'Unconscionable': HIV community in legal fight with Bay Area drugmaker

Hank Trout was diagnosed with HIV in 1989 at the age of 36.

The longtime San Francisco resident resisted medication at first, but eventually began the fraught medication journey with which those living with the condition are familiar — a drug “cocktail” involving a strict regimen of several medications a day.

After trying several such combinations of drugs to keep his HIV levels in check, he eventually started taking just one drug — tenofovir disoproxil fumarate.

After about 10 years of taking a combination drug known as Truvada that includes TDF, Trout said, he started experiencing severe bone-density loss. About eight years ago, he was diagnosed with osteoporosis. Although he was only in his 60s at the time, his bone-density loss was comparable to that of men 20 years older.

And that wasn’t the end of his troubles. By now, he’s shrunk four inches, in part due to six compression fractures in his spine. He’s had several back surgeries. Just a couple of years ago, he fractured his pelvis just stepping off a curb. There have been times when he’s been confined to a wheelchair, he said, and he now walks with a cane.

“For several years now, I’ve been in constant pain,” Trout said. “It’s the first thing I’m aware of when I wake up, and the last thing I’m aware of before I go to bed.”

Trout and thousands like him in California are trying to hold TDF manufacturer Gilead Sciences responsible for their pain and suffering. They’re part of a lawsuit filed against Gilead in 2019 that accuses the Foster City-based pharmaceutical company of failing in their duty to bring a similar drug to market with less severe side effects sooner.

For its part, Gilead has been fiercely fighting back. After its motion for summary judgment of the case was denied in San Francisco Superior Court, the company went to the California Court of Appeal. When that court ruled against Gilead in January, it appealed again to the Supreme Court of California, the state’s highest court, which agreed in May to hear the appeal. Gilead filed its first brief earlier this month.

Robert Jenner, co-lead counsel for Trout and the other plaintiffs said that the process will take some time, with a decision unlikely to come before the fall of 2025.

Jenner said the case hinges on the idea of negligence, not liability.

“You have to show there’s an obligation to do something,” said Jenner. “They didn’t do that obligation. They failed in that obligation, and that failure caused the harm.”

In its motion, Gilead argued there’s no legal basis for it because the medication and the warnings included with it was not defective.

The company welcomes the Supreme Court of California considering and ruling on its motion, a representative said in a statement to The Examiner.

With its decision rejecting Gilead’s appeal in January, “The Court of Appeal overrode a century of common law to impose on manufacturers a duty that no court anywhere in the country has ever suggested,” the representative said.

The lawsuit against Gilead accuses the company of promoting TDF while ceasing to develop a related drug, tenofovir alafenamide fumarate. TAF can be prescribed at lower doses than TDF while still having the same level of effectiveness, decreasing the risk of severe side effects, according to the law suit.

Gilead began developing TDF in 1991, and in 2001 applied for FDA approval of the medication. That same year, it began development of TAF, but it stopped in 2004 due to the drug’s similarities with TDF, which was already on the market.

Despite knowing TAF was safer, Gilead continued pushing TDF-type medications for the next several years so the company could maintain its monopoly over such drugs until its patent expired, the lawsuit alleges. Gilead offers five different TDF drugs — Viread, Atripla, Complera, Stribild and Truvada.

Gilead didn’t resume development of TAF until 2011, and applied for FDA approval of TAF in 2015 — around the time TDF’s patent was set to expire.

In a statement to the Examiner, a Gilead spokesperson said: “Both TDF- and TAF-containing medicines are approved by the FDA [and] successfully helping to treat and prevent HIV in millions of people.”

But Jenner said that the lawsuit isn’t questioning the efficacy of TDF. Instead, it’s charging that Gilead forced people to take a product that had more severe side effects when it had another option that could have been developed instead. Under California law, people and companies can be held responsible for injuries to others, even if they didn’t mean to cause harm, if those injuries are due to their “reckless negligence.”

“There was something that you could have and should have released earlier so that people wouldn’t have to take the less safe product,” he said. “That’s negligence.”

While Trout’s side effects have been more severe than others have experienced, he’s not alone in coming to terms with them.

Local activist Paul Aguilar, 61, blames Truvada for his height loss. After taking the drug for several years, he went in for a medical checkup in 2014 and had his height measured.

“They said, ‘Well, you’re 6 feet tall.’ And I said, ‘No, I’m six-four,” said Aguilar.

He kept arguing with staff until he finally went home and measured himself, he said, and found that he was indeed now just six feet tall. His physician had him take a bone-density test, which found that Aguilar had developed osteopenia, a precursor to osteoporosis.

Aguilar was floored. When he first began taking Truvada, it felt like a “miracle.” Previously, to manage his HIV, he’d had to take “17 pills a day,” he said.

“My viral load went undetectable almost immediately” after starting to take Truvada, he said. “We were all very happy. Life went on.”

After he learned about his height loss, he was able to switch over to a TAF drug. (Gilead has introduced four such medications to the market: Genvoya, Odefsey, Descovy and Biktarvy.) But the damage was already done, both physically and mentally.

“When you find out that a pharmaceutical company knowingly withheld a drug that had fewer effects than one that they were currently peddling because of profits, that really undermines the whole trust of the medical community,” he said.

Gilead’s alleged actions have particularly negative resonance and connotations in the HIV-positive community, due to the community’s history with experimental drugs dating back to when the epidemic first began.

“Here we are again, 40 years later, being used as guinea pigs,” said Aguilar, who has joined the lawsuit as a plaintiff. “This time it was unconscionable, because they knew what the side effects were and what it was doing, as opposed to 40 years ago, when it was a brand new drug.”

David Troup, 60, another San Francisco resident and plaintiff in the lawsuit, shares this sense of betrayal.

Troup said he took Viread, a TDF medication, for several years. Like Aguilar, he was diagnosed with osteopenia. He also lost about six teeth due to the side effects of the drug and ended up spending around $40,000 to deal with the consequences of his tooth loss, he said.

“I always had assumed that human beings at those companies would never prioritize profits over the health outcomes of the patients using the drugs,” said Troup. “Now I realized that was a naive assumption.”

Although some compensation for the expenses he’s accrued would be “nice,” Troup said he didn’t join the lawsuit out of financial motivations.

“My entire reason to want to be part of this lawsuit is that I think that a company that engages in this kind of behavior — where they’re putting profits ahead of the health of patients and doing it knowingly, they need to be punished,” he said. “They need to be sent a message that this is not okay.”