Thursday 7 March 2019

HIV infections lowered by 30% in universal testing and treatment study

Communities in southern Africa which received a door-to-door HIV testing intervention and support for linkage to care had substantially lower HIV incidence, a study presented to the Conference on Retroviruses and Opportunistic Infections (CROI 2019) has shown.

The PopART study measured the impact on HIV incidence of home-based HIV testing and linkage to care, combined with antiretroviral treatment delivered through health services. It is the largest HIV prevention trial ever done, with around one million people living in the 21 urban communities in Zambia and South Africa where it was conducted.

During the study, community health workers systematically visited all households within a geographical area and offered home-based HIV testing and counselling. Individuals testing HIV positive were referred to clinics for HIV treatment.

The community health workers returned to households throughout the year to follow up on referrals and to offer HIV testing to household members who were absent at previous visits or who had declined testing. Professor Richard Hayes, presenting the study results, emphasised that this was a trial of universal testing, linkage to care and treatment – not just of universal treatment.

Compared to the communities receiving routine health services, the communities receiving door-to-door testing and support, with HIV treatment started as per national guidelines, had a 30% lower incidence of HIV.

Some of the study’s results were less clear-cut. A third group, which also received testing, support and HIV treatment, had only a 7% reduction in incidence. The research group is now exploring this in more detail.

“The overall evidence for the effectiveness of the intervention is strong,” Hayes said. “Community-based services for universal HIV testing and linkage to care are a key component of combination prevention in the global effort to achieve effective HIV control.”

Hepatitis C drops among HIV-positive MSM in London

New cases of hepatitis C virus (HCV) among HIV-positive men who have sex with men (MSM) seen at three clinics in London have declined by nearly 70% since 2015, according to a presentation at CROI 2019.

Presenter Dr Lucy Garvey said the decline is largely attributable to regular HCV screening and a treatment-as-prevention effect resulting from wider use of direct-acting antiviral (DAA) therapy. The research team looked at trends in the incidence of acute HCV infection among HIV-positive MSM between July 2013 and June 2018.

This retrospective study included around 6000 HIV-positive men at risk for hepatitis C seen at three central London clinics. The rate of new HCV infections peaked in 2015, at 17 cases per 1000 person-years. After that, the rates declined steeply and steadily, falling to six total new infections and three first infections per 1000 person-years in 2018. From 2013 to 2016, patients started HCV therapy an average of 23 months after diagnosis. From 2016 onward, a majority were treated in clinical trials, waiting an average of 10 months.

However, another study presented at the conference cast doubt on whether it is possible to treat our way out of the HCV epidemic. The New York study found that gay and bisexual men who are cured of hepatitis C are becoming re-infected at a rate seven times higher than the initial infection rate.

Descovy is non-inferior to Truvada for daily PrEP

A daily pill containing the newer formulation of tenofovir in combination with emtricitabine (Descovy) had a comparable protective effect to the existing daily pill which contains the older tenofovir and emtricitabine (Truvada), the conference heard.

The only licensed medication for oral pre-exposure prophylaxis (PrEP) is a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine, marketed by Gilead Sciences as Truvada, but also available in many countries as a generic product. TDF works well and has few side-effects, but is associated with kidney and bone problems in some people.

Gilead has developed a new formulation, tenofovir alafenamide (TAF), which has a lower risk of bone and kidney problems. Because it is a new product, it is under patent and not available as a generic product. TAF is included in several combination pills used for antiretroviral therapy, including Descovy. These have been tested for use as HIV treatment, but had not previously been tested for use in PrEP.

Dr Brad Hare presented the results of the DISCOVER study, a randomised controlled trial to evaluate the efficacy and safety of TAF/emtricitabine for PrEP among men who have sex with men and transgender women at risk of HIV infection.

The 5387 participants were recruited between September 2016 and May 2017 in eleven countries in North America and Europe. Participants were randomised to receive either daily TAF/emtricitabine or TDF/emtricitabine.

When the study ended in January 2019, there had been 22 HIV infections. Fifteen cases appear to be due to low or minimal adherence. Five were probably due to an infection that had been acquired just before entering the study. Two men acquired HIV despite “adequate” drug levels, one in each arm of the study.

There were fewer infections on TAF than on TDF, but the difference was not statistically significant – this means that TAF was demonstrated to be “non-inferior” to TDF in preventing HIV infection, but not superior to it. As expected, the newer formulation had better bone and kidney safety outcomes, although the small changes in bone and kidney biomarkers observed in the study may not be clinically significant.

Sudden cardiac death is more common in people with HIV

Two studies presented at CROI 2019 investigated the incidence of sudden cardiac death in people with HIV. Researchers found that deaths caused by sudden cardiac arrest are significantly more common in people with HIV than the general population and were more likely to be associated with overdose or kidney failure in people with HIV, as well as low CD4 count or detectable viral load.

Sudden cardiac death occurs when there is an electrical malfunction in the heart, after a disturbance in the heartbeat rhythm (arrhythmia). Arrhythmia can be caused by heart disease, heart failure, trauma or overdose. Sudden cardiac arrest can be treated with a defibrillator, to shock the heart back into rhythm, or the use of cardiopulmonary resuscitation (CPR).

One group of researchers looked at sudden cardiac deaths which occurred outside of hospital settings in San Francisco County between 2011 and 2016. They identified 47 cases in people with HIV and 505 in HIV-negative people and compared the two groups. The HIV-positive group were significantly younger, and more likely to have a previous history of heart attack, to have a psychiatric diagnosis, current substance, alcohol and tobacco use.

Autopsies identified cases of ‘occult overdose’ – where no drug use was obvious until an autopsy was carried out. Just over a third of deaths in the HIV-positive group were due to occult overdose, compared to 13% in HIV-negative people. Kidney failure was also a more common cause in the HIV-positive group (6% vs 1%).

The second study looked at sudden cardiac death in US military veterans between 2003 and 2014. In the study group of 144,362 veterans, 43,413 had HIV, almost all were male and the mean age was 50.

There were 777 cases of sudden cardiac death in the group with HIV and the researchers calculated that the risk of sudden cardiac death was 15% higher for people with HIV, but only when they had a low CD4 count (below 200) or a detectable viral load.

In both groups, well known lifestyle factors such as smoking increased the risk, as did underlying health problems such as heart disease, hepatitis C, and chronic pulmonary disease.

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