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Gilead’s New Drug Descovy Spotlights Old Cracks in HIV Care

Aug. 14, 2019, 9:35 AM

When Nicole Price was first diagnosed with HIV, her initial reaction was similar to what a lot of HIV-positive women first think: This doesn’t happen to women.

Price was diagnosed in 2000, when Magic Johnson was the heterosexual face of HIV and it wasn’t common knowledge outside medical communities that women could even get the disease. “It was this idea that it was just gay people and people who shot up drugs,” she said.

That hasn’t changed much, said Price, who up until May worked as a program manager for the female HIV support group BABES Network in Seattle. “When newly diagnosed women come in, it’s the same thing that I thought 19 years ago,” she said. “They thought it didn’t happen to women.”

Even as the science around HIV treatment and prevention moves forward at a brisk pace, much of the public image around the disease and who’s at risk remains static. That problem is exacerbated by clinical studies for HIV drugs that don’t accurately reflect the populations that need them.

And as the Trump administration and drug companies like Gilead Sciences Inc. try to quell new cases of HIV, representatives for black, transgender, and female HIV patients question whether federal and state authorities have the know-how to reach those marginalized populations that traditional health systems have let slip through the cracks.

“Several people there wouldn’t know where to find a black gay man, a black trans woman to have a real conversation with as to why or why not they would take a drug or not take a drug,” said Kirk Myers, CEO of a health education nonprofit called Abounding Prosperity in Dallas that focuses specifically on black communities.

“That’s problematic that people can talk with conviction about a population that they don’t interact with on a daily basis,” he said, referring to predominantly white HIV advocates or health-care workers in the HIV space.

An Old Criticism Renewed

It’s an old criticism that reared its head again last week when drug manufacturer Gilead presented its drug Descovy to a Food and Drug Administration advisory panel.

Gilead scientists want the agency to approve Descovy for HIV prevention in women, men who have sex with men, and transgender women. But the company didn’t include women in its Descovy clinical trial and about 2% of participants were transgender women. Nine percent of participants were black.

The panel eventually recommended Descovy for approval for men who have sex with men and transgender women who have sex with men, but shot down Gilead’s request to recommend approval for Descovy for women. Many panelists said they believed the drug would be effective but the drugmaker hadn’t provided enough data to prove it.

In 2017, women made up 19% of new HIV diagnoses in the U.S., according to the Centers for Disease Control and Prevention. Fifty-nine percent of those women were African American. Black gay and bisexual men accounted for the largest number of new HIV diagnoses in 2017, according to CDC data.

And although HIV diagnoses among white gay and bisexual men decreased 14% from 2012 to 2016, the rate for African Americans remained the same. For Hispanic/Latinos that rate increased 12%.

The conversation last week among FDA panelists and members of community health organizations highlighted not only poor clinical trial representation, but HIV treatment disparities generally—particularly when race, gender, or region come into play.

The Bible Belt Buckle

According to June Gipson’s records, her organization My Brother’s Keeper provides 75% of the HIV prevention drugs in Mississippi.

“We’re not that small,” Gipson said, referring to Mississippi. “It seems like we should be providing 75% of PrEP for a county or for a metropolitan area” rather than the whole state, she said.

PrEP stands for pre-exposure prophylaxis, which is a type of HIV prevention medicine. Currently Gilead’s Truvada is the only one on the market, but the drugmaker is pushing Descovy for PrEP now too. The company’s patent on Truvada is set to expire next year.

Gipson breaks it down to a core problem: access.

“We’re the buckle of the Bible Belt, so it can be even more stringent here,” but a more culturally conservative society isn’t the only reason for access issues, she said.

Because physicians are silo-ed within their specialties, unless a doctor deals with HIV or reproductive health specifically “they don’t see themselves as an expert in prescribing PrEP,” Gipson said.

Role of Kidney Health

Patients at Gipson’s clinic are also hesitant to take Truvada because of the fear of kidney damage—one of the potential side effects of the drug. Mississippi has the highest kidney disease mortality rate of any state, according to the CDC. That’s why Gipson supports approval of Descovy for everyone—including women.

In the Descovy-as-PrEP clinical trial the data signaled better kidney and bone health for patients using Descovy versus Truvada, which is pushing Gilead representatives to say Descovy is safer than Truvada. But there were never any clinical differences between the two drugs. That means no one had permanent kidney damage in the trial using Truvada versus Descovy and no one had a fragility fracture either.

But even if the safety profile for Descovy as an HIV prevention drug isn’t technically better than Truvada, the perception of better safety would push Gipson to prescribe Descovy to her patients over Truvada, she said. Continuing to take the drug is the only way it’s effective, so trust in the drug is important.

Although the FDA advisory committee said through their 10-to-8 vote that Gilead hadn’t provided enough data to show Descovy was effective for women, the agency could still approve it for a wider indication.

“I’m so torn in what to do next in this scenario,” Gipson said. “But I do know it sent a horrible message to women.”

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Randy Kubetin at rkubetin@bloomberglaw.com

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