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Regulatory filing and review delays keep Truvada as pre-exposure prophylaxis out of reach of those who need it most

By Scott Morgan

Pre-exposure prophylaxis (PrEP) is the use of antiretroviral medication to prevent HIV acquisition. The U.S. Food and Drug Administration has approved only one medication as PrEP, in July 2012: a co-formulation, of tenofovir disoproxil fumarate (TDF) with emtricitabine (FTC), manufactured by Gilead. While early uptake in the United States was decidedly slow, education and promotion have increased demand in some vulnerable communities. Yet around the globe, for the majority of people who need or desire PrEP as part of a complete prevention package, the medication is not affordable without regulatory approval and inclusion in national health programs.

The originator company, Gilead, has filed for regulatory approval for Truvada in only five additional countries (see table). In some countries, steps are being taken to include PrEP in national strategic plans and to issue guidance for health care providers, yet the onus remains on the originator or generic drug manufacturers to file for regulatory approval. And, depending on the country, the time from submission to approval can be over a year.

In South Africa, the first national PrEP guidelines for men who have sex with men at high risk for HIV infection were published in 2012. These guidelines are reportedly being updated to include populations beyond this group, yet the country’s regulatory agency, the Medicines Control Council (MCC), is not demonstrating urgency in approving PrEP. As South Africa has the highest HIV incidence globally, this snail’s pace has frustrated activists, clinicians, and scientists alike.

Without regulatory approval, there are still ways to get PrEP in some countries, particularly those hosting demonstration projects or open and enrolling PrEP trials. PrEP is also available off-label where TDF/FTC has been approved for treatment, such as the United Kingdom, at discounted—but still prohibitively expensive—prices. In Thailand, the Thai Red Cross AIDS Research Center provides PrEP for roughly US$1 per day; in Australia unregulated TDF/FTC can be purchased on the Internet for personal use at around US$313 for a 90-day supply. Yet, given the scope of the epidemic, it’s clear that these mechanisms are meeting the needs of only a fraction of people in high-risk groups. And they don’t include regular HIV testing and other necessary laboratory tests.

If we are to use all our evidence-based tools to eliminate new infections, there needs to be a coordinated effort among activists, manufacturers, and regulatory agencies to accelerate and streamline approval of PrEP so that individuals around the world can more fully control their sexual health.•

Truvada as PrEP: Select Global Regulatory Filings

Country Regulatory Filing Status Actions in Progress Notes


Filed April 2015 Discussions indicate a possible approval in mid-2016


Filed September 2014 PrEP is being evaluated by the Brazilian drug regulatory authority. No timeline has been published


Filed summer 2015 Québec has developed guidelines for health care providers


No filing Gilead is in discussions with the European Medicines Agency re: regulatory filing for PrEP Gilead has provided data for assessment in France for PrEP that could result in temporary access or expanded access programs


Pending The Kenya National AIDS Control Council has included PrEP in its HIV Prevention Revolution Road Map This is only a recognition that PrEP is needed, not a step toward regulatory approval

South Africa

Filed November 2013; queries issued Q1 2015 (addressed by Gilead) Both originator and generic manufacturers have submitted to the MCC and updated their submissions to include data from the IPERGAY and PROUD studies; however, the MCC has not indicated any specific timeline for review or approval Updates to the existing guidelines are in process; expansion to populations beyond men who have sex with men expected


Filed May 2014; queries issued Q3 2015 (addressed by Gilead)

United States

Approved July 2012 N/A Approved in July 2012 for prevention indication
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