Starting in April 2023, everyone with HIV older than four weeks (and weighing more than three kilograms) will be able to follow a treatment plan that includes the antiretroviral (ARV) drug dolutegravir, according to Thato Chidarikire, acting director of the department of Health. head of HIV programs
Chidarikire was speaking in a Bhekisisa webinar on 7 December, during which the Southern African Society of HIV Clinicians (SAHCS) previewed its 2023 treatment guidelines (private sector) for adults and children, which also They should 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 first-line treatment starts to work less well for some patients (if the virus in their bodies becomes resistant to treatment), they are switched to second-line treatment.
Dolutegravir, which belongs to a group of ARVs called integrase inhibitors, replaces efavirenz in first-line treatment. Research shows that it is better than efavirenz at reducing the amount of HIV in a person’s blood to levels low enough that it can no longer be passed to other people through sexual intercourse (called viral suppression). . Dolutegravir is also more forgiving of missed doses, which reduces the risk of patients developing drug resistance.
Finally, dolutegravir is cheaper than efavirenz and has fewer side effects.
The health department began phasing in dolutegravir in December 2019.
Starting 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 at Helen Joseph Hospital in Johannesburg.
This is good news, Nel says, because doctors often had to opt for more expensive and complicated drug prescriptions when patients had to switch to second- and third-line treatment.
But getting people to accept the new guidelines could be difficult for health workers, Nel argues, as they will have to undo the bad press dolutegravir has received since the World Health Organization (WHO) first endorsed its use. of the drug in 2018.
The researchers initially warned that the drug could cause birth defects if taken by pregnant women and that it leads to significant weight gain.
However, subsequent data clarified both concerns, but communities remain uninformed and therefore fearful, says Luckyboy Mkhondwane, who leads the Treatment Action Campaign (TAC) education projects for treatment and HIV prevention.
Reputational damage could be behind the slow adoption of dolutegravir in the private sector, says Nel, which has lagged behind government facilities.
But poor communication and a lack of training can also be to blame. Healthcare workers in the private sector had less information about dolutegravir dosing guidelines and possible side effects than their peers in government facilities, according to a 2022 study published in the journal South African Medical Journal found.
Mkhondwane explains: “If a doctor prescribes or talks about a drug that a patient has never heard of, it can intimidate patients and prevent them from asking questions.”
From strawberry-flavoured HIV medicines for children to undoing dolutegravir’s bad reputation, the updated guidelines promise positive changes in the treatment of the 7.8 million people living with HIV in South Africa.
Here’s what you need to know.
- Why do both the health department and SAHCS have guidelines?
The guidelines consolidate the latest science-backed evidence for treating a disease into a standardized package, explains SAHCS Executive Director Juliet Houghton. This means healthcare workers can give all patients the best care for them, she says.
Because the public and private health sectors serve different markets, each has its own guidelines: the health department guidelines 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 at whatever facility they use and know that their treatment won’t change dramatically, should they switch sectors. In cases where the two documents differ, SAHCS will explain its thinking.
For the new sets of guidelines, Houghton says, SAHCS and the health department are trying to align the guidelines from the public and private sectors more than before.
- Why do treatment guidelines change?
Treatment guidelines evolve as better medications and treatment plans emerge, Chidarikire says.
Under the country’s first set of treatment rules from 2004, for example, people could only receive HIV treatment if their CD4 count had dropped to 200 or below. A patient’s CD4 count is a measure of how strong their immune system is.
But today, anyone who tests positive for HIV can receive treatment.
Says Houghton: “The bottom line is that the recommendations are updated to ensure that all people living with HIV in South Africa receive the best available care.”
- What’s new for kids?
Caregivers of newborns and children can expect simpler HIV treatment plans.
Current guidelines say that children 10 years and older (and who weigh at least 30 kilograms) should take the adult form of the drug.
But with the new plan, infants and children can take a child-safe form of dolutegravir from the age of four weeks (up to age 10), rather than sticking with the older drugs nevirapine and azidothymidine.
The child-friendly version of dolutegravir shows great promise.
Why?
It’s a strawberry-flavored four-in-one pill that will replace the series of syrups that caregivers and healthcare workers currently have to give children but struggle to get them to take.
The medicines taste bad, which is why “children don’t always get the full dose they need because they spit it out,” explains James Nuttall of the University of Cape Town. They can also have side effects and must be administered twice a day, which can be difficult for caregivers, he says.
The new recommended dolutegravir tablet for children from next year can be dissolved in water or sprinkled on soft food and should be taken only once a day. South Africa’s drug regulator, the South African Health Products Regulatory Authority, approved this form of the drug in June.
Better treatment for children is a crucial step in bringing the HIV epidemic under control, Nuttall says.
Children fare much worse than adults when it comes to HIV treatment. One way to see the difference is to look at the progress of the two groups in reaching the 95-95-95 targets endorsed by the United Nations.
The goal is for countries to have diagnosed 95% of all people with HIV positive, provide ARV therapy to 95% of people diagnosed, and reduce the viral load of 95% of people receiving treatment to undetectable levels by 2030.
Overall, South Africa sits at 94-78-89. But the picture changes drastically when you break out the kids’ numbers: For kids under 15, we’re at just 80-69-64.
- Is it safe to use dolutegravir during pregnancy?
“A word on that,” says Nel: “Yes.”
He continues: “They [ARVs] they are not only safe; they are essential.”
When a pregnant woman has a lot of HIV in her blood, she passes the virus to her baby, says Nel.
But dolutegravir’s ability to quickly lower a person’s viral load means it can prevent HIV from spreading from mother to baby. That’s why the health department currently recommends that all HIV-positive mothers be considered at high risk of transmitting the virus to their babies until proven otherwise, Chidarikire explains, and they are 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?
Nope.
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 while on treatment, Nel explains, it’s just your body’s normal reaction to get healthy (because the virus has been practically frustrated).
The researchers also found that people who don’t gain weight while taking efavirenz is likely because their bodies struggled to break down the drug fast enough, which interferes with normal metabolism.
- Will any nurse be able to introduce people to HIV treatment and prevention?
Nope.
At the moment, only nurses who have completed the so-called NIMART (which stands for Nurse Initiated Antiretroviral Treatment Management) training program can prescribe and administer ARVs and preventive drugs such as the HIV prevention pill (currently available in South Africa) or the new biweekly anti-HIV injection cabotegravir (not yet available in the country).
That won’t change under the new health department guidelines, Chidarikire says.
- Will the testing guidelines for newborns change?
Nope.
In 2015, the health department began using polymerase chain reaction (PCR) tests to determine the HIV status of newborns so they could start treatment as soon as possible if they became infected during pregnancy, she explains. Nuttall.
Newborns should be given PCR tests, rather than antibody tests (which are cheaper), because with a positive antibody test it is not clear whether the mother or the baby has HIV. Any baby born to an HIV-positive mother will initially be positive for the virus because the mother’s antibodies will be transferred to the fetus through the placenta.
A positive PCR test, on the other hand, means that the virus itself is present.
Nuttall says that HIV-negative babies should be retested in their first year of life, in case they become infected while breastfeeding, and can then start treatment immediately.
This story was produced by the Bhekisisa Center for Health Journalism. Sign up for the Newsletter.
