HIV: ‘Vaccine’ for prevention could emerge in the next decade – 10/10/2023 – Health

A vaccine-like drug administered once a year to prevent HIV could be ready as soon as 2030, according to drug maker ViiV, transforming the treatment of a virus that has killed nearly 40 million people into an epidemic lasting more than four decades.

Although there is no vaccine to treat HIV, a virus that can lead to AIDS, pre-exposure prophylaxis (PrEP) has reduced transmission rates by offering protection to those who may be exposed to the virus.

Most PrEP therapies rely on daily oral medication intake or when unprotected sex occurs, but the possible emergence of a preventative medication with characteristics of a vaccine could drastically reduce the burden on patients and health authorities globally.

HIV drug developer ViiV is accelerating research into VH184, an antiretroviral drug designed to block the action of the integrase enzyme, which inserts the genetic code of the HIV virus into host cell DNA.

Kimberly Smith, head of research and development at ViiV, said a long-acting drug administered every 12 months will soon be achievable: “I can’t say when, but not much later than the end of this decade. It will be possible, I believe.”

“[VH184] has demonstrated a very long half-life in preclinical studies,” she told the Financial Times. “We need to determine whether this very long half-life translates to humans.”

Long-acting medications are administered intramuscularly monthly or less frequently, releasing chemicals over a long period of time. Meg Doherty, head of the World Health Organization’s (WHO) HIV program, said ViiV’s long-acting drug under discussion is “exciting” but emphasized the need to ensure low-cost universal coverage.

“It will be important to continue to ensure that these prevention treatments [de HIV] and new approaches are available to everyone, including people living in low- and middle-income countries,” she said.

ViiV, a company controlled by GSK in partnership with Pfizer of the US and Shionogi of Japan, told investors in late September that it increased its sales growth projection to between 6% and 8% between 2021 and 2026, as that its focus on long-acting medications compensates for the “patent gap” — or loss of exclusivity — of its highly successful oral treatment, the antiretroviral drug dolutegravir.

The company has two long-acting drugs based on cabotegravir, another integrase inhibitor, approved by regulators: cabenuva, in combination with another molecule, for the treatment of patients who have contracted HIV, and its PrEP drug Apretude. These non-oral products are generally taken monthly or every other month.

Smith said people started saying Apretude is “almost like a vaccine… basically you get the dose and then you don’t have to think about it anymore, as opposed to having to take something every day.”

“Certainly the longer we spend with these intervals, the more it feels like that,” he added, comparing it to annual flu and Covid-19 vaccines. US-based Gilead is also developing long-acting treatments for HIV.

While ViiV CEO Deborah Waterhouse said there has been strong uptake of long-acting PrEP medications in the US, the situation has been mixed in the European Union despite regulatory approval.

Reimbursement needs to be negotiated with each country individually, and although some governments have shown interest, many have not made requests because they have managed to control the HIV case burden with cheaper oral treatments.

Access to long-acting medicines in poorer nations with high HIV rates remains patchy despite the signing of licenses for their generic manufacture. The NGO Doctors Without Borders refused to sign a confidentiality agreement on prices requested by ViiV for an access agreement in Mozambique and other countries.

Waterhouse said he is looking to find middle ground with MSF and reach a resolution “because we want them to be partners.”

“It will be a shame if there is a repeat of what we see now with [PrEP de ação prolongada]where people in Africa, with the highest HIV burden, have little access to it for prevention,” said WHO’s Doherty.