Six-monthly injectable PrEP is 89% more effective than oral PrEP in gay and bisexual men and trans people

The full results of the PURPOSE 2 study, which compared the efficacy of six-monthly injections of the long-lasting drug lenacapavir with daily pills of tenofovir disoproxil / emtricitabine (TDF/FTC, also known as Truvada) were reported to HIV Glasgow by Dr Onyema Ogbuagu of Yale School of Medicine. The trial enrolled a diverse group of gay and bisexual men, trans women and men and non-binary people in four continents.

There were nine HIV diagnoses in 1088 people receiving TDF/FTC and only two in 2183 people receiving lenacapavir. This equates to an annual HIV incidence of 0.93% in TDF/FTC recipients versus 0.10% in lenacapavir recipients, meaning that lenacapavir was 89% more effective than TDF/FTC at preventing HIV acquisition. The efficacy of each PrEP product was also compared with background HIV incidence, showing that lenacapavir prevented 95.8% of infections that would likely have occurred without PrEP, while TDF/FTC prevented 60.8%. While over 90% of injections were taken on time, adherence to daily pills declined during the study.

Gilead Sciences plans to seek regulatory approval for lenacapavir PrEP by the end of the year.

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Once-weekly combination of islatravir and lenacapavir safe and effective in 48-week study

A once-weekly oral combination of two investigational antiretrovirals, islatravir and lenacapavir, maintained high rates of viral suppression 48 weeks after a switch from daily treatment, the congress heard. If further data continue to show promise, this could be the first once-weekly oral HIV treatment.

Dr Amy Colson of Community Research Initiative, Boston, presented results of a phase 2b trial that randomised 104 virologically suppressed adults on bictegravir / emtricitabine / tenofovir alafenamide (B/F/TAF) to switch to once-weekly lenacapavir (300mg) and islatravir (2mg) tablets or to continue taking B/F/TAF.

By intent-to-treat analysis, 94% assigned to islatravir / lenacapavir and 92% assigned to B/F/TAF had viral load below 50 copies/ml at week 48. All participants on study treatment at week 48 had viral load below 50 copies/ml.

Changes in CD4 cell counts or total lymphocyte counts (a concern when islatravir is used at higher doses) did not differ significantly between the two groups.

Two phase 3 studies of the combination in virologically suppressed people are underway.

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The long-acting HIV treatment era is just beginning

The pipeline for HIV treatment is increasingly dominated by long-acting antiretrovirals, Professor José Arribas of La Paz Hospital, Madrid, told HIV Glasgow. Development is focusing on prolonging drug activity, increasing the interval between doses and reducing the burden of adherence.

“If you ask a person with HIV, [on] how many days will I have to worry about taking my medication in the next six months? If you are taking daily pills, the answer is 181 days, if you are taking pills every week, you have to worry on 26 days. If you are taking drugs every four months, you worry two days,” Arribas said.

Once-weekly oral regimens that are in development combine islatravir either with lenacapavir (as described above) or with the new NNRTI ulonivirine (formerly known as MK-8507). Gilead is also working on three other agents for once-weekly dosing.

Numerous long-acting capsid inhibitors, integrase inhibitors and broadly neutralising antibodies are in development. These may allow dosing every two, three, four, or six months, but most studies are at an early phase.

However, the pipeline faces a major reality check: the end of the last patents on dolutegravir by 2029. This means that the price of the world’s most-used antiretroviral combination, tenofovir disoproxil, lamivudine and dolutegravir (TLD) will fall to around €50 a year. Strong data will be needed to convince funders that long-acting treatments deliver benefits worth paying for, Arribas predicted.

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Statins and lifestyle changes recommended for more people living with HIV by European experts

The European AIDS Clinical Society (EACS) has recommended that everyone with HIV with a 5% or higher risk of a heart attack or stroke in the next 10 years should receive a moderate-intensity statin, and those with a 10% or higher risk should receive a high-intensity statin.

For people with HIV under the age of 50, the thresholds are lower, at 2.5% and 7.5% respectively.
The recommendations have been made in light of the REPRIEVE study, which found that treatment with pitavastatin reduced the risk of a major cardiovascular event by 35% in people with HIV who had low-to-moderate cardiovascular risk over five years of follow-up.

EACS guidelines on preventing cardiovascular disease also recommend support to stop smoking, and advice on diet and lifestyle.

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One in nine gay and bisexual men using PrEP in Europe gets it through informal channels

A large European survey of gay and bisexual men using PrEP has found that while 89% are accessing it through their country’s official healthcare system, 11% are still getting it using informal means such as online purchase, from friends or from drug dealers.

Men acquiring PrEP informally were younger than other PrEP users, more likely to be unemployed or a student, more likely to be having financial difficulties, and more likely to be a migrant. They were also more likely to have suboptimal adherence or to discontinue PrEP altogether.

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23% of people with HIV in the UK have depression or anxiety, but rates are much higher in some groups

Strong evidence of the links between mental health and socioeconomic disadvantage, lack of social support and stigma emerge from a large, representative sample of people attending HIV clinics in the United Kingdom. While 21% of people with HIV had symptoms of depression, this rose to 37% of people who felt ashamed of their HIV status and 50% of those who did not have enough money for basic needs, Dr Fiona Lampe told HIV Glasgow.

Mental health symptoms were also more common in people who were unemployed, people with less secure housing, and people with co-morbidities in addition to HIV.
Around half of those with symptoms of depression or anxiety weren’t receiving any treatment for it. Only 38% of Black African heterosexual men with symptoms were receiving treatment, compared to 74% of gay, bisexual and other men who have sex with men.

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HIV status does not affect liver transplant outcomes, 15-year Spanish study finds

People with HIV who received liver transplants in Spain were just as likely to survive and not experience organ rejection as people without HIV during a 15-year follow-up period, the congress was told.

Professor Jose Miro and colleagues at the University of Barcelona Hospital Clinic carried out a retrospective case-control study in which they followed 24 people with HIV who received liver transplants between 2003 and 2012 and matched each patient with three HIV-negative liver transplant recipients. At the time of the transplant, all recipients had viral hepatitis, 85% had detectable hepatitis C and 28% had hepatocellular carcinoma.

Miro said that the findings, the first European study on long-term outcomes after liver transplantation in people with HIV, support the use of liver transplants for people with HIV wherever they are clinically indicated.

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Integrase inhibitor resistance after treatment failure more common in treatment-experienced people

The first data from a global registry of people who experienced failure of an antiretroviral regimen containing bictegravir, cabotegravir or dolutegravir show that just over one in four had major resistance mutations associated with resistance to at least one integrase inhibitor. Resistance was most likely to develop in people who had taken previous antiretroviral regimens, especially the first-generation integrase inhibitors raltegravir or elvitegravir.

HIV Glasgow heard that although the failure rate of integrase inhibitor-based treatment is remarkably low, there is considerable uncertainty about how often drug resistance emerges in these circumstances. Globally, four people with HIV in every five receive treatment with an integrase inhibitor (predominantly dolutegravir) but most people are in countries with limited or non-existent surveillance of drug resistance.

But Dr Andrew Hill of Liverpool University cautioned against jumping to conclusions about the clinical implications of resistance mutations. “We are still at an exploratory phase in knowing which mutations will lead to someone never being able to take dolutegravir or bictegravir again, and which mutations we could treat through and get people resuppressed on,” he told the conference.

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Second woman possibly cured of HIV

The first report of a possible new cure of HIV in someone who received a stem cell transplant for leukaemia was shown as a poster at the congress. The patient has maintained an undetectable viral load for a year since stopping all antiretroviral therapy in October 2023.

Although the case does have some puzzling aspects, if her HIV viral load continues to be undetectable, she will be the second woman and the seventh person to be cured of HIV by means of a transplant.

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Novel antibody-based regime keeps HIV at bay for six months

A long-lasting combination therapy regimen designed to be taken every six months kept HIV suppressed in 26 out of 32 people who changed from daily oral therapy. The regimen consisted of one infusion of each of Gilead’s two broadly neutralising antibodies teropavimab and zinlirvimab, plus a subcutaneous injection of their capsid inhibitor lenacapavir.

Three people withdrew from the study before it ended, while another three developed a detectable viral load (over 20 copies) on the lower dose of zinlirvimab. However, all 15 people who stayed on the higher dose maintained viral suppression for six months without taking further anti-HIV medication. The higher dose of zinlirvimab is being taken forward in a phase 2 trial.

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