NAM AIDS MAP – 9TH IAS CONFERENCE 2017 PARIS FRANCE

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Tuesday 25 July 2017

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International study of gay couples reports no transmissions from an HIV-positive partner on treatment

Image from Opposites Attract study: www.oppositesattract.net.au

A study of 343 gay couples, where one partner had HIV and the other did not, has not found a single case of HIV transmission in 16,889 acts of condomless anal sex, the 9th International AIDS Society Conference on HIV Science (IAS 2017) was told today.

The Opposites Attract study looked at whether HIV is transmitted between gay male couples of different HIV status when the HIV-positive partner is on treatment that fully suppresses HIV. The HIV-positive partners in Opposites Attract had an undetectable viral load 98% of the time.

The study recruited and followed-up gay couples at clinics in Australia, in Bangkok and in Rio de Janeiro.

The evidence from Opposites Attract adds to the evidence from the PARTNER study that people living with HIV who are on effective HIV treatment that fully suppresses their virus cannot pass on HIV through sex. Taken together, the two studies have not found a single case of HIV transmission in nearly 40,000 acts of condomless anal sex between gay men.

This adds further strength to the “U=U” (Undetectable equals Untransmittable) tagline of the Prevention Access Campaign, whose consensus statement has been signed by NAM and also by the International AIDS Society (IAS), organisers of this week’s Conference on HIV Science in Paris.

At a press conference on Monday about viral load and infectiousness, Dr Anthony Fauci, director of the US National Institute for Allergies and Infectious Diseases, said: “Scientists never like to use the word ‘Never’ of a possible risk.

“But I think in this case we can say that the risk of transmission from an HIV-positive person who takes treatment and has an undetectable viral load may be so low as to be unmeasurable, and that’s equivalent to saying they are uninfectious. It’s an unusual situation when the overwhelming evidence base in science allows us to be confident that what we are saying is fact.”

Child has controlled HIV despite being off therapy for 8.5 years

A nine-year-old in South Africa has well-controlled viral load despite being off HIV treatment for 8.5 years, the conference was told.

The child was a participant in the CHER study, which compared two treatment strategies for HIV-positive infants. Diagnosed with HIV when one-month old, the child started antiretroviral therapy (ART) one month later and was randomised to a group that received 40 weeks of ART.

Now aged 9.5 years, the child has maintained an undetectable viral load since stopping treatment; the number of cells containing HIV DNA – the viral reservoir – has also remained stable since treatment was stopped.

The child is able to mount an immune response to HIV. It’s possible that HIV may be present at extremely low levels, but no virus capable of replication has been detected using various testing techniques.

Researchers have been careful not to describe the child as cured and are still unclear why the viral load has remained undetectable for such a long period without therapy.

The child is the third example of an infant who began HIV treatment very soon after birth, stopped treatment after months or years and went on to control HIV infection for a prolonged period. One of these children maintains viral control eleven years after stopping treatment.

Experimental integrase inhibitor bictegravir does well in clinical trial

Joel Gallant presents new data on bictegravir at IAS 2017. Photo by Liz Highleyman, hivandhepatitis.com

A single-tablet combination containing the experimental integrase inhibitor bictegravir was as effective as two established HIV treatment combinations, according to studies presented at the conference. The studies involved people starting antiretroviral therapy for the first time.

The first study compared bictegravir to dolutegravir, both taken with emtricitabine/tenofovir alafenamide (TAF). The results of this phase 3 study updated data from previously presented phase 2 research.

At week 48, the bictegravir combination was shown to be non-inferior to the dolutegravir-containing regimen, with 89 and 93% of participants, respectively, having an undetectable viral load. Treatment discontinuations were slightly more common with bictegravir (3 vs 1%), but these were usually for reasons other than poor efficacy or tolerability. Virological failure was rare. Headache and diarrhoea were the most commonly reported side-effects.

A second study compared the same bictegravir combination to the Triumeq combination pill containing dolutegravir, abacavir and lamivudine.

At week 48, rates of viral suppression were comparable for the two combinations (92 vs 93%), demonstrating the non-inferiority of the experimental drug. Virological failure was rare with both regimens.

Several side-effect-related outcomes favoured the bictegravir combination.

Studies looking at the safety and efficacy of bictegravir in people switching treatment are fully enrolled; a study involving women will report in 2018 and research involving children and adolescents is underway.

Hepatitis C treatment feasible and effective in Africa

Karine Lacombe of Saint-Antoine Hospital, Paris, at IAS 2017. Photo by Liz Highleyman, hivandhepatitis.com

Treatment for hepatitis C virus (HCV) in Africa using direct-acting antivirals (DAAs) can produce cure rates as good as those seen in industrialised countries, data presented to the conference show.

The researchers believe these findings support the scale-up of HCV testing and treatment access in resource-limited settings.

Primary analysis of a study conducted in Cameroon and Ivory Coast were presented to delegates. The findings were highly encouraging.

People with genotypes 1 and 4 were treated with sofosbuvir/ledipasvir (Harvoni) for 12 weeks, while those with genotype 2 received sofosbuvir plus weight-based ribavirin.

A sustained virological response was observed in 89% of participants overall, with 78% of people with cirrhosis also attaining this outcome.

These cure rates compare to those observed in Europe and North America.

However, cost will be a major barrier to rolling out access to DAAs in resource-limited settings and advocacy is needed to ensure the availability of generic formulations. The assistance of international funders will also be needed.

Self-testing for HIV: gay men

Robin MacGowan at IAS 2017. Photo by Roger Pebody, aidsmap.com

Providing free self-testing kits increases the frequency with which gay men test for HIV and also increases HIV diagnosis rates, according to research presented to the conference.

Research conducted in the US enrolled over 2000 HIV-negative gay men and other men who have sex with men. They were randomised into intervention and control arms: men in the intervention arm received four self-testing kits through the post to be used over a 12-month period, whereas men in the control group didn’t receive anything.

Every three months, participants completed questionnaires asking about their HIV testing behaviour.

Men who received the free self-testing kits tested for HIV more frequently: 79% reported at least three tests during the study period, compared to 22% in the control group.

A total of 22 men in the intervention group were diagnosed with HIV, double the number seen in the control arm. Although men in the later group were more likely to be linked to HIV care than men given free self-tests, the difference was not statistically significant.

A pilot study conducted by the Terrence Higgins Trust, a UK-based HIV charity, showed that the distribution of free self-testing kits to gay men was feasible and acceptable.

Approximately 5000 tests were distributed during the six-week pilot and over two-thirds of those requesting the kits reported risky sexual behaviour.

Over 3000 men reported their test results via a secure webpage, with 28 (1%) of these individuals reporting a reporting a reactive result. Telephone contact was made with 22 of these men, all of whom had already sought a confirmatory test.

Self-testing for HIV: female sex workers

Sue Mavedzenge at IAS 2017. Photo by Roger Pebody, aidsmap.com

A series of presentations showed that self-testing is acceptable and feasible for sex workers in resource-limited settings.

Investigators reported on research conducted in Zimbabwe, Zambia, Uganda and Kenya.

HIV prevalence among female sex workers in Zimbabwe is as high as 50% but only two-thirds of sex workers are aware of their HIV status, with 43% taking antiretroviral therapy and only a third virally suppressed – well below the 90-90-90 target.

Self-testing was offered as an option to 600 women attending a specialist sexual health clinic for sex workers. Just over half – 54% – accepted. Testing wasn’t necessarily performed at home, indeed, most (96%) opted to use the testing kit in a dedicated room at the clinic. Just under a third had a reactive test, with 99% of those testing positive attending for a confirmatory test.

Follow-up questionnaires showed that all the women found the tests easy to use and trusted the result, and 98% said they were comfortable finding out the result with no one else there. Clinics were the preferred location for the distribution of the kits.

Randomised trials in Uganda and Zambia looked at the best way of distributing self-testing kits. Peer educators – all current or former sex workers – recruited other sex workers to the study. Participants were randomised into one of three study arms: direct distribution of testing kits; distribution of coupons which could be taken to a clinic or pharmacy for a kit; or standard of care, with the educator providing information on HIV testing services.

A thousand women were recruited in each country.

The study lasted four months and there were very high testing rates: 95-100% for direct distribution; 84-97% for coupon distribution and 87-89% for standard of care.

Linkage to care, however, was poorer among self-testers than those receiving the standard of care.

Research conducted in Kenya showed that text messages were a good way of promoting self-testing among female sex workers and male truckers.

Participants were sent reminders to test: those in the intervention arm were informed about the availability of self-testing, whereas individuals in the control arm were simply encouraged to test for HIV.

Among sex workers, 16% of those in the intervention arm compared to 6% in the control group tested for HIV, with 4% of truckers in the intervention arm also testing, compared to 1% in the control group.

Urgent action needed on treatment for cryptococcus

Sile Molloy at IAS 2017. Photo by Liz Highleyman, hivandhepatitis.com

Urgent action is needed to expand access to flucytosine, an antifungal drug used to treat cryptococcal meningitis in people living with HIV who have very advanced disease.

Results presented to the conference showed people treated with flucytosine had reduced mortality rates.

It’s estimated that 15% of HIV-related deaths (181,000) in low- and middle-income countries are caused by cryptococcal meningitis, and that 6% of people living with HIV who have a low CD4 cell count (below 100) are positive for the cryptococcal antigen.

The infection can be treated with a range of antifungal drugs: amphotericin B, fluconazole or flucytosine.

A two-week course of amphotericin B and flucytosine is the preferred therapy. Amphotericin B is administered by infusion in hospital. Access to flucytosine is severely limited in Africa.

Investigators compared several regimens that might be more feasible for use in sub-Saharan Africa in a randomised trial involving over 700 people recruited in four African countries between 2013 and 2016:

  • All oral: fluconazole plus flucytosine for 2 weeks.
  • One week: amphotericin B plus flucytosine, or fluconazole for seven days, followed by a further seven days of therapy with fluconazole.
  • Two week: amphotericin B plus flucytosine, or fluconazole for 14 days.

When used with amphotericin B, flucytosine was superior to fluconazole. One-week amphotericin B and flucytosine had the lowest ten-week mortality rate (24%).

Scientific analysis from Clinical Care Options

Clinical Care Options (CCO) is the official online provider of scientific analysis for delegates and journalists.

Over the next few weeks, their coverage will include capsule summaries of important clinical data, downloadable slidesets and expert webinars.

CCO and IAS present live CME/CE-certified webinars

Immediately at the end of the conference, leading experts will explore how the most recent data presented at IAS 2017 may affect your patient care strategies and will answer your questions.

  • Kathleen E Squires, MD: Wednesday 26 July, 9am Pacific, 12pm Eastern, 5pm UK, 6pm Central European
  • Anton L Pozniak, MD, FRCP: Thursday 27 July, 9am Pacific, 12pm Eastern, 5pm UK, 6pm Central European

Click here to register in advance (it’s free!) and submit your own questions.

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