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Tuesday 24 July 2018

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Zero transmissions mean zero risk – for gay men as well as heterosexuals

Alison Rodger at the PARTNER 2 press conference. Photo by Gus Cairns.

The likelihood of anyone living with HIV who has an undetectable viral load passing the virus on to a sexual partner is scientifically equivalent to zero, researchers confirmed at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam today.

Final results from the PARTNER study were presented this morning at a press conference. Results originally announced in 2014 from the first phase, PARTNER 1, already indicated that ‘Undetectable = Untransmittable’ (U=U). However, the statistical certainty of this result was not quite as convincing in the case of gay men, or for anal sex, as it was for vaginal sex.

Results from PARTNER 2, the second phase, which only recruited gay couples, were presented today. The results indicate, in the words of the researchers, “A precise rate of within-couple transmission of zero” for gay men as well as for heterosexuals.

The PARTNER study recruited HIV serodiscordant couples (one partner living with HIV, one partner HIV negative) in 14 European countries. The study found no transmissions between gay couples where the partner living with HIV had a viral load under 200 copies/ml – even though there were nearly 77,000 acts of condomless sex between them.

PARTNER 2 tells us that U=U holds just as strongly for gay men (and for anal sex) as for heterosexuals.

The ‘Undetectable = Untransmittable’ message goes global

Slide from John Blandford's presentation on Vietnam's K=K campaign

In Guatemala, the slogan is ‘Indetectable = Intransmisible’ (I=I); in the Netherlands, it’s ‘Niet meetbaar = Niet overdraagbaar’ (N=N); and in Turkey, ‘Belirlenemeyen = Bulaştırmayan’ (B=B). One of the most striking aspects of Sunday’s pre-conference on ‘Undetectable = Untransmittable’ (U=U) was the extent to which the campaign has energised advocates around the world.

This year is the tenth anniversary of the Swiss Statement, which was the first published document to say that, under defined circumstances, people living with HIV who have fully suppressed viral loads due to treatment cannot transmit HIV.

Anthony Fauci, probably the most senior HIV research scientist in the US, reviewed the evidence that underpins U=U. Since the mid-1990s, data showing the inverse relationship between the level of virus and the rate of HIV transmission have been accumulating. The introduction of combination therapy “was the definitive moment of U=U and we didn’t even realise it then,” he said.

However, in many low- and middle-income countries, viral load monitoring is not routinely available, making it impossible for an individual to be confident that they have an undetectable viral load. U=U provides an additional argument for increasing access to viral load monitoring.

One remaining area of scientific uncertainty concerns breastfeeding. Linda-Gail Bekker of the Desmond Tutu HIV Centre in South Africa said that there are still gaps in the data, but there is clearly a strong relationship between viral load and the potential for transmission during breastfeeding.

Dolutegravir-based ART recommended for all – if reliable contraception is available

Women at the dolutegravir demonstration at AIDS 2018. ©International AIDS Society/Marten van Dijl

The World Health Organization (WHO) has issued new antiretroviral treatment guidelines recommending dolutegravir-based treatment as the preferred option for all adults, adolescents and children, including women and adolescent girls who have access to consistent and reliable contraception.

Speakers at the AIDS 2018 conference said the decision highlights the huge gap in access to reliable contraception and its lack of integration into HIV programmes, especially in sub-Saharan Africa, where access to sexual and reproductive health services is emerging as a major challenge facing HIV treatment programmes.

The guidelines were released on the opening day of the conference, where women living with HIV from sub-Saharan Africa demonstrated to demand that they, not ministries of health, should decide whether they receive dolutegravir. The protest came in response to recent decisions in some countries to withhold dolutegravir from women of childbearing potential due to safety concerns over the use of the drug in the early stages of pregnancy.

Ministries of Health and women living with HIV need to balance the risk of neural tube defects – which are reduced by folic acid supplementation – if dolutegravir is used against the greater risk of unsuppressed viral load, side-effects or adverse birth outcomes other than neural tube defects if efavirenz or another antiretroviral drug is used in place of dolutegravir, speakers agreed.

Countries also need to consider the balance of risk and benefits at a population level, said Meg Doherty of WHO. These include fertility levels, contraceptive availability and coverage, levels of antiretroviral drug resistance and drug availability.

People taking dolutegravir in Brazil more likely to have suppressed viral load

Slide from Mariana Veloso Meireles’s presentation at AIDS 2018.

People receiving dolutegravir-based antiretroviral treatment in Brazil’s national treatment programme were far more likely to have a fully suppressed viral load six months after starting treatment, according to a review of all patients who started treatment between 2014 and 2017.

Brazil was one of the first middle-income countries to adopt dolutegravir-based treatment as the preferred option for first-line therapy, in early 2017. Dolutegravir is an integrase inhibitor with a high barrier to resistance.

To assess the efficacy of dolutegravir relative to other drugs used in first-line treatment, Brazil’s Ministry of Health carried out an analysis of viral suppression six months after starting treatment in 103,240 people who began treatment between January 2014 and July 2017.

Viral suppression rates six months after starting treatment ranged from 63.7% in those who started treatment on the regimen of tenofovir, lamivudine and lopinavir/ritonavir (2% of the cohort) to 85.2% in those who started treatment with tenofovir, lamivudine and dolutegravir (7.2%).

An analysis controlling for other factors found that people who received dolutegravir with tenofovir and lamivudine were 42% more likely to have an undetectable viral load (< 50 copies/ml) six months after starting treatment than people receiving efavirenz with tenofovir and lamivudine.

The findings lend further support to the World Health Organization’s recommendation that dolutegravir-based treatment should be the preferred first-line regimen for adults and adolescents starting antiretroviral treatment.

On-demand dosing as effective as daily dosing in first year of French PrEP study

Jean-Michel Molina at the Prévenir press conference. Photo by Roger Pebody.

There have been no new HIV infections in a demonstration study of PrEP (pre-exposure prophylaxis) in France. Over half of participants chose to use on-demand dosing for PrEP, with the rest opting for daily dosing, but both options have been equally effective, Jean-Michel Molina of the University of Paris Diderot told a press conference in Amsterdam today.

The ‘Prévenir’ (prevent) study is gathering data on the best ways to deliver PrEP in Île-de-France, which is the region of Paris and its suburbs. The researchers hope to show that having an extra 3000 people take PrEP will result in a marked fall in HIV diagnoses among men who have sex with men in the region.

Molina presented data on the first year (from May 2017) of the three-year study. A total of 1628 people have enrolled, almost all of whom (98.8%) are men who have sex with men. Twelve heterosexual men and women as well as eight transgender people have enrolled.

Participants can choose whether to follow the on-demand dosing schedule (sometimes referred to as ‘event-driven’ or ‘event-based’ dosing) that was validated in the IPERGAY study, or to use daily dosing, which is more commonly used in other parts of the world. On-demand dosing involves taking a double dose of PrEP (two pills) from 2-24 hours before anticipated sex, and then, if sex happens, additional pills 24 hours and 48 hours after the double dose.

There have been zero infections in both groups. The researchers estimate that, so far, 85 HIV infections have been avoided in this cohort of 1628 people.

Scientific analysis from Clinical Care Options

Clinical Care Options (CCO) is an official online provider of scientific analysis for the conference.

Their coverage will include capsule summaries of important clinical data, downloadable slides and expert faculty commentary on key HIV prevention and treatment studies.

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