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Why has pharmaceutical giant Gilead been criticized for promising to provide free HIV "pre-exposure prophylaxis" in the U.S.?

Pharmaceutical giant Gilead has pledged to donate HIV treatment and "pre-exposure prophylaxis" (PrEP) drugs to up to 200,000 people a year, with free PrEP drugs meaning the company will provide up to 2.4 million bottles of Truvada each year. The agreement was hailed as an important step toward reducing - and ultimately preventing - HIV in the U.S., but Gilead has subsequently faced new criticism for its efforts to price the drug and control the PrEP market.

Under the donation agreement, Gilead will provide up to 2.4 million bottles of Truvada per year to the Centers for Disease Control and Prevention (CDC). They will be distributed to Americans who currently do not have health insurance.

The agreement is expected to last until the end of 2025. However, Gilead said it could be extended to the end of 2030. This is the deadline by which U.S. President Donald Trump has promised to "end the AIDS epidemic" in the country.

Truvada is both a therapeutic and prophylactic drug, although it does not cure AIDS. The U.S. FDA approved its use for HIV prevention in 2012, especially for high-risk groups. Depending on the study, efficacy rates can vary, but continued use can result in a reduction in the incidence of HIV infection of between 50 and 100 percent.

"Approximately 200,000 of the estimated 1.1 million Americans living with HIV are currently receiving Truvada for PrEP," Gilead said of the protocol. "Widespread use in high-risk populations is hampered by serious social and structural barriers, such as the phenomenon of HIV stigma, homophobia, limited provider and patient awareness of PrEP, and an overall lack of access to healthcare."

Yet the drug company has faced criticism in recent years over drug pricing for Truvada and other drugs.

For example, in 2014, Gilead launched a treatment for hepatitis C. Activists and politicians alike slammed the company's roughly $90,000 price tag for the drug, which Gilead argued was a fair pricing given the lifetime cost of treating existing livers. Since then, Gilead has offered the drug at a steep discount in some areas.

Recently, health activists criticized the company's Truvada pricing. In the U.S., the PrEP drug typically costs between $1,600 and $2,000 per month, a pricing that has been accused of not being considerate for many people. In fact, Gilead has increased the pricing of Truvada since it first withdrew seven years ago. The upcoming release is a generic version of Truvada, the patent for which is set to expire next year.Teva Pharmaceuticals is set to launch this generic product in September 2020, which is expected to significantly reduce costs.

Gilead's response will be to develop a new drug, Descovy. this is newer than Truvada and shares an active ingredient with the PrEP drug, but will not be off patent anytime soon. While Descovy is currently approved for HIV treatment, the FDA is currently evaluating it for preventative use. If approved, Gilead said the donation would translate into a newer, patented drug.

It's some much-needed good PR for Gilead, not to mention the possibility of tax deductions for donations. It also helps the company avoid lowering Truvada's pricing, something AIDS activists have long called for. In the process, the company could also build brand awareness and loyalty.

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