January 25, 2018
Gregg H. Alton
Executive Vice President
Corporate and Medical Affairs
Gilead Sciences
333 Lakeside Drive
Foster City, CA 94404
Dear Gregg:
A deeply concerning issue has been brought to our attention: Gilead Sciences is limiting access to Truvada (tenofovir disoproxil plus emtricitabine) as a component of nonoccupational postexposure prophylaxis (nPEP) through its patient assistance program (PAP) to once in a lifetime, with hardship review criteria and processes for subsequent prescriptions that have not been clearly articulated and are likely a considerable barrier to nPEP by uninsured and underinsured U.S. residents. We believe this policy is unethical and incompatible with CDC guidelines and we implore you to immediately end such an unreasonable policy, in favor of a transparent and accommodating policy that ensures unencumbered and streamlined access to nPEP for those vulnerable to HIV infection.
While no randomized, placebo-controlled clinical trials have been conducted to fully evaluate the safety and efficacy of nPEP, including regimens containing Truvada, numerous observational studies in men who have sex with men, victims of sexual assault and other populations have yielded strong evidence that nPEP can reduce the risk of acquiring HIV infection when started within 72 hours of exposure and continued for 28 days.[1]
We concur with the following public health guidance from the U.S. Centers for Disease Control and Prevention (CDC):
nPEP should be provided only for infrequent exposures. 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. Instead, health care providers should provide persons with repeated HIV exposure events (or coordinate referrals for) intensive sexual or injection risk-reduction interventions, and consider the prescription of daily oral doses of the fixed-dose combination of TDF and FTC (Truvada, Gilead Sciences, Inc., Foster City, California) for PrEP. However, if the most recent recurring exposure is within the 72 hours prior to an evaluation, nPEP may be indicated with transition of the patient to PrEP after completion of 28 days of nPEP medication.[1]
Gilead’s once-in-a-lifetime PAP allowance for Truvada as nPEP is, at best, incongruent with this guidance. First and foremost, there are important variations on the spectrum between one-time utilization of nPEP and “sequential or near-continuous courses of antiretroviral medications.” Examples include individuals who rely primarily on condoms to prevent HIV infection with occasional lapses in use or condom failures and sexual assault victims.
Second, not all nPEP users are effectively screened for PrEP, have easy and affordable access to knowledgeable and culturally competent PrEP providers and laboratory testing, or are deemed suitable candidates for PrEP.
Third, the CDC guidance is intended for health care providers and people with nonoccupational risk factors for HIV infection. They are not binding regulations for pharmaceutical companies manufacturing any of the preferred or alternative components of nPEP or the PAPs ensuring their availability to uninsured or underinsured individuals meeting financial eligibility criteria. Manufacturers’ overly stringent interpretation of public health guidance should in no way supersede critical decision making by health care providers and their patients, particularly when it comes to a drug product recommended by CDC for emergency medical care to prevent HIV infection.
Fourth, any effort by Gilead to steer individuals to PrEP – particularly as it commercializes the only U.S. Food and Drug Administration-approved regimen for PrEP – through dubious and overly stringent restrictions to nPEP access through its PAP is unethical.
Fifth, while we understand that a “hardship review” can be requested in the event a second (or subsequent) course of nPEP is prescribed by a health care provider and must be accessed through the PAP, we cannot begin to comprehend how it is Gilead’s responsibility to determine whether a person with a potential subsequent exposure to HIV should or should not receive an important intervention to prevent infection. Not only is “hardship review” highly stigmatizing language, it strongly indicates an added level of scrutiny that ultimately translates into a barrier in a process that is extremely time-sensitive and should be streamlined wherever possible.
In addition to the alarming PAP restriction that necessitates this letter and immediate rectification by Gilead, 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. We trust that, with this particularly egregious example of dangerous policy, Gilead Sciences will firmly establish mechanisms for meaningful community engagement.
In the meantime, and without delay, we urge Gilead to lift its once-in-a-lifetime PAP access policy for Truvada as a component of nPEP—thereby minimizing the need for the additional, time-consuming onus of hardship requests–and instate a policy that fully supports the capacity of health care providers and patients to make their own informed, medically sound decisions regarding primary HIV prevention. We would also appreciate a written response to this letter, specifically noting changes to Gilead’s policy for nPEP access through its PAP and the timeline for implementation.
Sincerely,
Tim Horn
Chair
Fair Pricing Coalition
Mark Harrington
Executive Director
Treatment Action Group
Murray Penner
Executive Director
NASTAD
[1] U.S. Centers for Disease Control and Prevention. Updated guidelines for antiretroviral postexpsoure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV–United States, 2016. 2016 May. Available from: https://stacks.cdc.gov/view/cdc/38856