From April 1, HIV positive people on antiretroviral therapy will be able to take one pill a day, instead of three pills twice a day.
Pregnant women with HIV will also be put onto this ‘triple fixed-dose combination’ pill, no matter how strong their immune systems (CD4 count), for the duration of pregnancy and breastfeeding to protect their babies from HIV. Pregnant women with CD4 counts of less than 350 would remain on ARVs for life.
The single pill is thanks to a new government tender that comes into effect next month for a generic that combines the three first-line ARVs, tenofovir, emtricitabine (FTC) and efavirenz, into one pill. Three different ARVs ‘ or triple therapy – are needed to keep HIV in check effectively and to avoid patients developing drug resistance.
Health Minister Dr Aaron Motsoaledi said this week the government had moved over to FDC treatment because ‘it is much easier for patients to take their ARVs’.
‘We are prioritizing new patients and pregnant women for the fixed-dose combination (FDC) pill treatment,’ said Motsoaledi. ‘For those who are already on antiretroviral therapy, we will leave it up to their doctors to decide whether to change them over.’
Describing the FDC pill as ‘excellent news for patients’, MÃ©decins Sans FrontiÃ¨res spokesperson Kate Ribet said it would ‘improve adherence and thus reduce the risk of treatment failure and drug resistance’.
‘It is easier to plan, order, prescribe, dispense and monitor adherence of one combination drug than three separate ones. This is critical given the history of stock outs and the lack of pharmacists and pharmacist assistants,’ added Ribet.
Welcoming the single pill, the SA HIV Clinicians’ Society, said it:
* Reduces the risk of incorrect dosing due to patient misunderstanding, prescribing or dispensing errors;
* Patients are unable to default single drugs to avoid certain side-effects (for example, some patients independently discontinue efavirenz because of dizziness or drowsiness);
‘¢ There is a reduced risk of patient exposure to dual therapy during single drug stock-outs.
‘For me, the best thing about the FDC is that it will not be possible to run out of one of the three antiretroviral drugs,’ said Dr Francesca Conradie, president of the SA HIV Clinicians’ Society. ‘We have been beset with drug stock outs. If stocks allow, which is the challenge, then patients will never be given two of their three drugs.’
Vuyiseka Dubula, general secretary of the Treatment Action Campaign, (TAC) said the FDC would mean a reduction in the ‘pill burden’ for people and improve the likelihood of people taking their treatment.
‘About 70% of people in South Africa have HIV have TB at the same time and have to take treatment for both illnesses at the same time. This means many of us take far too many pills and that discourages some not to take them,’ said Dubula.
Dubula said not everyone would get the new single pill, as some patients were on different regimens and government had also prioritized access.
‘For example, I am taking AZT not efavirenz, and I am responding well to my treatment so I will continue to take it, not the FDC,’ said Dubula. ‘The most important thing is that we need to take our medication regularly without interruptions.’
The first patients to get the FDCs will be pregnant women and new patients, according to the health department’s priority list.
However, Conradie said she was concerned that there was no viral load testing for pregnant women who were only on ARVs to protect their babies from HIV (those with CD4 counts higher than 350). This measures the level of HIV in a person’s blood, and only if the viral load is undetectable is the treatment considered to be working.
‘If the women are not fully adherent and have a detectable viral load, all of us, both mothers and healthcare workers, will have a false sense of security. They also do not have a viral load test done at the end of breastfeeding, so we have no idea if when we introduce ART either for the next pregnancy or when she needs it for her own health, if it is likely to work,’ said Conradie.
‘Proper communication to staff and patients is critical and needs to be well prepared so that women understand the importance to continue FDC ARVs during the whole duration of breastfeeding,’ said Ribet.
Meanwhile, Gauteng’s Department of Health announced this week that it had trained all its pharmacists and ‘is ready to roll out the FDC from the 1st of April’.
Aside from making treatment easier, “the FDC also allow patients to take their medication more discreetly if that is what they prefer to do,’ said Gauteng MEC Hope Papo. ‘ Health-e News Service