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Innovation The truth behind preventing HIV with PrEP By Yair Oded COPY URL

Ever since Truvada has been approved as pre-exposure prophylaxis (PrEP), meaning the use of antiviral drugs as a strategy for the prevention of HIV, it has gained increasing popularity across the globe—from the U.S. to Britain to Taiwan—and has been hailed as the ultimate method to combat the HIV epidemic and prevent new infections. For the past few years, criticism of the manufacturer and distributor of Truvada, Gilead Sciences, has remained relatively mild and did not slow down the surge of its products’ proliferation.

A recent lawsuit, however, filed by 41 Truvada patients who claim to have suffered damage to their kidneys and bones as a result of the drug, seeks to hold the California-based Gilead accountable and casts doubt over the company’s ability to continue its operations unimpeded.

The 41 plaintiffs, who come from 12 different states, have been using the Truvada either for HIV treatment in the form of tenofovir disoproxil fumarate (TDF) or as a preventative measure through the PrEP medication. All of them have sustained kidney damage and/or bone density loss upon sticking to a daily regimen of Truvada.

The lawsuit, launched by HIV Litigation Attorneys and funded by the AIDS Healthcare Foundation (AHF), was filed in the Superior Court of the State of California for the County of Los Angeles. On the firm’s website, HIV Litigation Attorneys declare they seek to hold Gilead accountable for its “failure to adequately warn about Truvada side effects, marketing a drug with design defects and stalling the development of a safer version of the HIV treatment in order to maximize profits”.

The severe and highly-dangerous side-effects associated with a fixed-dose administration of Truvada have been known to Gilead since 2001. Yet, while the company issued repeated warnings about Truvada’s side-effects in the EU, it omitted such information from its prescriber and patient labelling in the U.S. All the while, Gilead has been actively suppressing a safer alternative it developed to TDF, tenofovir alafenamide (TAF), in order to maximize profits off of TDF.

“We need to make sure pharmaceutical companies take patient health and safety into consideration in its business decisions”, Liza Brereton, attorney for the plaintiffs at HIV Litigation Attorneys and counsel for AHF, told Screen Shot, “You would think they always do this, but far too often, big pharma makes decisions to maximise profits over ensuring access to the best medications”.

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Gilead’s profiting off of Truvada has come under scrutiny long before the lawsuit was filed, particularly since the funding for its research relied on $50 million of taxpayers’ money. According to the Washington Post, in 2018 alone Gilead raked in $3 billion in sales from Truvada. Averaging at $1,600 to $2,000 a month if taken daily, Truvada remains unaffordable to a great number of Americans who are either uninsured or whose insurance plan does not cover the drug. Truvada’s prohibitive cost has meant it was least accessible to some members of the Black and Latinx queer community, despite the fact that the HIV epidemic concentrates primarily in their communities.

Commenting on the law firm’s agenda with its lawsuit, Brereton stated that, “In addition to fully compensating people who have been injured by Gilead’s decision to release the inferior TDF-drugs over the TAF-drugs, we would like Gilead to allow production of generics of its TAF-based drugs, which should have been released to the public years ago. Branded TAF is too expensive and Gilead should not be able to profit off this decision that hurt patient health”.

This begs the question—in lieu of safe medication available on the market, how can we continue to promote HIV prevention, both in our communities and on a large scale?

“Condoms are an effective way to promote HIV prevention and prevent the spread of STDs”, says Brereton, “ No HIV prevention drug prevents other STDs and no drug on the market is safe for long term consumption as a prevention mechanism. Keep in mind even Truvada as PrEP was approved by the FDA for use in combination with condoms”.

Brereton adds that “Gilead should have investigated and studied TAF as a preventative many years ago. They should get that done to see if it is effective as an HIV preventative because it is safer for patients’ kidneys and bones than TDF”. If we were to take a closer look, however, we would realise that the problem isn’t only Gilead’s unscrupulousness, but the fact that we look for a pill to solve an extremely complex and multi-layered issue.

There is no doubt that Gilead must be held accountable for its criminal and reckless behaviour—something that would hopefully set a precedent for other big-pharmas as well. Yet, in order to truly eviscerate the HIV epidemic, we must first address core issues such as systemic racism, queerphobia, economic disparities, and unequal access to quality education, housing, and healthcare.

It seems that by relying exclusively on medicinal solutions, we search for a quick fix for a problem that permeates all aspects of our society, one that would require extensive structural, social, and political overhauls to be rectified.