Activists Demand Gilead Rescind nPEP Patient Access Program's Once-Per-Lifetime Use Limit

Gilead Sciences is coming under fire from HIV/AIDS activist groups for a recent change to its patient assistance program (PAP). According to a letter sent to the company by the Fair Pricing Coalition, Treatment Action Group, and the National Association of State and Territorial AIDS Directors (NASTAD), Gilead's PAP has imposed a once-per-lifetime limit on access to Truvada (tenofovir/FTC) as part of non-occupational post-exposure prophylaxis (nPEP). While the company will undertake "hardship reviews" for subsequent prescriptions, the activists say the process is unclear and will create a significant barrier to access, especially since nPEP should be started within 72 hours of possible exposure to HIV.

"Not only should all HIV leaders -- and this includes pharmaceutical companies with skin in the game -- be making it easier, not harder, for people to access lifesaving treatment, they should be doing the same for infection-preventing options as well," said Tim Horn, a signatory of the letter who is deputy executive director of Treatment Action Group and chair of the Fair Pricing Coalition. "Seventy-two hours is precious little time, and providers shouldn't waste it climbing over 'hardship request' hurdles."

Post-exposure prophylaxis (PEP) refers to a combination of HIV medications prescribed to an individual who is HIV negative but may have recently been exposed to the virus. The Centers for Disease Control and Prevention (CDC) recommends that Truvada be used in combination with one of three other HIV drugs for PEP. The drug regimen should be started within 72 hours and taken for 28 days.

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PEP is often used for medical professionals who experience a needle stick or other on-the-job-exposure. Outside the medical profession, PEP can be used for victims of sexual assault or individuals who think they were exposed to HIV during unprotected sex or through sharing needles and works to prepare drugs. When it's used for any exposure outside a medical setting, it is referred to as nPEP or non-occupational post-exposure prophylaxis.

nPEP is intended for infrequent use. People who have an ongoing risk of contracting HIV through sexual behavior or drug use are better off using pre-exposure prophylaxis (PrEP), currently available only as daily Truvada, for long periods to prevent infection regardless of whether they've been exposed on any particular day.

The CDC guidance for nPEP suggests, "Persons who engage in behaviors that result in frequent, recurrent exposures that would require sequential or near-continuous courses of antiretroviral medications (e.g., HIV-discordant sex partners who inconsistently use condoms or [people who inject drugs] who often share injection equipment) should not be prescribed frequent, repeated courses of nPEP."

But, as the activists point out in their letter, there is a big difference between "near continuous" use and once, ever. Moreover, though some people who use PEP once, or more than once, might be better off on PrEP, this isn't universally true. Someone who uses condoms nearly 100% of the time but was potentially exposed twice over the course of three years would be a candidate for nPEP but not for PrEP. Under the current policy, this person would not qualify for the patient access program on the second exposure.

This change only impacts those who rely on Gilead's Patient Access Program: persons who are uninsured or underinsured and can't afford to pay for the medication out of pocket. To qualify for Gilead's PAP, an individual must make no more than 500% of the federal poverty line and not have insurance that will cover the drug.

HIV activists have clashed with Gilead before. Last summer, some urged New York's Attorney General to investigate the company for potential antitrust violations when it entered into deals with generic drug manufacturers that seemed designed to delay the availability of a generic version of Truvada. It costs approximately $9 to produce a month's supply of Truvada but Gilead sells that for $1,500; a generic version would make the drug cheaper and help many users paying out-of-pocket costs for the drug. In 2016, activists noted that Gilead raised the prices of some of its older HIV medications that were facing patent expiration in an apparent move to make newer drugs, which would stay lucrative longer, more appealing to providers.

This time activists are angry but also confused. Tim Horn told that this rule "just doesn't make sense."

The company has not explained its decision.

Horn said that the new rule does not seem to be based in reality or on the CDC guidance. He and fellow activists are asking the company to explain the reasoning behind the rule, but more importantly, they are asking the company to ensure that the rule does not prevent anyone from accessing PEP in a timely manner.

In their letter, Horn and his colleagues ask Gilead to rescind its new PAP policy immediately. The letter goes beyond that, however, noting that "we are again faced with a Gilead policy with a direct effect on the lives of people living with and vulnerable to HIV infection that has not been vetted or discussed with community advocates." They ask that the company "firmly establish mechanisms for meaningful community engagement."

Gilead replied to's request for information by saying that it plans to do just that. A spokesperson for the company said in an email: "Like those in the advocacy community, we are committed to helping ensure access to our medications. HIV/AIDS advocates play a critical role, and Gilead regularly engages with a wide range of community organizations, and we appreciate the ongoing, meaningful dialogue. We have received the letter from the Treatment Action Group, Fair Pricing Coalition, and NASTAD, and we will be responding soon."

Until that time, however, it remains unclear why the policy was put in place and whether it is here to stay.