Lima, Peru Global health specialists assert that affordability and widespread distribution are essential for the success of a durable injectable HIV prevention medicine that has demonstrated significant efficacy in human studies.
The US pharmaceutical giant Gilead Sciences is pursuing regulatory approval for the medicine lenacapavir in several African nations, a crucial step towards its availability in an area where nearly one in 25 individuals is living with HIV.
Lenacapavir is a long-acting pre-exposure prophylaxis (PrEP) that prevents HIV from entering the body and replicating.
In contrast to oral PrEP therapies, which require daily ingestion, this medicine is provided at six-month intervals and is the longest-acting injectable developed to date.
In a late-stage experiment, Lenacapavir diminished HIV transmission by 96 percent among various demographics, including males who have sex with men, as well as transgender and non-binary individuals.
According to statistics presented at the International AIDS Society’s HIV Research for Prevention Conference in Lima, Peru, earlier this month, only two individuals out of over 2,000 participants in the PURPOSE 2 research subsequently contracted HIV.
The results extend the previous PURPOSE 1 trial, which indicated that no cisgender women—individuals who identify with their assigned gender at birth—contracted HIV while using the medication.
Hasina Subedar, senior technical advisor at South Africa’s Department of Health, asserts that the practical implications of lenacapavir will be contingent upon the drug’s affordability and accessibility.
“If affordable, lenacapavir could markedly decrease new infections in this region,” she stated.
According to Colleen Kelley, associate professor of Medicine at Emory University in the US, the biannual administration of the pill may address the adherence challenges associated with oral PrEP.
She posits that lenacapavir may be especially advantageous in regions with limited healthcare access, characterizing it as a “highly effective instrument for HIV prevention that does not rely on daily oral compliance.”
Objective of one million
Mitchell Warren, executive director of AVAC, a non-profit organization dedicated to fair access to HIV prevention choices, described the drug’s potential as “remarkable” while underscoring the necessity of assuring widespread distribution.
“We demand a vigorous initiative to ensure lenacapavir is accessible to a minimum of one million individuals in low- and middle-income nations within the inaugural year of its deployment,” Warren stated.
He emphasized that extensive production and a resilient supply network were crucial for delivering the medicine to people in most need.
In Africa, where healthcare systems frequently face challenges, the expense of treatment is a significant issue.
Gilead has established voluntary licensing arrangements to permit the manufacture of generic lenacapavir; nevertheless, the pricing framework is still ambiguous.
Preliminary simulations indicate that for general use, an annual supply of lenacapavir should be priced at approximately US$40, akin to the cost of oral PrEP.
Warren asserts that nations such as Zambia and Kenya, with prior experience in executing HIV prevention programs, are anticipated to be early adopters and will serve as a litmus test for real-world efficacy. If effective, this may stimulate demand for the generic variant and subsequently reduce the price over time.
Gilead Sciences intends to initiate regulatory procedures by the conclusion of 2024 in 18 low- and middle-income nations with a significant HIV prevalence, including Botswana, Kenya, Uganda, South Africa, Nigeria, Tanzania, Zambia, and Malawi.
The business has established non-exclusive, royalty-free license arrangements with six generic manufacturers, including Dr. Reddy’s, Emcure, and Mylan, to make and distribute generic versions of lenacapavir in 120 resource-limited countries, aiming to facilitate low-cost access.
Gilead has stated its intention to supply the medicine at no profit until generic producers can adequately meet demand.
“Considering the transformative potential of lenacapavir for prevention, our priority is to ensure its rapid and widespread availability in areas of greatest need,” stated Daniel O’Day, chairman and chief executive officer of Gilead.
“Gilead teams are diligently collaborating with high-volume generic manufacturers to facilitate a swift transition to these voluntary license partners following the approval of lenacapavir for PrEP,” he stated.
Gilead asserts it is operating within regulatory structures, including the European Medicines Agency’s EU Medicines for All program, to accelerate country-level drug approval and WHO pre-qualification.
The medicine has received permission in Europe and the United States for the treatment of HIV/AIDS, but it lacks regulatory approval globally.
Establishing trust
Warren indicated that, once licensed, generating a sufficient supply of lenacapavir to establish a dependable supply chain in Africa may pose a considerable hurdle.
He asserts that prior PrEP implementations have demonstrated the need of constant availability to establish and sustain community confidence.
Concerns exist over the likelihood of patients returning for their treatments biannually.
“The prospects are exhilarating, yet numerous inquiries remain,” remarked Warren.
Chilufya Kasanda, representing Zambia’s Treatment Advocacy and Literacy Campaign, emphasized the necessity of providing a variety of treatment alternatives.
“The community’s desire and appetite are substantial; however, we must acknowledge that communities will continually evolve their perspectives on products,” stated Kasanda.
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