Lenacapavir can end new infections before 2030—scientists

 

On December 1, 2024, Uganda joined the rest of the world to commemorate World AIDS Day. In the run-up to the day, New Vision highlighted some of Uganda’s milestones in the fight against HIV and AIDS and related issues. In this article, John Musenze highlights the progress in finding a cure.

Good news! In a recent HIV study, one of the drugs under trial demonstrated an efficacy of 100% offering protection to HIV-negative individuals. The drug, Lenacapavir, is an injectable HIV prevention drug (PrEP) that is administered twice a year. The drug was developed by Gilead Sciences, Inc., a US-based pharmaceutical company and the trial was conducted in Uganda and South Africa.

 The study, called the PURPOSE 1 trial, which began in 2021, was conducted among 5,300 adolescent girls and young women aged 16-25 at high risk of HIV infection at 28 sites in Uganda and South Africa.

In Uganda, the study was conducted at Makerere University-John Hopkins University research collaboration (MU-JHU) Care Ltd as the national co-ordinating institution.  The trial sites included Mityana, Makerere-Kalangala and AMBSO Masaka with MU-JHU.

Lenacapavir is a game-changer in the global fight against HIV, according to Dr Flavia Matovu Kiweewa, the study’s lead researcher in Uganda. Its 100% effectiveness in trials makes it a potentially powerful tool in the fight against HIV globally, according to Kiweewa, also the director of research at MU-JHU Care Ltd.

 “It is the first time we are seeing zero infections in any study,” Kiweewa says.

The injectable comes at a time when there is a stiff rise in new HIV infections. 

“It could help people who might not be able to take tablets daily or use condoms and those at high risk of getting HIV,” she adds.

Explaining how the trial was conducted, Kiweewa says the selection criteria were girls and women at high risk of HIV infection. These included barmaids, women who exchange sex for money and those with multiple sexual partners.

PURPOSE 1 Study MUJHU Mityana Site. (Credit: MU-JHU)

“All the girls who were screened for the study had perceived themselves to be infected with HIV. They could not believe that they were HIV-negative. These are the kind of girls we targeted for the PURPOSE 1 study; girls who could have daily celebrations that a day has passed, and they are still HIV-negative,” Kiweewa says.

How each drug performed

The twice-yearly injection of the drug lenacapavir can provide total protection against HIV infections, demonstrating 100% efficacy in Phase 3 trial data released by drugmaker Gilead.

Among the women and girls, the researchers assessed how many HIV infections occurred over 26 weeks, none of the 2,134 women in the Lenacapavir group acquired HIV. But there were 16 incident cases among 1,068 women in the Truvada group (incidence 1.69 per 100 person-years) and 39 of the 2,136 women (2.02 per 100 person-years) who received Descovy acquired HIV.

“In the trial, Lenacapavir was generally well-tolerated, and no significant or new safety concerns were identified," reads a press release from Gilead Sciences Inc. on June 20, 2024.

This trial showed Lenacapavir’s high efficacy, sparking excitement among researchers who believe it could revolutionise both the prevention and treatment of HIV — a condition that affects over 1.5 million people in Uganda and 40 million globally according to the 2023 UNAIDS report. 

Ministry of health permanent secretary Diana Atwine. (Credit: John Musenze)

“We are hopeful that within about two years, we will have access to Lenacapavir in Uganda, once all required approval processes are completed both at the international and national levels. With the drug, we can get close to elimination of new HIV infections,” Kiweewa says.

Another potential benefit of Lenacapavir is addressing the stigma some people face when taking oral PrEP pills, according to Dr Matovu Kiweewa. She adds that the treatment could also increase PrEP adherence as one is injected only twice a year. 

However, this breakthrough will not be impactful if the product is not easily accessible. “We want to make sure that these innovations and breakthroughs reach the people who need them as soon as possible,” Kiweewa explained.

Six companies to manufacture the drug

Gilead Sciences, Inc., which sponsored this research, has already signed royalty-free voluntary licensing agreements with six generic drug manufacturers. This, Kiweewa says will increase access to Lenacapavir for HIV prevention in high-incidence and resource-limited settings.

Gilead is committed to ensuring the dedicated supply of Lenacapavir in 18 countries where the need is greatest, including Uganda and South Africa, until generic versions are available.

This development puts Uganda at the forefront of global efforts to fight HIV, ensuring that the country will be among the first to benefit from this life-saving innovation.

“We believe all the approvals will be done and we hope to have this miracle drug ready within two years because there are many approvals to be done by global health stakeholders like drug authority, WHO among others. Then Uganda's National Drug Authority will have it for approval for Ugandans to use,” Kiweewa said.

Other options against HIV  

Other drugs used in the fight against HIV and AIDS include oral Pre-exposure prophylaxis (PrEP), Post Exposure Prophylaxis (PEP), long-acting injectable cabotegravir (CAB-LA) and the dapivirine ring, a ring made from silicone which is inserted in the vigina containing the anti-HIV drug that can protect women for 28 days.

All these are viable options until Lenacapavir becomes more widely available.

Aside from medical interventions, Uganda's success in reducing HIV transmission is also attributable to the ABC (abstinence, be faithful, use condoms) approach.

Noteworthy is that Uganda's ABC approach has been adopted by other countries, making it a model for HIV prevention like Kenya, South Africa and Botswana.

"ABC is still the best. However, there has been a significant increase in new infections, especially among young people," health ministry permanent secretary Dr Diana Atwine says.  One factor she blames for this trend is a decline in condom use. Combatting this calls for continued education and awareness campaigns.

Relatedly, Atwine cautions the young people that much as there are anti-HIV drugs like PEP and PrEP, there are risks that might not be prevented like unwanted pregnancy, infections and cancer of the cervix.

Dr. Flavia Matovu Kiweewa, Uganda National Principal Investigator with Linda-Gail Bekker, National Principal Investigator South Africa following release of the PURPOSE 1 results at IAS 2024, M. (Credit: MU-JHU)

World Leaders laud Uganda’s on Lenacapavir

Winnie Byanyima, the executive director of UNAIDS

At the AIDS Conference 2024 in Germany, she said it is possible that “the AIDS epidemic will cease to be a public health threat by 2030. Lenacapavir is a transformative tool. It could see us accelerate and achieve a sustainable development goal of 2030: Ending AIDS as a public health threat.

Dr Beatriz Grinsztejn, International AIDS Society

“We need to bring the results of our research to the people who need it most. It's not enough to just do research. We need to make sure that it's used to help people."

She lauded Ugandan scientists for bringing the game-charger not just to Uganda but to the global community.

Mitchell Warren, executive director of AVAC

He commended Uganda’s strategies in the HIV fight and believes Lenacapavir is among the most important results we’ve seen to date of any HIV prevention option.

“Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it. Stakeholders must move expeditiously, scale and equity in delivering Lenacapavir, so we don’t squander this opportunity to drive down new HIV infections".

US committed to Uganda’s HIV fight

As Uganda strives to achieve epidemic control by 2030, collaboration between the United States and Uganda is critical in addressing the pressing health issue.

The election of Donald Trump back in office has created uncertainty for many people in the HIV globally including Ugandan scientists and organisations.

Ellen Masi, the US Mission Uganda Public Affairs Consular, reassured stakeholders that funding for HIV services in Uganda would not be disrupted.

The US government is proceeding with the approved two-year PEPFAR Country Operational Plan 2023 to ensure life-saving assistance continues to benefit the people of Uganda, Masi said. This assistance will support HIV prevention and treatment services, testing and laboratory support, essential medicines and health workers.

Regarding Lenacapavir, Masi said both the Government of Uganda and US Global AIDS co-ordinator ambassador Nkengasong are encouraged by its results, promising that it will be included in the arsenal of HIV prevention.

In the same breath, she called for broadening access to HIV services, emphasising that success in ending HIV as a public health threat by 2030 would require an inclusive approach, that is access to HIV services to all.

HIV statistics

Uganda has made progress in combating HIV/AIDS. With over 1.49 million people with the HIV and AIDS and 1.3 million people on ARVs and 95% suppressing their viral load according to 2023 UNAIDS report.

UNAIDS 2023 data reveals while 77% of youth living with HIV receive treatment, only 90% have achieved viral suppression, with a concerning disparity among males, where only 55% have reached this critical health milestone.

Fact file

MU-JHU, which was founded in 1988, initially conducted research in prevention of mother-to-child transmission. This reduced the risk of passing on HIV from mothers to their babies during pregnancy at birth or even through breastfeeding.

According to the Uganda Aids Commission, this has been a success, with a dramatic reduction of HIV infections among newborns by 77%, from 20,000 cases in 2010 to 5,900 cases in 2022.