Saudi Press

Saudi Arabia and the world
Friday, Aug 22, 2025

FDA Approves New HIV-Prevention Drug, but Not for Women

FDA Approves New HIV-Prevention Drug, but Not for Women

The Food and Drug Administration on Thursday approved a new drug, Descovy, for prevention of infection with HIV, only the second drug approved for this purpose.The first, Truvada, has become a mainstay of government efforts to turn back the HIV epidemic. But the FDA approved Descovy for use only in men
The Food and Drug Administration on Thursday approved a new drug, Descovy, for prevention of infection with HIV, only the second drug approved for this purpose.

The first, Truvada, has become a mainstay of government efforts to turn back the HIV epidemic. But the FDA approved Descovy for use only in men and transgender women, because its maker, Gilead Sciences, tested it only in those groups.

The approval explicitly excludes women and does not outline a plan for making the drug available to them. Some activists and scientists said the approval sets a dangerous precedent by allowing companies to dodge expensive trials needed to test medicines in women.

Such an exclusion of women “should be unacceptable in these days and times,” said Dr. Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital.

It’s important to test the drug specifically in women, she added, because Descovy may work differently in the vagina than in rectal tissues.

The FDA, in fact, will require Gilead to study Descovy in women, company officials said. Gilead is considering a trial in Africa.

Gilead also makes Truvada. Both medicines are to be taken daily, an HIV-prevention strategy called preexposure prophylaxis, or PrEP.

The company has come under heavy criticism for selling Truvada at a high cost, currently about $20,000 a year. Critics have said the expense keeps the drug out of reach of Americans who would benefit from it. Few patients actually pay the full price, Gilead has said.

Less expensive generic versions of Truvada are expected next year, as the drug’s patent protections expire. But Descovy’s approval ensures Gilead’s continued dominance of the market for PrEP, said Jeremiah Johnson, a project director at Treatment Action Group, an advocacy organization.

Descovy is not more effective than Truvada, Johnson noted. But in various presentation materials, Gilead on occasion has hinted that it is, and Johnson and others fear patients may reject affordable and accessible generic versions of Truvada in favor of the more expensive Descovy.

Any suggestion that Descovy is more effective than Truvada was unintentional, said Diana Brainard, who oversees Gilead’s HIV division. The company’s message, she added, is that both Descovy and Truvada are highly effective at preventing HIV infection when taken daily.

“It’s always good to have choice,” she said.

Descovy’s patent is supposed to expire in 2026, but a nonprofit group called Prep4All Collaboration hopes to find a way to end it in 2022.

The group had been running a campaign called “Break the Patent” to limit Truvada’s patent protection, which was supposed to expire in 2021. But in May, Gilead announced that a generic version would be available next year.

“As of today, we’re adding an ‘s’ — it’s ‘Break the Patents,’ ” said Peter Staley, a founder of the collaboration.

Descovy contains a newer version of tenofovir, the active ingredient in Truvada. Gilead tested Descovy in a multinational trial that included 5,313 men and 74 transgender women who have sex with men. There were no cisgender women, and 84% of the participants were white.

“They did a terrible job of inclusion for a company that dominates the market,” Johnson said.

There are some data suggesting that Descovy has fewer side effects on bones and kidneys than Truvada, but those problems have only been seen in a small number of people taking Truvada, Walensky said.

She also noted that although Gilead scientists have presented some of their data at conferences, they have yet to publish their results in a peer-reviewed journal.

At a hearing in August, some activists urged the FDA to deny approval for use of Descovy in women or to require Gilead to test the drug in a large number of women promptly after approval.

Unless forced to do so by the FDA, critics said, the company has no motivation to test the drug in women.

“We had at least hoped that they would say something the day they approved it without an indication for women, that they would have a plan or forceful language laid out on how this disgraceful situation is going to be rectified,” Staley said.

Although the FDA’s announcement does not mention it, the agency is requiring such a study.

Brainard said Gilead plans to start the study in at least 1,500 high-risk women in southern Africa — where the incidence of HIV in women is higher than in the United States — by the end of 2020. The FDA’s approval letter requires the company to complete the trial by December 2024.

Walensky said she is disappointed by the numbers and timeline of that trial.

“I want to see a large-scale, rapid effort to get data in women as soon as possible,” she said. “That, in my mind, is the only way to rectify this.”
Newsletter

Related Articles

Saudi Press
0:00
0:00
Close
Dogfights in the Skies: Airbus on Track to Overtake Boeing and Claim Aviation Supremacy
Tim Cook Promises an AI Revolution at Apple: "One of the Most Significant Technologies of Our Generation"
Are AI Data Centres the Infrastructure of the Future or the Next Crisis?
Miles Worth Billions: How Airlines Generate Huge Profits
Zelenskyy Returns to White House Flanked by European Allies as Trump Pressures Land-Swap Deal with Putin
Beijing is moving into gold and other assets, diversifying away from the dollar
Cristiano Ronaldo Makes Surprise Stop at New Hong Kong Museum
Zelenskyy to Visit Washington after Trump–Putin Summit Yields No Agreement
High-Stakes Trump-Putin Summit on Ukraine Underway in Alaska
Iranian Protection Offers Chinese Vehicle Shipments a Cost Advantage over Japanese and Korean Makers
Saudi Arabia accelerates renewables to curb domestic oil use
Cristiano Ronaldo and Georgina Rodríguez announce engagement
Asia-Pacific dominates world’s busiest flight routes, with South Korea’s Jeju–Seoul corridor leading global rankings
Private Welsh island with 19th-century fort listed for sale at over £3 million
Sam Altman challenges Elon Musk with plans for Neuralink rival
Australia to Recognize the State of Palestine at UN Assembly
The Collapse of the Programmer Dream: AI Experts Now the Real High-Earners
Armenia and Azerbaijan to Sign US-Brokered Framework Agreement for Nakhchivan Corridor
British Labour Government Utilizes Counter-Terrorism Tools for Social Media Monitoring Against Legitimate Critics
WhatsApp Deletes 6.8 Million Scam Accounts Amid Rising Global Fraud
Nine people have been hospitalized and dozens of salmonella cases have been reported after an outbreak of infections linked to certain brands of pistachios and pistachio-containing products, according to the Public Health Agency of Canada
Texas Residents Face Water Restrictions While AI Data Centers Consume Millions of Gallons
Tariffs, AI, and the Shifting U.S. Macro Landscape: Navigating a New Economic Regime
India Rejects U.S. Tariff Threat, Defends Russian Oil Purchases
United States Establishes Strategic Bitcoin Reserve and Digital Asset Stockpile
Thousands of Private ChatGPT Conversations Accidentally Indexed by Google
China Tightens Mineral Controls, Curtailing Critical Inputs for Western Defence Contractors
OpenAI’s Bold Bet: Teaching AI to Think, Not Just Chat
BP’s Largest Oil and Gas Find in 25 Years Uncovered Offshore Brazil
JPMorgan and Coinbase Unveil Partnership to Let Chase Cardholders Buy Crypto Directly
British Tourist Dies Following Hair Transplant in Turkey, Police Investigate
WhatsApp Users Targeted in New Scam Involving Account Takeovers
Trump Deploys Nuclear Submarines After Threats from Former Russian President Medvedev
Germany’s Economic Breakdown and the Return of Militarization: From Industrial Collapse to a New Offensive Strategy
IMF Upgrades Global Growth Forecast as Weaker Dollar Supports Outlook
Politics is a good business: Barack Obama’s Reported Net Worth Growth, 1990–2025
"Crazy Thing": OpenAI's Sam Altman Warns Of AI Voice Fraud Crisis In Banking
Japanese Prime Minister Vows to Stay After Coalition Loses Upper House Majority
President Trump Diagnosed with Chronic Venous Insufficiency After Leg Swelling
Man Dies After Being Pulled Into MRI Machine Due to Metal Chain in New York Clinic
FIFA Pressured to Rethink World Cup Calendar Due to Climate Change
"Can You Hit Moscow?" Trump Asked Zelensky To Make Putin "Feel The Pain"
Nvidia Becomes World’s First Four‑Trillion‑Dollar Company Amid AI Boom
Iranian President Reportedly Injured During Israeli Strike on Secret Facility
Kurdistan Workers Party Takes Symbolic Step Towards Peace in Northern Iraq
BRICS Expands Membership with Indonesia and Ten New Partner Countries
Elon Musk Founds a Party Following a Poll on X: "You Wanted It – You Got It!"
AI Raises Alarms Over Long-Term Job Security
Saudi Arabia Maintains Ties with Iran Despite Israel Conflict
Russia Formally Recognizes Taliban Government in Afghanistan
×