Gilead has lost court proceedings that would extend the pharmaceutical company’s patent for Truvada, the anti-HIV medication approved for use as pre-exposure prophylaxis (PrEP) in the UK and US, but not in Ireland.

The patent for Truvada expired in July of this year, however, Gilead promptly sought to extend its exclusivity as the sole supplier of the drug in Ireland on the basis of the supplementary protection certificate (SPC) it holds in Ireland until 2020.

Gilead did not comment on the High Court judgement.

Act Up Dublin member Andrew Leavitt welcomed the decision by Justice Brian McGovern, indicating that it could “accelerate the timeline” for HSE funded PrEP since generic Truvada is significantly cheaper than Gilead’s offering.

Money Maker

With rival pricing coming in as much as 60% cheaper, such an injunction against sourcing generic Truvada from Gilead competitors Mylan and Teva would have cost the government millions.

Heralded by The Irish Times as a “blockbuster HIV drug”, Truvada has earned Gilead over $14 billion in recent times.

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The HSE currently spends €24 million sourcing Truvada from Gilead to treat HIV and for use as post-exposure prophylaxis (PEP), but not for use as PrEP.

PEP can be taken up to 72 hours after potential exposure to HIV to prevent someone from acquiring the virus, while PrEP is a daily medication which reduces the risk of contracting HIV by up to 90%.

Irish Times sources indicate that with Gilead’s injunction now rejected by the court, generic forms of Truvada from Mylan and Teva are “imminent”.

PrEP Availability

PrEP is readily available in the UK via online purchasing and an NHS run clinical trial, contributing to a 42% drop in HIV diagnoses in London’s 56 Dean Street clinic since 2015.

In the US, PrEP is covered by many health insurance providers making it attainable for many men who have sex with men (MSM).

Today in Ireland, however, the situation surrounding sourcing PrEP is fraught with uncertainty, leaving Ireland’s MSM community lacking a vital HIV prevention tool.

Silence

Minister for Health Simon Harris continues to remain silent on the issue, which sexual health advocate Adam Shanley condemned as “an indictment to his position” on the topic and of the health of MSM.

To contextualise Harris’ silence, HIV diagnoses in Ireland are at an all-time high, with MSM counting for more than 50% of all HIV diagnoses in 2016.

With no official stance on PrEP availability taken, MSM in Ireland had taken to purchasing the drug online at a cost of about €34 per month, a tenth of the price it costs to source in Ireland.

Since the summer, however, Ireland’s Health Products Regulatory Authority (HPRA) and Irish customs have blocked people from importing generic Truvada that had been sourced online, leaving MSM without access to the drug.

“We don’t care who the HSE acquires PrEP from, we just want it available in Ireland,” Leavitt said.

With PrEP in Ireland imminent, do you think we’ll be seeing HSE-funded access to the drug before the end of 2017?