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Wednesday 25 July 2018

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Criminalisation of HIV high on agenda

Speakers at the Beyond Blame symposium. Image credit: @KatSmithson

Strategies to oppose the unscientific criminalisation of HIV transmission received a high profile at events held in Amsterdam this week to coincide with the 22nd International AIDS Conference (AIDS 2018).

These included the launch by the Global Commission on HIV and the Law of a Supplement to its 2012 report, Risks, Rights & Health.

The first edition of Risks, Rights & Health called on governments to outlaw discrimination, repeal punitive laws, and enact protective legislation to promote public health and human rights.

The 2018 Supplement emphasises that the original recommendations remain relevant, but offers additional recommendations, taking into account developments in science, technology, law, geopolitics and funding since 2012. 

The new recommendations include:

  • In countries where HIV criminalisation laws still exist, courts must require proof, to the applicable criminal law standard, of intent to transmit HIV.
  • Governments must ensure that, where an HIV-specific law has been repealed, there is a restriction on the application of any general laws to the same effect either for HIV or tuberculosis.
  • Governments must prohibit the prosecution under HIV-specific statutes, drug laws, or child abuse and neglect laws, of women living with HIV for choices they make during and after pregnancy, including about breastfeeding children.
  • Whenever HIV arises in the context of a criminal case, police, lawyers, judges and where applicable, juries, must be informed by the best available scientific evidence concerning the benefits and consequences of appropriate therapy.

Also this week, the Beyond Blame: Challenging HIV Criminalisation symposium, organised by HIV Justice Worldwide, brought together activists, advocates, lawyers, scientists, healthcare professionals, and policymakers from across the world to identify ways in which punitive laws and their enforcement might best be challenged.

The symposium included a comprehensive round up of the current state of criminalisation in regions across the world, personal testimonies of encounters with criminalisation and discussion of the benefits and pitfalls of using advances in prevention and treatment in advocacy work. Videos of the plenary sessions are available on the HIV Justice Worldwide YouTube channel.

Dolutegravir: update on neural tube defects from Botswana study

Rebecca Zash at AIDS 2018. Photo by Liz Highleyman.

A study of women living with HIV in Botswana has shown that taking dolutegravir (Tivicay, also in Triumeq and Juluca) when a baby is conceived is associated with a higher risk of neural tube defects in infants exposed to the drug when compared to efavirenz.

The findings were initially released in May and led to safety warnings by the European Medicines Agency and the US Food and Drug Administration. They warned that women who could become pregnant should not use dolutegravir without effective contraception. Subsequent World Health Organization (WHO) treatment guidelines, released yesterday, stress the importance of consistent and reliable contraception if women of childbearing potential opt to take the drug.

Further details were presented at AIDS 2018. The study looked at birth outcomes in women taking antiretroviral therapy at the time of conception and during pregnancy in Botswana between August 2014 and May 2018. A new analysis in 2018 looked at women who started dolutegravir-based treatment or another antiretroviral regimen prior to conception. This analysis looked specifically at neural tube defects. A neural tube defect occurs when the spinal cord, brain, and related structures do not form properly. The neural tube develops between 2 and 8 weeks of pregnancy and the most common cause of defects is lack of folic acid, but defects can also be caused by some medications.

The prevalence of neural tube defects was higher in infants born to women taking dolutegravir at the time of conception (0.94%) compared to women taking efavirenz or other antiretroviral drug regimens at conception (0.12%).

The news of a potential safety problem and the subsequent guidance from regulatory agencies and WHO has caused some ministries of health in lower- and middle-income countries to pause their plans to implement dolutegravir-based treatment as the preferred first-line treatment.

However, a modelling study presented by Caitlin Dugdale of Massachusetts General Hospital showed that avoiding the use of dolutegravir in women of childbearing age carries risks for women, children and their partners that might outweigh the risk of neural tube defects.

Assuming dolutegravir is more effective than efavirenz in suppressing viral load, dolutegravir would save 28,400 more lives than efavirenz, prevent 52,800 more cases of sexual transmission and prevent 5000 more infant infections than efavirenz, the model found.

The findings highlight the trade-offs inherent in making decisions about the most appropriate first-line regimen, especially in countries with large treatment programmes and high fertility rates. But, as Susan Little of Georgetown University commented, “Policy may not be the right locus for determining acceptable trade-offs in this case; policy may be about supporting meaningful choice for women."

PrEP does not lower feminising hormone level in trans women

Akarin Hiransuthikul and Mackenzie Cottrell at AIDS 2018. Photo by Liz Highleyman.

Using Truvada (tenofovir DF/emtricitabine) for HIV prevention does not lower levels of feminising hormones, offering reassurance for trans women who are concerned about drug interactions.

Some prior studies have shown that blood concentrations of PrEP (pre-exposure prophylaxis) drugs in trans women were lower than expected. A previous study found that some trans women living with HIV are hesitant to use antiretroviral therapy or do not take it as prescribed because of concerns about drug interactions with their hormone therapy. The same may be true of PrEP.

The iFACT study, presented at the conference, enrolled 20 HIV-negative trans women who still had intact testicles and had not received injectable hormones within the past 6 months. The participants started a feminising hormone therapy regimen of estradiol valerate (2 mg/day), plus the androgen blocker cyproterone acetate (25 mg/day).

At week 3, the women started taking Truvada. At week 5, they stopped the hormone regimen so the researchers could compare PrEP drug levels on and off hormones, resuming at week 8. They then continued on both hormones and PrEP through week 15.

The study showed that concurrent use of hormone therapy and PrEP did not affect hormone levels. However, tenofovir levels in the blood were reduced by 13% in the presence of estradiol but remained above the level shown to confer protection from HIV infection.

A small related study found reduced levels of the active form of tenofovir in the rectal tissue of trans women taking feminising hormone therapy. Levels of tenofovir in blood were unaffected, but in rectal tissue tenofovir levels decreased as estradiol levels increased. The researchers conclude that estradiol may impact PrEP efficacy. Presenter Mackenzie Cottrell said that until more data are available, "It's fair to share with trans women that there are still uncertainties and it might be better to take [PrEP] daily."

Rapid start to HIV treatment linked to falls in diagnoses

Alison Hughes from the San Francisco Department of Public Health at AIDS 2018. Image credit: @martinxholt

More rapid initiation of HIV treatment after diagnosis – and the shortening of the period with detectable viral load – has coincided with declines in new HIV diagnoses in San Francisco and Melbourne, research groups reported at the conference.

In theory, reducing the period during which people have a detectable viral load should reduce the period during which people can pass on HIV to partners and so reduce the number of new HIV diagnoses. In San Francisco and Melbourne, rapid treatment initiation is now the norm.

In Melbourne, 292 gay and bisexual men were diagnosed with HIV between 2012 and 2017 and the percentage with undetectable viral loads within 12 months of diagnosis increased from 59% to 97%.

New HIV diagnoses began to decline sharply after 2014, corresponding with a decline in the interval between diagnosis and undetectable viral load from 98 days to 49 days between 2014 and 2016. HIV incidence declined from 0.86% in 2014 to 0.38% in 2016 and 0.27% in 2017.

The San Francisco City Department of Public Health looked at people diagnosed since 2008 and how much time they spent with a viral load above 1500 copies/ml in the year after diagnosis (the level above which HIV transmission is thought to become more likely).

A total of 2256 people were diagnosed with HIV between 2008 and 2016. In 2008, people diagnosed with HIV spent 46% of the first year after diagnosis with a viral load above 10,000 copies/ml and 62.3% with a viral load above 1500 copies/ml.

In 2010, a policy of offering treatment immediately after diagnosis was introduced.

By 2016, people diagnosed spent only 17% of the first year after diagnosis with a viral load above 10,000 copies/ml and 24.8% with a viral load above 1500 copies/ml.

High rate of hepatitis C infection in Amsterdam PrEP programme

Elske Hoornenborg at AIDS 2018. Photo by Liz Highleyman.

Regular hepatitis C testing among the HIV-negative gay men and other men who have sex with men (MSM) participating in the Amsterdam PrEP demonstration project (AmPrEP) has revealed high rates of hepatitis C infection passed on through sex. The rate of re-infection in men already treated for hepatitis C was even higher.

AmPrEP started in August 2015 and will continue to December 2020. The project has recruited 374 MSM and two trans women and offers them a choice of daily or event-driven HIV pre-exposure prophylaxis (PrEP).

Participants are tested for hepatitis C every six months. There was already a quite high prevalence rate of 4.8% for hepatitis C when people joined the project.

There were 12 new hepatitis C infections diagnosed up to December 2017. This indicates an annual incidence of about 1%. This is quite typical of rates of sexual hepatitis C infection among HIV-positive gay men – but it hasn’t been seen in HIV-negative gay men before.

Of the 12 hepatitis C infections, six affected men had been previously cured of hepatitis C. The annual incidence rate for re-infection was an extraordinarily high 25.5% a year.

AmPrEP principal investigator Elske Hoornenborg commented that sexual health information and encouragement to avoid behaviours that may spread hepatitis C were important but that frequent testing and immediate hepatitis C treatment were probably the only way to start bringing down the rates of circulating hepatitis C in the gay community.

Dolutegravir dual therapy works well for first-time HIV treatment

Pedro Cahn and Linda-Gail Bekker at AIDS 2018. Photo by Liz Highleyman.

A two-drug combination of dolutegravir (Tivicay) and lamivudine suppressed viral load as well as a standard three-drug antiretroviral regimen for people with HIV starting treatment for the first time, according to results from a pair of studies (GEMINI 1 and 2).

Previous studies have shown that dolutegravir plus lamivudine maintains viral suppression in people who switch from a triple regimen with an undetectable viral load. A combination pill containing dolutegravir and rilpivirine (Juluca) was recently approved in Europe and the US, but only as an option for changing treatment for people with a suppressed viral load.

Together, the two GEMINI studies enrolled 1433 participants. About 85% were men, two-thirds were white and the median age was approximately 32 years. At baseline, 80% had viral loads < 100,000 copies/ml while 20% had high viral loads between 100,000 and 500,000 copies/ml. Most had CD4 cell counts above 200.

Participants in the study received either dolutegravir and lamivudine (dual therapy) or dolutegravir plus tenofovir DF and emtricitabine (triple therapy). The study looked at the proportion of people with a viral load below 50 copies/ml, 48 weeks after starting treatment.

Response rates were high, with more than 90% of participants having an undetectable viral load with both regimens, showing that the dual regimen was non-inferior to standard therapy. However, among the minority of people with low CD4 counts, the triple regimen appeared to work better (79% vs 93%).

The dual regimen led to fewer side-effects including kidney and bone problems.

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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