‘A slap in the face’: Advocates trying to end HIV say threats to drug’s access are dangerous

Every night, Clint Haskell tosses a blue, square-shaped pill into his mouth, washing it down with a handful of water from the sink in his bathroom. The nightly routine provides Haskell peace of mind.

The pill — which is sold under the brand name Descovy — reduces Haskell’s chance of becoming infected with HIV by more than 90%. Haskell’s boyfriend is HIV positive, and Haskell is not. The nightly medication helps keep it that way.

The drug is part of a regimen known as pre-exposure prophylaxis, or PrEP and is a target of a lawsuit objecting to the drug’s use on religious grounds. A group of North Texans filed the suit in 2020, seeking to overturn the legal requirement that all preventive health care — including PrEP — be provided free of charge to patients with private health insurance.

Last month, U.S. District Judge Reed O’Connor in Fort Worth agreed with part of the plaintiffs’ argument, and wrote in his ruling that insurance companies did not need to fully cover the cost of all preventive health care. In addition, O’Connor found the requirement for insurance companies to pay for PrEP violates the plaintiffs’ religious rights. It’s unclear what will happen next; both the plaintiffs and the defendants have asked an appeals court to overturn O’Connor’s ruling, and it’s possible that a final decision might leave access to PrEP unchanged.

But regardless of how courts rule in the future, and how insurance companies respond to those decisions, the initial lawsuit and the subsequent ruling represent a threat to those at risk of HIV infection and those who are working to end the epidemic, advocates in North Texas said.

“The plaintiffs here are going after the LGBT community,” said DeeJay Johannessen, the executive director of the HELP Center, which provides PrEP for about 3,000 patients in North Texas.

Even if patients can continue to access PrEP unchanged, the lawsuit is perpetuating and increasing the stigma around HIV, said Ruben Ramirez, the director of community outreach for the AIDS Outreach Center in Fort Worth. The center provides PrEP for about 200 patients.

In the fight to end the HIV epidemic, “We’re kind of reversing course,” he said.

How the challenge originated in Fort Worth

There are six individual plaintiffs challenging access to PrEP: John Kelley, Ashley Maxwell, Zach Maxwell, Joel Miller, Gregory Scheideman and Joel Starnes. The other plaintiffs in the suit are Kelley’s business, Kelley Orthodontics, and Braidwood Management, a company based in the Houston area.

The group filed the case in the U.S. District Court in the Northern District of Texas in Fort Worth, where it was assigned to O’Connor, who previously overturned the entire Affordable Care Act in 2018. O’Connor’s ruling in that case was overturned by the U.S. Supreme Court.

The plaintiffs outlined a number of preventive health practices they opposed on religious and moral grounds, including PrEP, contraception, and testing for sexually transmitted infections. The group said they didn’t want to purchase health insurance that subsidized “PrEP drugs that encourage and facilitate homosexual behavior,” according to the complaint. They asked O’Connor to respond by overturning a key tenet of the Affordable Care Act: The requirement that all preventive health services are free to patients with insurance, meaning the insurer has to cover the cost in full.

Instead, O’Connor agreed with only part of the plaintiffs’ argument. His ruling focused on recommendations from the U.S. Preventive Services Task Force, an independent group of national experts in primary care medicine. Under the Affordable Care Act, any preventive service given an “A” or “B” rating from the task force meant health insurance companies had to cover the cost of that service in full, with no charge to the patient. In his ruling, O’Connor wrote that the task force doesn’t have the authority to make these recommendations, and ruled that any recommendation the task force has made since 2010 doesn’t have to be covered in full by health insurance. That includes recommendations like PrEP for people at a higher risk of HIV infection, but also taking statins to prevent heart disease for adults who are at a higher risk.

If O’Connor’s ruling stands, insured patients could be charged a co-pay or deductible to these services, which were previously offered completely free to the patient.

The federal government has asked the Fifth Circuit Court of Appeals to overturn the decision, and the plaintiffs have filed a motion of cross-appeal. Even if O’Connor’s decision remains in effect, some insurance companies might choose to continue to provide PrEP without charging patients.

The plaintiffs’ attorneys did not respond to phone calls or emails asking for comment.

PrEP’s role in effort to end HIV epidemic

When PrEP was first approved as a method to prevent HIV infection in 2012, it was a game changer in the long battle to stop new HIV infections. When taken daily, PrEP drugs can be up to 99% effective in preventing HIV transmission through sex, and up to 80% effective at preventing infection through drug use.

Since it was approved, getting more people at risk of HIV infection to take PrEP has been a key component in combating the spread of HIV.

Four years ago, public health officials with the Trump administration announced a plan for the future of the HIV epidemic in the U.S.: Reduce the number of new infections by 90% by the year 2030. To achieve that goal, the federal government created a new program to offer PrEP for free to people without insurance, and focused its efforts on Tarrant, Dallas, and the 46 other counties nationwide where the majority of new HIV cases were diagnosed each year.

But that progress toward that goal has been hampered significantly by the COVID-19 pandemic, which caused patients to miss screenings and public health workers to focus on the coronavirus. The ambitious goal outlined in 2019 is unlikely to be possible, Dawson said.

“We don’t have a full picture yet, but we’re certainly not close to that 90% reduction,” Dawson said.

HIV in Tarrant County

If access to PrEP is reduced in the wake of O’Connor’s ruling, public health experts expect more HIV diagnoses to follow.

One analysis, published in the journal Open Forum Infectious Diseases, estimates for every 10% decrease in PrEP coverage, there could be another 1,140 HIV infections diagnosed in the following year among gay men.

Those who are trying to reduce the number of new HIV diagnoses say that the nation needs more people, not fewer, to be taking PrEP medications.

Only about 25% of people who are at risk of HIV infection are on a PrEP regimen. In Tarrant County, that share could be even worse: A report from 2018 found that only one of every 10 county residents who could benefit from PrEP was taking it. That same year, there were 287 new diagnoses of HIV in Tarrant County, according to state data. More recent data has not yet been published.

And even as public health workers are trying to get more people at risk for HIV to learn about PrEP, they are also grappling with longstanding disparities: Of those people who do take PrEP, two out of every three are white, according to federal data. In 2019, the overwhelming majority – 76% – of new HIV diagnoses in Texans were in Black and Hispanic people, according to state data.

Samantha Mitchell, a nurse practitioner at the AIDS Outreach Center in Fort Worth, said O’Connor’s decision seemed to indicate that a misunderstanding of what PrEP is and how it provides protection to everyone, not just gay men.

“Our goal is to protect, all mankind, not just a certain group,” Mitchell said. “I really think that individuals that don’t have that subject matter expertise really shouldn’t make rulings on it.”

Mitchell said she’s extremely worried that the number of people with new HIV infections could continue to grow, especially because sexually transmitted infections like gonorrhea and syphilis are continuing to rise rapidly throughout the U.S. and in Texas.

Wil Mitchell, an AIDS Outreach Center worker who himself is HIV positive, said O’Connor’s decision felt like “a slap in the face” to their work to end the epidemic.

But advocates have also said its important not to lose sight of the impact this will have on the individuals who take PrEP medication daily to keep themselves safe and healthy. For Clint Haskell, his nightly routine is an important part of his well-being.

For him, PrEP means “I could be free to fully love my boyfriend,” he said.

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