- Gilead will donate enough of its preventive HIV therapy Truvada to treat as many as 200,000 uninsured Americans at risk for the virus each year, the biotech company and the U.S. government announced Thursday.
- While the company and government officials trumpeted the move as progress toward the Trump administration's goal of curbing new HIV infections, some activists and health policy experts questioned Gilead's motives.
- Just days ago, Gilead disclosed an earlier-than-expected entry date for generic competition to Truvada. Teva can launch a copycat version beginning Sept. 30, 2020 as part of a previous settlement reached between the two companies, according to a quarterly filing from Gilead.
While Gilead framed the donation as charity, the company also stands to benefit from wider adoption of pre-exposure prophylaxis, or PrEP.
PrEP has accounted for a good deal of sales of Truvada (emtricitabine/tenofovir disoproxil fumarate), but only a fraction of Americans at risk of HIV have received the drug for that use.
Patents on Truvada have staved off competition since the drug's initial approval in 2004. Recently, though, those legal protections have come under significant scrutiny.
Last month, the Justice Department began reviewing Gilead's patents on Truvada, following reporting from The Washington Post on the Centers for Disease Control and Prevention's role in developing the drug for preventive use.
Truvada secured its approval for PrEP in 2012.
"We believe making the drug available to the CDC likely helps address ongoing political rhetoric regarding the potential for Truvada to infringe upon CDC patents," RBC Capital Markets analyst Brian Abrahams wrote in a May 10 research note.
The donation could help PrEP "become further entrenched long-term and enable greater access for those at risk," the analyst added.
Since the donation is for uninsured Americans, it won't necessarily dent Gilead's commercial sales for patients insured commercially or through Medicare and Medicaid.
Some prominent HIV/AIDS activists voiced cynicism toward Gilead.
"Why the f--- didn't they do this 7 [years] ago?" tweeted Peter Staley, an activist involved with multiple AIDS groups including PrEP4All. "How many infections would have been prevented for just $10 million a year?"
Staley added that while he's "thrilled" for the expanded access, a generic version would have a greater impact.
Gilead has applied for approval of its newer HIV drug, Descovy (emtricitabine/tenofovir alafenamide), for use in PrEP. With generic competition to Truvada now around the corner, the company's long-term strategy is to spur uptake of Descovy.
Sales of Descovy for HIV treatment grew 30% year over year in 2018, while Truvada sales declined by 4%.
"The real cost of Truvada is about $60 a year. If you really wanted to cover everybody, you'd cut the price to everyone," Rochelle Walensky, an expert in HIV and AIDS at Massachusetts General Hospital, told The New York Times. "If you really wanted to cover everybody, you'd cut the price to everyone."
"If I put on my cynical hat, I think this is the way they make sure they grow the market for Descovy," she added.
The Foster City, California, biotech said it would transition donated drug from Truvada to Descovy if approved for PrEP.
Gilead estimates that about 18% of the 1.1 million Americans at risk for HIV receive Truvada for PrEP. Research has shown a predominant amount of prescriptions are written for white gay or bisexual men in the northeast or the West Coast.
"Stigma, lack of provider knowledge, and limited awareness among men who have sex with men represent substantial barriers to improving uptake in the communities at highest risk," a New England Journal of Medicine article from last October states.
"These factors are especially problematic in the South, where the incidence of HIV is the highest in the country and both mistrust of the medical system and perceived stigma against gay and bisexual men are prevalent," the authors wrote.
Under the Trump administration's HIV plan, the government aims to reduce new HIV infections by 90% in the next decade.