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With HIV trends shifting, drugmakers look to boost diversity in research

Diversity was the main theme at an annual meeting of HIV researchers in Boston where participants presented trials for the latest medicines alongside studies showing race- and gender-related infection and treatment trends.

The Conference on Retroviruses and Opportunistic Infections, or CROI, is being held just a month after the most recent HIV drug approval was announced — for Gilead Sciences Inc.'s single-pill regimen Biktarvy.

While results of a late stage clinical trial showing Biktarvy worked as well as an older regimen garnered the most attention at the conference, nearly 90% of the trial participants were male and 73% white. An ongoing, women-specific study, also shared at the conference, showed Biktarvy was just as effective in that population.

This research has become vitally important as the HIV landscape changes.

While overall infection rates are falling and people are often living longer, transmissions are still climbing in certain subgroups, particularly in the U.S. population, according to data from the U.S. Centers for Disease Control and Prevention shared at the meeting.

This year, CROI presenters had to break up gender data where possible, Shema Tariq, attendee and clinical researcher on HIV and sexual health at University College London, noted in a tweet.

Drugmakers are responding

"When we look at trends as far as who is becoming infected with HIV, we see that there's a large upswing first in females, and we're starting to see that African-Americans or people of color are being infected at rates that far outweigh those from other groups," Kimberley Brown, medical director, HIV, at Janssen Pharmaceutical Cos., a unit of Johnson & Johnson.

J&J had filed an application seeking U.S. Food and Drug Administration approval for a single-tablet regimen of darunavir, combined with cobicistat, emtricitabine and tenofovir alafenamide, in September 2017. The single-tablet regimen is approved in Europe as Symtuza.

At CROI, the company presented analyses of its two late-stage darunavir trials — Amber and Emerald — that showed the darunavir tablet's effectiveness across gender, race, age and importantly, prior treatment backgrounds.

In Amber, which focused on patients who had not been treated for HIV previously, 11.7% of the 725 patients were women and 11.5% were African-American. Among Emerald's 1,141 patients, all of whom had been previously treated, 18% were women and 20.8% were African-American. Overall, 91% of darunavir patients saw the detectable levels of HIV in their blood go down, with similar response rates across groups.

Countering rising resistance

As people with HIV start to live longer, older patients and those with previous virologic failure — or building resistance to other medicines — have also become important groups to incorporate in research, Brown said.

"We all know that there's significant challenges that remain with the management of HIV," she said. "A lot of providers have told us that adherence and the risk of developing resistance is usually at the top of their minds when they are seeing a new patient."

J&J's Emerald study included people who had been on multiple HIV medicines known as antiretroviral therapies, as well as those with virologic failure — 27.3% of the trial participants had used more than seven antiretroviral therapies over their treatment history.

Darunavir reduced detectable levels of the virus in the blood of 94.9% of all patients, and was effective for 95.7% of those with previous virologic failure.

"With our study designs we had more of an inclusive, or real-world, patient population that providers may actually see in their clinics," Brown said.

Driving research

Diversity among researchers, particularly as new generations grow without the HIV crisis of years past, was also a key subject at the conference.

Of the 990 abstracts delivered at this year's CROI, 438 were by male presenting authors and 537 by female presenting authors, Judith Currier, CROI 2018 Chair and UCLA associate director of clinical AIDS research and education, said in her address to attendees.

More than 21 million people are on antiretroviral therapy globally, she continued, noting that infection rates were falling. But funding levels were also flat to declining at a key point in the disease's management, she said.

A growing youth population in sub-Saharan Africa, and the risk of infection among that population "is threatening the gains we've made in incidence," Currier said.

"Importantly, fewer young people are going into the field of HIV research — and this is a great concern, coupled with decreasing investment by industry and the lack of public perception that AIDS remains an important problem," she said.