No One Who Got the Twice a Year Lenacapavir Injection Caught HIV ,New Trial Data Shows

None of the people who received the twice-yearly HIV prevention injection lenacapavir acquired HIV during a one-year trial in the United Kingdom and France.

Meanwhile, 85.6% remained on the injection for the full year, compared with 46.3% of those taking daily prevention tablets, according to results released by Gilead Sciences, the company that makes the medicine, on 6 November 2026.

The findings highlight a potential advantage of long-acting HIV prevention medicines: people do not have to remember to take a tablet every day.

Instead, they receive injections twice a year after the initial starting doses.

Although the trial took place outside Africa, more than 125,000 people in 10 African countries have already started lenacapavir, according to Unitaid, an international health agency that helps poorer countries access new medicines.

The journal Science named lenacapavir its 2024 Breakthrough of the Year.

Gilead's latest findings provide new evidence about how consistently people use the injection compared with daily tablets, but the study also has important limitations when comparing the two medicines.

What the trial found

The trial, called PURPOSE 5, found that more people continued using the twice-yearly injection as scheduled than daily prevention tablets.

Of the 180 people assigned to lenacapavir, 154 (85.6%) remained on it for the full 52 weeks.

Among the 80 people assigned to daily tablets, 37 (46.3%) met the study's definition of continued use.

The difference was 39.3 percentage points, meaning substantially more people in the injection group remained on prevention throughout the study.

Gilead reported that the difference was statistically significant, meaning it was unlikely to have occurred by chance alone.

No one in the lenacapavir group acquired HIV during the study.

One person in the daily tablet group acquired the virus.

Blood tests at diagnosis suggested that the person had taken fewer than two tablets a week.

However, one infection in one group and none in the other are too few to establish which medicine was better at preventing HIV in this particular trial.

The study was designed primarily to measure how consistently participants remained on prevention, not to compare the medicines' effectiveness in preventing infections.

The trial enrolled 267 people in the UK and France who needed HIV prevention but were not taking PrEP when they joined.

Participants were randomly assigned, in a two-to-one ratio, to receive either the injection or daily tablets, and they knew which option they were receiving because the study was open-label.

Gilead's reported figures account for 180 people in the injection group and 80 in the tablet group, a total of 260.

The company did not explain the difference between this number and the 267 people enrolled.

Two groups, counted in two different ways

Although both groups were assessed on whether they continued using HIV prevention, researchers used different methods to measure this.

People receiving lenacapavir counted as remaining on prevention if they received their injections on schedule at the beginning of the study and again at week 26, and attended their final visit at week 52.

For people taking daily tablets, researchers used blood tests at weeks 13, 26, 39 and 52.

These tests measured traces of the medicine in their blood to determine whether participants had been taking enough tablets to meet the study's requirement of at least four doses a week.

This means the injection group was assessed mainly through attendance at scheduled visits, while the tablet group was assessed through evidence of medicine in their blood.

The two percentages therefore reflect different measures of continued use.

PURPOSE 5 was a phase 2 study, and 37.8% of participants had never used HIV prevention medicine before joining.

The findings are due to be presented at HIV Glasgow 2026, a medical conference taking place in Glasgow, Scotland, from 8 to 11 November.

No one in Kenya or elsewhere in Africa took part in the trial, so the findings do not directly establish how people using the injection in African health programmes will continue with it.

What is lenacapavir, and is it a cure?

Lenacapavir is a medicine used to reduce the risk of acquiring HIV in people who do not have the virus.

This type of prevention is called pre-exposure prophylaxis, or PrEP.

PrEP involves taking medicine before possible exposure to HIV to reduce the chances of becoming infected.

It can be taken as daily tablets or, with lenacapavir, through injections given once every six months.

Unlike daily PrEP tablets, which require people to remember to take medicine every day, lenacapavir offers protection through scheduled clinic visits twice a year after the initial doses.

This may make prevention easier for people who struggle with daily medication, although they must still attend their appointments on time.

It is not a vaccine and does not cure HIV.

People already living with HIV must continue taking their prescribed HIV treatment.

Dr Patrick Amoth, Kenya's Director General for Health, emphasised this when the first doses arrived in the country in February and urged people already receiving HIV treatment to continue taking their medicines.

The daily tablet used in PURPOSE 5 was F/TDF( sold under the brand name Truvada).

It is the most commonly used oral PrEP medicine globally, according to Gilead.

The company said daily tablets work well when taken as prescribed, but many people stop using them within a year.

About 1.2 million people worldwide acquired HIV in 2025, according to UNAIDS, the Joint United Nations Programme on HIV/AIDS.

The World Health Organization (WHO) recommended lenacapavir in July 2025 as an additional HIV prevention option for people at substantial risk of infection.

Kenya became the first country in East Africa to introduce the injection. Its Pharmacy and Poisons Board registered both the injectable and oral formulations in January 2026, the Ministry of Health said.

Where lenacapavir is being used across Africa

Ten African countries have started introducing lenacapavir for HIV prevention, with more than 125,000 people already started on the medicine, Unitaid said on 2 November 2026.

Reports from the AIDS 2026 conference in July named nine of the countries: Eswatini, Kenya, Lesotho, Mozambique, Nigeria, South Africa, Uganda, Zambia and Zimbabwe. The Clinton Health Access Initiative identifies Malawi as the tenth early adopter.

Eswatini and Zambia launched the programme on 1 December 2025, according to the Clinton Health Access Initiative.

Kenya's national launch followed on 26 February 2026.

In Uganda, distribution began in April, a month behind schedule, and an estimated 980 people had started the injection by mid-August, NPR reported.

South Africa launched nationally on 5 June.

Its Department of Health reported that more than 55,000 people had started lenacapavir by 7 September, across about 360 public health facilities.

In July, aidsmap reported that 191,620 doses had been delivered across nine African countries, about 14% of the more than one million planned for 2026.

Nearly 66,000 people had newly started the medicine across 900 sites.

The figures highlighted a challenge facing the rollout: demand for the injection was outpacing available supplies in some places.

A cheaper generic version is also on the way.

Dr. Reddy's Laboratories,an Indian Pharmaceutical company secured tentative US Food and Drug Administration approval for the first generic(cheaper) injectable version of lenacapavir on November 2, 2026 in a development that could improve access to the injection.

Under an agreement involving Unitaid, the Clinton Health Access Initiative and Wits RHI, the generic is expected to cost $40 per person per year in 120 eligible low- and middle-income countries.

Unitaid said the first supplies are expected to reach countries before the end of 2026, with broader availability in 2027.

However, the agreed price does not mean the medicine will immediately be available in every eligible country.

National regulatory processes, procurement and distribution will also determine when people can access it.

Who can get it in Kenya?

Lenacapavir for HIV prevention is intended for people who test negative for HIV and need protection against infection.

Kenya's National AIDS and STI Control Programme (NASCOP) requires an HIV test before the first dose.

The Standard reported that clients must also have had no possible exposure to the virus in the previous 72 hours.

Testing is particularly important because lenacapavir used alone for prevention is not a complete HIV treatment regimen.

Gilead's prescribing and safety information carries a boxed warning about the risk of drug resistance in people who unknowingly have HIV when they start the medicine.

If someone already has HIV but does not know it, using lenacapavir alone can allow drug-resistant forms of the virus to develop.

This can make it harder to treat the infection with certain medicines.

For this reason, people must test negative before starting the injection and undergo repeat HIV testing before subsequent injections.

New enrolment in Kenya was paused in late August because of shortages.

Defrontera, an independent Kenyan health newsroom, reported on 26 August that NASCOP had stopped enrolling new clients until fresh supplies arrived.

Dr Barbara Mambo, NASCOP's head of HIV prevention, said the remaining stock was being reserved for people who had started the injections in February, March and April so they could complete their scheduled doses.

Defrontera's analysis of supply data found that only 993 doses remained across the 15 counties on that day. Busia, Kisumu, Kakamega, Machakos, Migori and Kajiado had completely run out.

Kenya expected 136,000 doses by the end of 2026, the report said.

Where it is offered in Kenya, and what it costs

Lenacapavir is offered free of charge at selected public health facilities in 15 counties, according to the WHO's Kenya office.

The counties are Busia, Homa Bay, Kajiado, Kakamega, Kiambu, Kilifi, Kisii, Kisumu, Machakos, Migori, Mombasa, Nairobi, Nakuru, Siaya and Uasin Gishu.

The programme began on 26 February 2026, following the arrival of the first 21,000 starter doses on 17 February with support from the Global Fund.

The national rollout is planned in three phases: the first 15 counties, followed by another 15 and then the remaining 17, with the aim of eventually covering all 47 counties.

By late August, preparations for a limited second phase were under way, with health worker training taking place.

The clinic visit, step by step

Before receiving lenacapavir, a person must undergo an HIV test to confirm they do not have the virus.

The initial dosing schedule includes injections under the skin and oral tablets during the first two days.

This is followed by another injection every six months.

According to Gilead's prescribing information, each injection visit involves two injections under the skin.

The initial dose also includes oral tablets on the first and second days.

People must return for their subsequent injections on schedule and undergo HIV testing before each dose.

Timing matters because missing scheduled injections can leave people without adequate protection and increase the risk of acquiring HIV.

If infection occurs while medicine remains in the body at insufficient levels, there is also a risk of drug resistance.

NASCOP instructed counties to trace everyone due for a second injection and ensure they received it within two weeks of the scheduled date.

By late August, NASCOP said about 15,800 doses had been administered across the 15 counties, reflecting strong demand.

Side effects reported so far

The most frequently reported side effects in PURPOSE 5 involved the area where the injection was given.

These included lumps at the injection site (67.8%), pain (60.0%), hardened skin (20.6%) and redness (17.8%).

Gilead reported that these reactions were mild or moderate.

The prescribing information also lists headache and nausea among common side effects reported in earlier trials.

Serious adverse events occurred in 3.9% of participants receiving lenacapavir and 3.4% of those receiving daily tablets.

Investigators determined that none of these events was related to the study medicines.

No participant in the injection group discontinued treatment because of adverse events.

Another important consideration is that lenacapavir remains in the body for a long time.

Gilead's safety information says traces of the medicine can remain for 12 months or longer after the last injection.

This means stopping the injections does not immediately remove the medicine from the body.

People who discontinue prevention need medical advice about alternative protection and follow-up.

When stock runs short

The shortage in Kenya highlights the importance of maintaining reliable supplies of a medicine that requires repeat injections every six months.

People who have already started lenacapavir need to receive their subsequent doses on schedule to maintain protection.

At the same time, new clients need access to prevention services.

Maria Mulwa, the AIDS and STI coordinator for Kilifi County, said health workers there were encouraging people to consider other prevention options while supplies remained limited, including daily PrEP tablets and the long-acting injection cabotegravir.

The 4,600 continuation doses NASCOP sent to counties were reserved for people already receiving lenacapavir, rather than for starting new clients.

Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition (AVAC), said in an earlier interview that whether lenacapavir helps reduce new HIV infections in Kenya will depend on access, delivery and demand.

For now, the PURPOSE 5 trial shows that substantially more people remained on twice-yearly lenacapavir than daily tablets during the one-year study in the UK and France.

Across Africa, more than 125,000 people have already started the injection.

In Kenya, however, the supply shortage highlights a major question facing the rollout: whether health systems can maintain enough stock to meet demand and ensure that people who start the medicine can continue receiving it on schedule.