From April 2023, all people with HIV who are more than four weeks old (and weigh more than three kilograms) will be able to follow a treatment plan that includes the antiretroviral (ARV) drug dolutegravir, according to Thato Chidarikire, the acting agent of the health department. . head of HIV programs.
Chidarikire spoke to Bhekisisa webinar on 7 December, during which the Society of HIV Clinicians of South Africa (SAHCS) showcased its 2023 (private sector) treatment guidelines for adults and children, which should also be available to the public early next year.
Dolutegravir, which was first recommended as first-line treatment in South Africa in 2019, is one of the ARV drugs in a three-in-one pill for first-line treatment. The other two drugs in the pill are tenofovir and lamivudine.
First-line treatment is the ARV combination that works best and has the fewest side effects as initial treatment for HIV infection. If the first-line treatment starts to work less well for some patients (if the virus in their body becomes resistant to the treatment), they switch to the second-line treatment.
Dolutegravir, which belongs to a group of ARVs called integrase inhibitors, replaces efavirenz in first-line treatment. Research shows that efavirenz is better than efavirenz at reducing the amount of HIV in a person’s blood to low enough levels that it can no longer be passed on to other people through sex (called viral suppression). Dolutegravir is also more forgiving of missed doses, reducing patients’ risk of developing drug resistance.
Finally, dolutegravir is cheaper than efavirenz and has fewer side effects.
The Department of Health began phasing in dolutegravir in December 2019.
From next year, the SAHCS will recommend dolutegravir not only for patients starting ARVs for the first time, but also for second- and third-line treatment, says Jeremy Nel, an infectious disease specialist based at the Hospital Helen Joseph of Johannesburg.
That’s good news, Nel says, because doctors often had to opt for more expensive and complicated drug prescriptions when patients had to follow second- and third-line treatment.
But getting people to buy into the new guidelines could prove tricky for health workers, Nel argues, as they will have to shake off the bad press they’ve received since the World Health Organization (WHO) first endorsed the use of medicine in 2018.
Researchers initially warned that the drug could cause birth defects if taken by pregnant women and that it leads to considerable weight gain.
Subsequent data, however, has cleared up both concerns, but communities remain uninformed and therefore fearful, says Luckyboy Mkhondwane, who leads the Treatment Action Campaign’s (TAC) HIV treatment and prevention education projects.
Reputational damage could be behind dolutegravir’s slow uptake in the private sector, says Nel, which has lagged behind government facilities.
But miscommunication and lack of training can also be to blame. Healthcare workers in the private sector had less information about dolutegravir dosing guidelines and potential side effects than their colleagues in government facilities, a 2022 study published in South African Medical Journal Found.
Mkhondwane explains: “If a doctor prescribes or talks about drugs that a patient has never heard of, it can intimidate patients and prevent them from asking questions.”
From strawberry-flavored HIV drugs for children to shedding dolutegravir’s bad rap, the updated guidelines promise positive changes in treatment for the 7.8 million people in South Africa living with HIV.
Here’s what you need to know.
- Why do both the health department and SAHCS have guidelines?
The guidelines consolidate the most recent, science-backed evidence for treating a disease into a standardized package, says Juliet Houghton, chief executive of SAHCS. That means health workers can give all patients the care that’s right for them, he says.
Because the public and private healthcare sectors serve different markets, each has its own guidelines: the Department of Health for state patients and the SAHCS document for private sector clients.
The health department may, for example, have a tighter budget that could affect its guidelines, Houghton explains.
But Nel stresses that the two sets are very similar, so people can get standardized care no matter which facility they use and know that their treatment won’t change dramatically if they switch sectors. In cases where the two documents differ, the SAHCS will explain its thinking.
For the new sets of guidelines, Houghton says, SAHCS and the health department are trying to align public and private sector guidelines more closely than before.
- Why are treatment guidelines changing?
Treatment guidelines evolve as better drugs and treatment plans emerge, Chidarikire says.
Under the country’s first set of treatment rules in 2004, for example, people could only receive HIV treatment if their CD4 count had dropped to 200 or less. A patient’s CD4 count is a measure of the strength of their immune system.
But today, anyone who tests positive for HIV can receive treatment.
Houghton says: “The bottom line is that the recommendations are updated to ensure that everyone in South Africa living with HIV receives the best care available.”
- What’s new for kids?
Caregivers of infants and children can expect simpler HIV treatment plans.
Current guidelines say that children 10 years of age and older (and who weigh at least 30 kilograms) should take the adult form of the drug.
But under the new plan, babies and children can take a child-friendly form of dolutegravir from four weeks of age (up to 10 years old), rather than having to stick with the older drugs, older ones, nevirapine and azidothymidine.
The children’s version of dolutegravir shows great promise.
It’s a four-in-one, strawberry-flavored pill that will replace the series of syrups that carers and health workers currently have to give children but struggle to get them to take.
Medicines taste bad, so “children don’t always get the full dose they need because they spit it out,” explains James Nuttall, from the University of Cape Town. They can also have side effects and must be given twice a day, which can be difficult for caregivers, she says.
The new dolutegravir pill recommended for children starting next year can be dissolved in water or sprinkled on soft food and only needs to be taken once a day. South Africa’s drug regulator, the Health Products Regulatory Authority of South Africa, approved this form of the drug in June.
Better treatment for children is a crucial step in controlling the HIV epidemic, says Nuttall.
Children fare much worse than adults when it comes to HIV treatment. One way to see the difference is to look at the two groups’ progress towards the 95-95-95 targets supported by the United Nations.
The goal is for countries to have diagnosed 95% of all HIV-positive people, to provide ARV therapy to 95% of people diagnosed, and to have the viral load of 95% of people treated drop to undetectable levels by 2030.
Overall, South Africa are on 94-78-89. But the picture changes dramatically when the numbers of children are separated: for those under 15, we are only between 80-69-64.
- Is dolutegravir safe to use during pregnancy?
“A word about that,” Nel says, “Yes.”
He continues: “They [ARVs] not only are they safe; they are essential.”
When a pregnant person has a lot of HIV in her blood, she passes the virus on to her baby, Nel says.
But dolutegravir’s ability to quickly lower someone’s viral load means it can prevent HIV from spreading from a mother to a baby. That’s why the health department currently recommends that all HIV-positive mothers be considered at high risk of passing the virus to their babies until proven otherwise, Chidarikire explains, and be on HIV treatment.
Nuttall concludes, “It would be great if pediatric HIV could be something we read about in books, rather than a condition we deal with every day.”
- Does dolutegravir cause weight gain?
One study suggested that people taking dolutegravir gain more weight than those taking efavirenz.
But new research from South Africa shows that it’s not dolutegravir itself that causes people to gain weight during treatment, Nel explains, it’s just their body’s normal reaction to getting back to health (because the virus has been practically thwarted).
The researchers also found that people who did not gain weight while taking efavirenz was likely because their bodies struggled to break down the drug quickly enough, which interferes with normal metabolism.
- Will any nurses be able to initiate people into HIV treatment and prevention?
At the moment, only nurses who have completed the so-called NIMART training program (which stands for nurse-initiated management of antiretroviral treatment) can prescribe and administer ARVs and prevention drugs such as the HIV Preventive Pill (currently available in South Africa) or the new bimonthly anti-HIV injection cabotegravir (not yet available in the country).
That won’t change under the health department’s new guidelines, Chidarikire says.
- Will testing guidelines for newborns change?
In 2015, the health department started using polymerase chain reaction (PCR) tests to determine a newborn’s HIV status, so they could start treatment as soon as possible if were contagious during pregnancy, explains Nuttall.
Newborns should be tested with PCR, rather than antibody tests (which are cheaper), because a positive antibody test does not make it clear whether the mother or the baby has HIV. Any baby born to an HIV-positive mother will test positive for the virus at first because the mother’s antibodies will be transferred to the fetus across the placenta.
A positive PCR test, on the other hand, means that the virus itself is present.
Nuttall says HIV-negative babies should be retested in the first year of life, in case they become infected while breastfeeding, and then can start treatment immediately.
This story was produced by the Bhekisisa Center for Health Journalism. Sign up for the newsletter.