PrEP Gains Ground in Europe as Region Awaits Generics

Marcia Frellick

October 27, 2016

GLASGOW, United Kingdom — Although only two countries in Europe — France and Norway — have implemented pre-exposure prophylaxis (PrEP) to prevent HIV infection, more are starting demonstration projects on the assumption that a generic version of emtricitabine/tenofovir disoproxil (Truvada, Gilead Sciences) will be available in the next 2 years.

Teymur Noori, from the European Centre for Disease Prevention and Control (ECDC) Surveillance and Response Support Unit in Stockholm, Sweden, told Medscape Medical News, "It's not about efficacy anymore, it's how do we implement this in countries?"

He pointed out to attendees at the HIV Drug Therapy 2016 conference here that the PROUD and IPERGAY studies of 2015 proved PrEP's effectiveness in preventing HIV infection.

The European Commission approved once-daily Truvada in August of this year, as reported in Medscape Medical News, but the drug faces regulatory hurdles in individual countries.

Now, countries have to figure out how to get it to the people most at risk for HIV. Noori said that Norway, which announced October 21 it would provide PrEP for free to high-risk patients, may inspire other countries to get ready for implementation, a process that can take years. Already, more than a dozen countries are actively pursuing demonstration projects, he said.

Three — Belgium, Italy, and the Netherlands — have started the demonstrations in healthcare settings.

"Generics companies are ready," he said. "They're just waiting until [Truvada] goes off-patent. Once it does, they will roll these out very quickly."

Sheena McCormack, MD, a clinical epidemiologist with Chelsea and Westminster Hospital in London, United Kingdom, and lead investigator on the PROUD study, said that in the United Kingdom, negotiations to reduce prices of Truvada have not been successful.

National budgets for prevention across Europe are infinitely smaller than the national budgets for treatment. Dr Sheena McCormack

"We've got a drug that's used for treatment and now is going to be used for prevention. National budgets for prevention across Europe are infinitely smaller than the national budgets for treatment," she said.

Differential pricing is one option, but she said those proposals have fallen flat.

"I think that's difficult for Gilead because they don't trust that hospitals can separate out the prescribing for the two different indications, and they're obviously concerned that a drug purchased for prevention will be used for treatment."

She said the United Kingdom could learn from other countries' successes in bargaining for lower drug prices.

"In Portugal, where they've managed to negotiate for treatment for hep C for everybody, that's going to cost the Portuguese taxpayers a hell of a lot of money, but they've obviously got a very good bargain from Gilead on the cost of drugs. So some states are able to cut these deals. We don't seem to be very good at it."

ECDC Prioritizing MSM

The ECDC is prioritizing the men who have sex with men (MSM) population in Europe in supporting access to PrEP because MSM transmission is the only mode of transmission that has shown an increase in HIV infection.

Noori notes that data reveal an increase of 42% over the last 10 years, and MSM made up 40% of all HIV cases in 2014.

Current efforts to reduce STI and HIV incidence among MSM in Europe are failing miserably. Teymur Noori

"Current efforts to reduce STI [sexually transmitted infection] and HIV incidence among MSM in Europe are failing miserably. STI trends are even worse than HIV trends," he said.

Wide delivery of PrEP will take the combined effort of policymakers, clinicians, community representatives, and public health experts, he said.

In US, Risk Gaps Are Wide

Keith Rawlings, MD, director of HIV medical affairs for Gilead Sciences in Foster City, California, said countries should look beyond targeting only MSM.

In the United States, for instance, where PrEP has been licensed since 2012, risk varies greatly by geography, sex, and race.

On the basis of Centers for Disease Control and Prevention estimates, he said, about 1.2 million people may benefit from PrEP in the United States, although not all would necessarily start use.

"While about 40% of those people are MSM, about the same proportion are actually women," he said.

Dr Rawlings described a significant racial and sex differentiation even within the MSM population. One in 2 black MSM in the United States have a lifetime risk of getting HIV, while 1 in 4 Hispanics and 1 in 11 white MSM have the same lifetime risk.

Geographically, over the past 20 years the states with the highest acquisition rates are in the South, a finding that has everything to do with race, he said.

Access to PrEP also varies by many of the same factors, he explained.

Most of those receiving Truvada in the United States are white. He said white males are more than six times as likely to receive PrEP as their black or Hispanic counterparts. White women are about four times as likely to start on PrEP as their black or Hispanic counterparts.

Addressing these gaps and finding subgroups of people who carry the most severe burden of HIV infection will be important for all countries, Dr Rawlings said.

Teymur Noori has disclosed no relevant financial relationships. Dr McCormack has received grants from Gilead Sciences, which has also provided medicine for her research. Dr Rawlings is employed by Gilead Sciences.

HIV Drug Therapy 2016. Presented October 26, 2016.

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