Novel drug furthers UNAIDS stride to achieve 95-95-95 goal

South Africa, a country with some of the highest HIV/Aids rates in the world (14,75%), has taken big strides towards achieving, surpassing, and maintaining the global 95-95-95 HIV/Aids goals as launched by the Joint United Nations Programme on HIV/Aids (UNAIDS) in 2020. This effort aims to have 95% of people with HIV/Aids know their status, 95% of these people receive ART, and 95% of them achieve viral suppression. While the country keeps growing towards better understanding and accepting HIV/Aids, new treatment regimens also mean patients are less likely to become resistant to their medication.

Found guilty of more than 700 charges linked to his child sex abuse ring, kingpin Gerhard Ackerman was sentenced to 12 life sentences on 14 August. Acting judge and senior advocate Paul Kennedy – who, before dying by suicide, was also charged in connection with the crimes – was in contact with three teenagers Ackerman supplied, one being a 15-year-old boy.

The teen now has HIV/Aids. Despite treatment, the victim is reportedly “gravely ill” and at risk of kidney failure.

According to the South African Government, 8,2 million South Africans were living with HIV/Aids in 2021. Approximately 28,7 million of the 38,4 million people across the globe living with HIV/Aids receive antiretroviral therapy (ART), of which 10% prove drug resistant, according to the World Health Organisation (WHO).

In contrast, eight out of ten multi-drug resistant patients on the antiretroviral, Sunlenca, have undetectable levels of HIV. Approved by the Food and Drug Administration (FDA) in December 2022, the capsule/injectable developed by the American biopharmaceutical company, Gilead, could help people with HIV/Aids who have run out of treatment options.

The active ingredient in Sunlenca is lenacapavir which, according to North-West University (NWU) lecturer and pharmacist Dr Stephan Steyn, represents a new class of antiretroviral drugs, meaning that its mechanism of action is different to that of other drugs prescribed to people living with HIV/Aids.

“Lenacapavir prevents viral replication by interfering with multiple and essential steps of the viral lifecycle,” he says.

Lenacapavir specifically targets the capsid or “shell” of the virus, rendering it “effective against viruses that have developed resistance towards other classes of ART drugs that target different enzymes or steps of the replication process”.

With an acceptable safety profile, injection sites administering lenacapavir most frequently report hyperglycaemia (increased blood sugar) and altered liver function. Patients will initially start on oral tablets, and then switch to a routine injection every six months. 

READ | Zackie Achmat’s role in the availability of ART today

With lenacapavir’s advantages clearly outlined, Steyn says that the drug’s Achilles’ heel lies in its novelty. It is a double-edged sword as its effectiveness against resistant infections is invaluable, yet it could result in viral resistance in people with HIV/Aids.

In other words, a healthy person who gets a resistant strain of the HI virus is more at risk than someone who is infected with a non-resistant or “sensitive” organism. This could be fatal to a person with HIV/Aids.

However, because lenacapavir is part of a three-drug approach, the risk of viral resistance is reduced.

To prevent a scenario in which there are no further alternatives beyond lenacapavir – in essence, a pre-ART period – the drug is to be used responsibly or limited in an effort to prevent misuse.

It is unclear when Sunlenca will be readily available in South Africa, though Steyn expects it to come at high costs as is the case with any novel drug or innovator. “Because of the prevalence of HIV/Aids in South Africa and the country’s investment in the battle against this pandemic, I would assume that negotiations will take place on the necessary government levels to perhaps subsidise a percentage of the costs.”

As first-line HIV/Aids treatments prove mostly effective, Sunlenca could be valuable in the development of other ART drugs. Steyn believes the discovery of a capsid inhibitor is a novel way to combat HIV/Aids, one that may lead to other novel drug discoveries.

Steyn emphasises the continued need for awareness programmes and education regarding this topic, especially on the all-too-common obstacle of access to antiretroviral healthcare. Accordingly, organisations such as The Southern African HIV/Aids Clinicians Society have an accredited post-graduate qualification for pharmacists, equipping them with the knowledge and skills to test and prescribe first-line ART.

According to Steyn, South Africa prioritises access to HIV/Aids testing and treatment by developing programmes such as PIMART and NIMART (pharmacists and nurses that can prescribe ART) that expand the number of healthcare professionals in the field, leading to easier access to anti-HIV/Aids treatments, including pre-and post-exposure prophylaxis (PrEP and PEP).

“The Aids Rebel”

“I will not take expensive treatment until all ordinary South Africans can get it on the public health system.” These words of HIV/Aids positive Zackie Achmat heralded the world’s first drug strike in 1999. According to The New Yorker, when the president at the time, Thabo Mbeki, wrote the HIV/Aids epidemic off as the result of mass poverty and malnutrition, ART was available in South Africa at eight times the cost of the generic in India.

“The poorest of the poor are dying, only the rich have access to treatment. My fight is essentially about this. If we don’t have morals in our politics, then South Africa is doomed,” said Achmat, who weighed his life and his cause and made a clear choice. The New Yorker referred to “The Aids Rebel” as “the most important dissident in the country since Nelson Mandela” in 2003.

As of 2004, ART is available for free at public healthcare facilities in South Africa. Such distribution helped raise the life expectancy in South Africa from 49 to 60 years. The South African government is responsible for the rollout, but the thanks go to those who coaxed its hand.