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HIV BREAKTHROUGH: GET TWO INJECTIONS PER YEAR

30/06/2024 08:20:00 Mfanukhona Nkambule

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MBABANE – It is considered rare in any branch of medicine that a trial of a new drug can report 100 per cent efficacy, and a first in HIV science.

That is what happened when Gilead Sciences announced that no HIV infections had been seen among 2 134 young women and adolescent girls in South Africa and Uganda, after they had been administered twice-yearly injections of its innovative anti-HIV drug, lenacapavir, a pre-exposure prophylaxis (PrEP), in its Purpose I study. It is said that lenacapavir can be effective when it is administered every six months, making it the most durable HIV prevention method to have shown efficacy in the population. The top-line results released by Gilead Sciences showed that the twice-yearly injectable anti-HIV drug demonstrated 100 per cent efficacy. Phase III Purpose I trial took into account the investigational use of HIV prevention in cisgender women. Cisgender is a term that is used to describe people whose gender identity matches the sex they were assigned at birth. For example, someone who was assigned female at birth (AFAB) and identifies as a woman is a cisgender woman.

Efficacy

It is understood that Purpose I met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg). Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants. “With zero infections and 100 per cent efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, Chief Medical Officer, Gilead Sciences.

“We look forward to additional results from the ongoing purpose clinical programme and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.”
These are the first data generated from Gilead’s landmark purpose programme. This is the most comprehensive and diverse HIV prevention trial programme ever conducted. The purpose programme comprises five HIV prevention trials around the world, that are focused on innovation in science, trial design, community engagement and health equity. Purpose I, a Phase III, double-blind, randomised study, is evaluating the safety and efficacy of twice-yearly, subcutaneous lenacapavir for PrEP and once-daily oral Descovy in more than 5 300 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda.

The drugs are being tested in parallel, with one group receiving twice-yearly lenacapavir and one group taking once-daily oral Descovy. Additionally, a third group was assigned once-daily oral Truvada. The use of lenacapavir and the use of Descovy for the prevention of HIV in cisgender women are investigational and have not been determined to be safe or efficacious and are not approved anywhere globally.

Assessing

Gilead expects results in late 2024/early 2025 from the programme’s other pivotal trial, purpose II, which is assessing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender men and transgender women. This also include gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States. The regulatory filing for lenacapavir for PrEP will include the results of both Purpose I and Purpose II. Gilead said it was committed to partnering with communities that were disproportionately affected by HIV in their respective countries and regions. The company said it recognised the importance of helping to enable access in order for twice-yearly lenacapavir for PrEP, if approved by regulatory authorities, to achieve the broadest impact.

Meanwhile, organisations throughout the world are welcoming the groundbreaking results of the Purpose One HIV prevention study. In a statement released to the Times of Eswatini SUNDAY by AVAC, the results were encouraging. The independent data and safety monitoring Board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with no infections seen among trial participants who received injectable lenacapavir.

Prevention

“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, AVAC’s Executive Director. Warren said the addition of HIV prevention options meant more people might find an option ‘that is right for them’. Beyond expanded choice, he said a twice-yearly injection has the potential to transform the way they, as experts, could deliver HIV prevention to people who needed and wanted it most. This is from an easier to follow regimen for individuals, to a decreased burden on healthcare systems that are stretched to the limit. He said they expected to see a timeline that would take into account a full analysis of purpose 1 data and the coming data from purpose II from Gilead as soon as possible.

The executive director urged regulatory agencies to prepare to fast track regulatory review and also called on the World Health Organisation (WHO) to be prepared to quickly include lenacapavir, if approved by regulatory agencies, in HIV prevention guidelines. “There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact and expand the toolbox of HIV prevention choices,” he said. Warren pointed out that AVAC and a cadre of international partners have been working together to plan for a successful and accelerated introduction of lenacapavir.

Since oral PrEP was first shown to be safe and effective 14 years ago, he said the global health community has failed in delivering PrEP at scale and with equity, adding that they had, therefore, not seen the impact that they needed. He said the lessons from the past were clear, advising that they needed to act on them and move with speed, scale and urgency. “There can be no excuses and no delays,” said Warren.

Normative

He said they were looking forward to working with civil society partners, Gilead, international donors, normative agencies and national governments to ensure that this groundbreaking HIV prevention option was made available as quickly as possible. He warned against squandering this opportunity to drive down new HIV infections. Nandisile Sikwana, the Regional Stakeholder Engagement for AVAC, said they were incredibly excited about this result, especially about what it could mean for women in Africa. Sikwana is a member of the purpose 1 Global Community Advisory Group. She applauded Gilead’s commitment to good participatory practice in this and the other purpose studies. Dr. Velephi Okello, the Director of Health Services in the Ministry of Health, could not be reached for comment by the time this report was finalised yesterday. Khanya Mabuza, the Principal Secretary in the Ministry of Health was also unavailable to indicate whether they were aware of the results of the trial and what it means for Eswatini.