.

This fact sheet explains everything that civil society needs to know about the changeover to fixed-dose combination ARVs – how it impacts on civil society sectors and their constituents.

What is a fixed-dose combination ARV?

Fixed dose combination, or FDC as it will be referred to from this point, is a combination of two or more active drugs in a single pill.

The FDC ARV that will be rolled out in South Africa is a single tablet which contains a combination of the tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV).

Why was the decision made to change over to FDC in favour of South Africa’s current regimen?

FDC is simpler, more effective and cheaper than the current regimen. The National Department of Health managed to negotiate R89.37 per month for FDC treatment. This is a significant saving from the old, single-drug tender.  

What is the difference between FDC and the current ART regimen?

With the introduction of FDC, all new patients, pregnant women and breastfeeding mothers will be offered FDC.

The main difference between FDC and the current ART regimen is that these patients will have to one pill once a day instead of three or more pills multiple times a day.

What are the benefits of the changeover to FDC for patients?

The changeover to FDC will have a major impact on the quality of lives of people living with HIV in South Africa.

FDC is more convenient, easier to take and with fewer side effects. The patient will also have to undergo fewer laboratory tests once he/she is on treatment.

As a result of all of these benefits, we hope that adherence to ARVs will improve.

What do the guideline changes mean for women and children?

All HIV positive pregnant women, regardless of their CD4 count, will start FDC from 14 weeks of pregnancy and continue throughout the breastfeeding period.

Following the breast feeding period, women with CD4 counts less than 350 will continue on FDC for life. We hope that this will reduce mother-to-child transmission during the infant feeding period.

What are the benefits of the changeover to FDC for health care workers?

FDC will be easier to order, store and manage than the current regimen. The logistics around supply chain management will be simplified. Health workers themselves who are recently trained in the initiation and management of ART will have a simpler training curriculum and daily work. Relationships with patients may improve with a regimen that is easier to explain and manage.

But there are so many stock outs of ARVs as is. How is government going to handle this changeover?

Government cannot do this alone. Stock outs occur because demand outstrips supply and because of poor communication between the facilities and the National Department of Health. This must change. We need facility staff to monitor and order their supply of FDC effectively and communicate with NDoH before stock outs occur. We need health care workers – nurses, doctors and clinicians – to adhere to the new guidelines to make sure we don’t overextend ourselves beyond the current tender.

The Department of Health has made a commitment to rolling out FDC because it believes that they have a major benefit to people living with HIV in South Africa. We acknowledge that there have been challenges with stock outs, but in fact, in the long run FDC will make procurement and supply chain management easier.

We need all leadership across South African society mobilise communities to help us to address the challenges in the health system. For instance, we need everyone – civil society, traditional and community leadership, the faith-based sector and people living with HIV – to spread the word so that women book early for antenatal care and can benefit from FDC. This will make the difference.

Why won’t all people currently on HIV treatment benefit from FDC immediately?

It is precisely to avoid stock outs that we have to use a phased approach. Under the 2013/4 tender, the manufacturer can supply us with 30 million units in phases. We currently have 1.9 million people on ARVs. There simply is not enough availability to start with. Thus, priority will be given to new patients, all pregnant and breastfeeding women because that is where we believe we can have the quickest and greatest impact, not only keeping people alive, but reducing new HIV infections among infants. As more FDC ARVs become available, priority patients 3–5 will be phased in.

Depending on availability, we hope we can offer all people in priority groups 6 and 7 FDC within a year.

So everyone on HIV treatment will eventually be on FDC?

Some people may not be able to take the one combination ARV pill because their condition may be more complicated. Persons who have failed their first antiretroviral regimen will not be able to take FDCs. In addition, those who have problems with their kidneys or who have severe psychiatric conditions will not able to take the FDC. 

Priority 1: New patients (adults, adolescents and pregnant women) eligible to

Priority 2: All pregnant women needing triple therapy and breast feeding mothers currently stable on a FDC compatible regimen.

Priority 3: Virally suppressed patients currently on first line regimen, requiring a switch due to toxicity (e.g. stavudine).

Priority 4: Patients currently stable on a TDF-based regimen, with TB comorbidity.

Priority 5: Patients currently stable on a TDF-based regimen, with other comorbidities (e.g. hypertension, diabetes mellitus, etc.).

Priority 6: patients currently stable on Tenofovir Disoproxil Formulate (TDF)-based regimen and who request a switch to a FDC

Priority 7: patients currently stable on TDF-based regimen who, after counselling, agree to a switch to a FDC

 

SPREAD THE WORD ABOUT FDC TO PEOPLE WHO NEED ARVs:

What you can say to new patients about FDC:

  • Most people who learn that they are HIV positive for the first time and who need to take ARVs can take one combination pill (FDC) once a day.
  • Some HIV-positive people may not be able to take the one combination ARV pill because their condition may be more complicated.
  • The combined one pill ARV has the same effect as taking the three ARVs as separate pills.
  • Taking one combined dose of ARV a day will make it easier for you to take your treatment everyday

What you can say to everyone routinely:

  • Test for TB if you are HIV positive
  • Test for HIV if you have TB
  • Use a condom every time you have sex, regardless of your HIV status
  • Get tested together with every new sexual partner you have
  • Share your HIV status with your partner and encourage your partner to share his/her HIV status with you
  • Go for medical male circumcision

 

 

What you can say to women routinely:

  • It is better for you and your baby’s health to plan your pregnancy.
  • Know your HIV status and that of your partner before you fall pregnant. 
  • Visit the clinic as soon as you think you may be pregnant, regardless of whether the pregnancy is planned or unintended.
  • At the clinic, the health care worker will do a pregnancy test.
  • If you are pregnant, the health care worker will refer you for a booking at the antenatal clinic.
  • You will be offered HIV Counselling and Testing (HCT).

What you can say to pregnant women routinely:

  • Book at an antenatal clinic before you are 14 weeks pregnant.
  • Have an HIV test before you are 14 weeks pregnant and then again at 32 weeks.
  • Share your HIV status with your partner and encourage him to do the same.
  • Use a condom every time you have sex.

 

What you can say to a pregnant woman who tests HIV positive:

  • Unless there are complications, you will be given the new single dose combination ARV pill on the same day you test HIV positive.
  • The clinic staff will take blood for more laboratory tests but they do not have to wait for these test results before they start you on treatment. You must return after seven days for these results.
  • The one pill that contains a combination of ARVs must be taken once a day.
  • Taking this one combined ARV pill has the same effect as taking three separate ARV pills.
  • This one pill taken once a day by will protect your health and prevent your unborn baby from getting HIV.

 

You can say to a pregnant woman about her HIV treatment:

  • Depending on the test results, your long-term HIV treatment will be decided:
  • If your CD4 count is below 350, you will be offered lifelong HIV treatment
  • If your CD count is above 350, you will be offered HIV treatment throughout your pregnancy until one week after you stop breastfeeding.
  • If you are already on AZT and pregnant, you will be changed to the combination one pill ARV.
  • If you are on triple therapy and taking three pills, you will be changed over to the combination one pill ARV.
  • If you are diagnosed during labour you will be given a dose of Nevirapine, Truvada and AZT every three hours. If you are planning to breastfeed, you will start on a combination one pill ARV as soon as possible.

What you can say to breastfeeding mothers:

  • Exclusive breastfeeding is best for your baby’s health.
  • If you are HIV positive you can safely breastfeed if you continue to take one combined ARV pill for as long as you breastfeed your baby.
  • Take your baby to the clinic when he/she is six weeks old to be immunised and to have an HIV test.
  • Take your baby for another HIV test once you have stopped breastfeeding.
  • Always use a condom when engaging in sexual activity.
  • Choose and start using a family planning method soon as you resume sexual activity after the birth of your baby.