Why Are HIV Groups Charging Gilead With Bad Behavior in New PrEP Trial?
November 16, 2016
Truvada (FTC/TDF) is approved for use as PrEP in many countries and has been proven safe and highly effective at reducing the risk of HIV transmission. Descovy (FTC/TAF) is a relatively new pill being tested in this trial to see whether it is also safe and effective as PrEP.
When Truvada's patent expires in the United States in 2021, a generic (and potentially less expensive) version of it will become available. Meanwhile, if Descovy works as PrEP, Gilead will be able to fend off generic competition a bit longer. Gilead -- the manufacturer of both Truvada and Descovy -- will promote it as "new and improved" PrEP, making high profits off it even though an affordable, effective generic alternative will also exist. In 2015, Gilead made over $32 billion in product sales. At a September 2016 meeting with the company (which we attended courtesy of AVAC), one American activist called Gilead's strategy of quickly filling the niche market with patented Descovy a "blatant patent protection money grab."
Containing emtricitabine (FTC) and tenofovir alafenamide (TAF), Descovy is a variation on the Truvada formulation of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). Three months after the FDA approval of Descovy for treatment, a clinical trial of Descovy as PrEP showed up on the ClinicalTrials.gov listings. This trial, called DISCOVER, expects to enroll 5000 participants (men who have sex with men and transgender women who have sex only with men) in 92 study sites across ten countries in North America and Western Europe. Results are expected by 2020, and Gilead is self-funding the trial with no outside support.
Unlike the Truvada PrEP trials, DISCOVER is alarming HIV prevention advocates and causing them to have flashbacks. Between 2003 and 2005, the first PrEP trials tried to launch in Cambodia and Cameroon. Both were cancelled abruptly, wasting funding, time and effort, because the trial organizers did not involve the host communities from the outset in trial design and implementation. Nor did they pay adequate attention to the issues community members were raising and their human rights concerns. Coincidentally, the product being tested was Gilead's tenofovir disoproxil fumarate (TDF) (although Gilead's participation in both trials was limited to supplying product only).
The Cambodian trial, funded by the U.S. National Institutes of Health and others, proposed to enroll 960 sex workers. The government cancelled it before enrollment started because the sex workers instigated highly public protests after the investigators' repeated refusals to negotiate with them on key issues. A similar PrEP trial was halted in Cameroon the next year by the national Ministry of Public Health. After recruitment started, ACT-UP Paris and Réseau éthique Droit et Santé (REDS, a Cameroonian AIDS activist group), led highly publicized actions highlighting concerns about trial conduct and the delivery of care to participants.
UNAIDS responded to these unexpected trial closures and the controversy that surrounded them by hosting a meeting to discuss how such disasters could be prevented in the future. One outcome of the consultation was that several organizations, led by AVAC and UNAIDS, created the Good Participatory Practice (GPP) guidelines, published in 2007 and updated in 2011. The GPP systematically walks trial funders and implementers through the steps needed to engage all relevant stakeholders in designing and implementing biomedical HIV prevention trials. It is modeled after existing standards, including Good Laboratory Practices, Good Manufacturing Practices and Good Clinical Practices.
Regulatory authorities in many countries enforce these standards to protect research participants, patients and consumers from being injured by products or their development process (including research). These regulators do not require adherence to GPP, but AVAC reports that many well-respected clinical trial funders and implementers have incorporated it into the work -- among them some of the NIAID networks, the Microbicide Trials Network, the HIV Vaccine Trials Network, Family Health International 360 and the Janssen Pharmaceutical Companies of Johnson & Johnson. Using GPP as a "best practice" tool protects them ethically, and it effectively prevents the kind of trial disruption that can occur when community and stakeholder participation is absent or insufficient.
Fast forward to July 2016: When Gilead announced the DISCOVER trial, about 20 activists, ourselves included, met with Gilead representatives to express concern about the obvious lack of community involvement. In particular, we raised serious ethical and logistical concerns about the trial design, duration, enrollment criteria, informed consent and other issues on which community input would be valuable. How, we asked, would Gilead handle trial enrollment in countries where national health systems don't cover PrEP? People who need PrEP may enroll in DISCOVER for the 50% chance of getting Truvada (known to be effective) -- even at the risk of getting Descovy, with unknown effectiveness. How would Gilead ensure that trial sites -- under pressure to enroll participants -- would make this inherent risk as clear as it needed to be to the participants considering enrollment?
This conversation led to a September meeting between Gilead staff and a larger group of North American and European activists, at which multiple issues were raised. The advocates also asked why some investigators were making unsupported claims that Descovy was a "newer, better" PrEP and why trial sites were using recruitment materials that looked very much like product advertisements.
At this in-person meeting in September, we urged Gilead to temporarily halt the trial until key concerns could be addressed, including the establishment of mechanisms for appropriate community engagement. This request was repeated in a follow-up letter.
Gilead agreed to form an interim Community Advisory Board (CAB), and a Nov. 10, 2016, communiqué from Gilead affirmed that they have made a number of changes to the protocol and its implementation. However, the community has not been given a role in those reviews. Despite its promises, Gilead has yet to substantially demonstrate a commitment to real stakeholder engagement or Good Participatory Practice guidelines. As a result, activists are now releasing a public sign-on letter to Gilead featuring the following demands:
As the sex workers in Cambodia understood twelve years ago, the right to speak out and to withhold one's cooperation is a strong tool.
Anna Forbes is a Washington, D.C.-based writer, organizer and activist working in HIV/AIDS since 1985. Now an independent consultant focused on women's HIV-related needs and rights, her current and recent clients include a wide range of HIV-focused domestic and international NGOs and human rights initiatives.
Marc-André LeBlanc has worked in the community-based HIV movement for over 20 years at local, national (Canadian) and international levels. Much of this time has been spent advocating for the development of new HIV prevention options, mobilizing communities, and building capacity of service providers.
This article was provided by TheBody.
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