First Cheaper Version of HIV Prevention Injection Lenacapavir Approved

A twice-a-year HIV prevention injection called lenacapavir has moved a step closer to people in low and middle income countries, with a cheaper version winning tentative US approval just 16 months after the original.

For people who find it hard to take HIV prevention pills every day, it could offer another way to stay protected without relying on daily pills.

On Monday 2 November 2026, the United States Food and Drug Administration (FDA), the American government's medicines regulator, gave that approval to the first cheaper copy, made by Dr. Reddy's Laboratories, an Indian drug company.

It is expected to be supplied at about $40 a person a year in 120 low and middle income countries.

How the approval came so quickly

The original injection is made by Gilead Sciences, an American company.

The FDA approved it for HIV prevention in June 2025, and the cheaper copy followed just 16 months later, the Clinton Health Access Initiative (CHAI) and Unitaid said in a joint statement.

CHAI is a global health organisation that works with governments and private companies in low and middle income countries to strengthen health systems, and it helped back the project. Unitaid is a global health agency hosted by the World Health Organization (WHO).

Dr. Neil Buddy Shah, CHAI's chief executive, said it came "rather than a decade later."

Several things helped.

In late 2024, Gilead gave six other companies licences to make the medicine, and Dr. Reddy's is one of them.

In September 2025, Unitaid, CHAI and Wits RHI agreed a price with Dr. Reddy's and promised money, technical help and support with its application to the FDA.

Wits RHI is the research institute of the University of the Witwatersrand in South Africa.

A twice-yearly injection offers another choice beyond pills

Pills taken to prevent HIV, known as PrEP, are widely used.

They are usually taken every day, though some people can take them only around sex, depending on their situation.

Lenacapavir adds a longer-acting choice.

According to the FDA-approved prescribing information for the original injection, Yeztugo, revised in June 2025, a person starts with two injections and two tablets on the first day and two more tablets on the second.

After that, they get two injections every six months.

People must test negative for HIV before starting and before each injection, the same document says.

Shah said that asking someone to take a pill every day to prevent a disease they do not have is hard, and that injections twice a year change that.

Africa already has the original injection

Gilead's own injection reached African clinics well before the cheaper copy.

Eswatini, a small country in southern Africa, was the first to give it, in December 2025, and it has since been rolled out in nine African countries: Eswatini, Kenya, Lesotho, Mozambique, Nigeria, South Africa, Uganda, Zambia and Zimbabwe, aidsmap, an HIV news website, reported from the AIDS 2026 conference in Rio de Janeiro in July.

By then 191,620 doses had been delivered across the nine countries, and supply was tight, including in Eswatini, where the plan had stalled.

In September, the Joint United Nations Programme on HIV/AIDS (UNAIDS), the United Nations programme on HIV, said it was working with Zambia's government, communities and international partners to help extend access there.

CHAI and Unitaid said on 2 November that more than 125,000 people in 10 early adopter African countries have started Gilead's original injection, and called demand strong.

Gilead's chief executive, Daniel O'Day, said the company supplies it at no profit to the US government's global HIV programme and the Global Fund, an international fund that pays for HIV, TB and malaria programmes.

South Africa: the biggest epidemic, and a launch in Secunda

South Africa has the world's largest HIV epidemic, with an estimated 7.9 million people living with the virus, according to UNAIDS.

The Department of Health said 37,920 doses arrived on 7 April 2026, and President Cyril Ramaphosa launched the national programme on 5 June in Secunda, a town in Mpumalanga province.

Jane Mndebele, a 21-year-old

woman, became the first South African to receive the injection.

"I am excited," she said after Health Minister Aaron Motsoaledi himself gave her the dose, UNAIDS reported.

The programme began at 360 public health facilities in 24 high-burden districts across six provinces.

By 7 September, more than 55,123 people had started the injection, the department said. Gauteng, the province around Johannesburg and Pretoria, recorded more than 26,000, and KwaZulu-Natal, on the east coast, about 11,900.

Some 71% of recipients were women, mostly pregnant and breastfeeding women.

The injection is offered alongside other HIV prevention options, so that figure describes who got it, not how many eligible women were reached.

Kenya: first in East Africa to give the shot

Kenya received its first shipment of 21,000 starter doses on 17 February 2026, delivered in partnership with the Global Fund, according to the Ministry of Health.

A further 12,000 continuation doses were expected by April, with another 25,000 doses from the US government planned.

Kenya launched the injection on 26 February at Riruta Health Centre in Nairobi, in a ceremony led by Health Cabinet Secretary Aden Duale.

WHO Kenya said Kenya is the first country in East Africa to roll it out.

The injection is free at selected public health facilities, in 12 Nairobi sub-counties, and is also being rolled out in counties including Kisumu, Mombasa, Nakuru and Migori.

The first doses were secured through partner support, with plans to raise Kenya's own funding over time.

Kenya is one of the 18 first priority countries Gilead named in 2024, so it is among the places the cheaper copy is meant to reach. None of the sources said when Kenya will get it or at what price.

Who the $40 price covers

CHAI said the $40 a person a year price applies to the 120 low and middle income countries covered by Gilead's licences.

It is the supply price under the partnership agreement, and the statement did not say what a patient or a government will pay in the end.

Most of the 120 are low and lower middle income, Gilead said in 2024, meaning countries with smaller economies where health budgets are tight.

When Gilead announced the plan in October 2024, it named 18 countries as its first priority, including Kenya, Nigeria, South Africa, Tanzania, Uganda, Zambia and Zimbabwe. Gilead said those 18 carry about 70% of the HIV burden across the 120 countries covered.

Why clinics will not have the cheaper copy tomorrow

The cheaper copy is not in African clinics yet.

The injections given so far are Gilead's original product.

CHAI and Unitaid said the first supplies of the cheaper copy are expected to reach countries before the end of 2026, with wider supply in 2027.

The groups are working with governments, the Global Fund, the Gates Foundation and other partners to get it to people, including through each country's own approval.

Professor Saiqa Mullick of Wits RHI said a cheap drug alone is not enough.

Countries also need health systems ready to give it, health workers confident in offering it, and communities taking part from the start.

The size of the need

An estimated 1.2 million people acquired HIV worldwide in 2025, according to UNAIDS. The estimate has an uncertainty range of 950,000 to 1.7 million.

The tentative approval clears one hurdle on the way to a cheaper injection.

Whether it reaches the people who need it will depend on national approvals, money to buy it and clinics able to test and inject.