Professor Ashraf Coovadia, a paediatrician with a special interest in HIV care in children and chairperson of the Yezingane Network, the South African National AIDS Council’s Children’s Sector, spoke to SANAC NEWS about the benefits of FDC usage in pregnant women.
Pregnant HIV-positive women are among the first candidates to receive fixed dose combination (FDC) tablets. The use of FDCs is part of the government’s revised PMTCT programme commenced in the public health sector in April this year. FDC therapy consists of one pill, which has a combination of three different antiretrovirals – efavirenz, emtricitabine and tenofovir – and is taken once a day, eliminating the need for people to take multiple pills at different times. The introduction of FDC therapy as part of the country’s treatment guidelines has been hailed as a progressive move.
Why is there so much excitement about the introduction of FDCs?
This is a product that the HIV community has been asking to be made available for a long time now. It’s not a new product at all. The earliest FDCs came in the form of Combivir, which was dual therapy containing both AZT (zidovudine) and
3TC (lamivudine) or another dual combination, Abacavir and 3TC in one tablet. FDCs are also not limited to AIDS treatment. Patients on treatment for tuberculosis (TB) often have a 3 in 1 tablet or a 4 in 1 tablet, which makes for easier administration by the patients. The AIDS community wanted to take a leaf out of TB treatment, so to speak. We wanted to see if the pharmacology of three drugs combined into one was possible. And, yes, it’s proven to be possible. The resource-rich countries, not surprisingly, were the first to have these and it was just a matter of time before we got it. The major reason we haven’t had them earlier is because of cost implications. We couldn’t afford them and these drugs had to be registered by the Medicines Control Council (MCC) prior to use in the country.
What are the advantages of this form of treatment?
The drugs that are combined in the FDC tablet are neither new nor superior to the individual drugs that we have been using. The difference is that they are more convenient to take in this form. Added to this convenience is the ability to take it only once per day. We hope and expect that adherence will become better as a result of having only one pill to take. We also hope that the supply management chain will be better in that with the FDCs, which are manufactured by several drug manufacturers, we’ll now deal with reduced overall volumes. However, this remains to be seen. With individual combination therapy, you need to supply a number of different medicines from different manufacturers with varying production or supply challenges. Stock-outs of just one of these drugs in the triple therapy cocktail are problematic for the patient. With FDCs you do not run the risk of giving only one or two of the necessary antiretroviral drugs and, thus, theoretically the risk of people developing resistance to certain medicines is lower.
How does this compare with the previous prophylacticmethod to prevent mother to child HIV transmission?
What has changed with the latest revision of the PMTCT Guidelines of March 2013, is the following: • All HIV-infected women will be commenced onto the triple therapy regimen HAART (Highly active antiretroviral therapy), irrespective of their CD4 count. Previously, only those with CD4 counts less than 350cells/ml were started on HAART. • HAART will be commenced in all these women on the day of diagnosis so as to avoid any delays in treatment.
Do all pregnant women automatically qualify for FDC therapy?
According to the new guidelines, all HIV-infected women need to go onto antiretroviral therapy. The vast majority of these women will qualify for therapy with an FDC. There are a few women who will not be able to go onto FDC therapy if they are found to have any kidney disease or poorly functioning kidneys. Additionally, any woman who has any serious psychiatric illness will also not be started on FDCs, but would be given alternative antiretroviral drugs. All patients on antiretroviral therapy need to be followed up closely to monitor for side-effects as well as to ensure that the best outcomes for both mother and baby are achieved. Women on FDCs will need to have their kidney function monitored as a small percentage of patients on this drug could develop kidney complications like renal failure. This is avoidable if monitoring is done and prompt stoppage occurs.
How can the introduction of FDC therapy improve our PMTCT outcomes?
In 2001, with mono-therapy (Nevirapine), the best we could have hoped for was to reduce mother-to-child HIV transmission to about 10% , that is, one in 10 HIV-infected mothers would have an infected infant. In 2008, our target was less than 5% reduction, using dual therapy – AZT and Nevirapine. In 2010, we reduced transmission down to less than 5 %. We hope that FDC therapy is going to improve adherence, as it will make it easier for mothers to keep on taking their medication for longer periods with, hopefully, better outcomes for both mothers and babies.