Novel Developments: Merck & Gilead Partner on New ARVs

On March 15th, 2021, Merck and Gilead Sciences announced a partnership in development of their novel products, Islatravir and Lenacapavir – both currently in clinical trial phases. The partnership isn’t limited to these investigative products – both, if successful, would establish new classes of antiretrovirals each. The agreement allows an option by either manufacturer to investigate potential combination therapies with the other’s already established products. Additionally, while current trials for these medications are focused on oral administration and injectable application, Merck is investigating the potential for Islatravir as PrEP via an annual implant.

Let’s take a moment to acknowledge the remarkable nature of these proposed products. Gilead’s Lenacapavir is aimed at addressing those with multidrug resistance and – here’s the kicker – with a potential to be effective for as long as 6 months via subcutaneous injections. While Merck’s Islatravir has been described as “potent”, it’s so strong that in order for it to be taken once daily, it must be “lightly sprayed” onto a doravirine tablet (the partner medication for Islatrvir in current studies). Which is great for that aim at being a once weekly therapy.

With these two potential first-in-class medications inching closer to the finish line of approval, this partnership also stands to benefit advocates in a another direct way. Merck has been an exceptionally strong advocacy partner, edging into nuanced regulatory territories and working hard to ensure patients lead those discussions and the company’s positions. Gilead is savvy in their marketing, contracting, and programming; from flashy commercials on targeted tv platforms and innovative radio campaigns to the ease in which their products become “preferred” on some formularies to providing 10-day “sample” bottles – which some providers have used to initiate same day treatment for newly diagnosed people living with HIV without ever having to leave the provider’s office.

Merck and Gilead’s partnership here is…interesting to say the least. Prior to January 19, 2021, when the Supreme Court of the United States refused to hear Merck’s appeal, these two pharmaceutical behemoths were engaged in a legal fight over patent rights to hepatitis C medications, Harvoni and Sovaldi, since 2016.

When you work in HIV and Hepatitis patient advocacy, these kinds of things are our soap operas in their own way. We love our contacts within these companies and often share a great deal of our personal lives with them. That type of relationship is tinged, like most familial relationships, when we have conflicts of interest with our friends – where our priorities diverge from those of the corporation’s. The issue of patents and anti-competitive contracting are some of these hot button issues. All of that said, despite the faux-shock theatrics some advocates have used to enjoy the spotlight, our friends in pharmaceutical manufacturing are also some of the strongest supporters of our work (read: the largest share of corporate funding supporting advocacy).

Thankfully, the vast majority of these relationships are dynamic. Advocates enjoy space to call-out practices we find detrimental, direct funding to programs and priorities in alignment with our values, and provide feedback on nuanced areas like clinical designs and regulatory structures. One might say our greatest allies pay us to argue with them. And there’s good logic to such a scheme; a team grows stronger when the weaknesses are evaluated, addressed, and turned into strengths.

Indeed, this partnership, with its expansive nature to include development, manufacturing, and marketing, holds both great promise and great concern for our communities. Gilead is already learning from its failure with Descovy trials to include people assigned female at birth (AFAB) – including cisgender women in clinical trials for Lenacapavir as a long acting injectable (for both treatment and prevention) to begin later this year; though Gilead should note: “people of trans experience” won’t all fit neatly into the clinical trial including cisgender men. To be fair, Merck’s Gardasil commercials still refer to “males and females” rather than the simpler “everyone”.

Sincerely, the trans guy writing this blog.

Taken as a whole, this team poses the potential to be “The Dream Team” in both treatment and prevention and as partners to advocates. We’ll need to see the best of them, not the worst and we’ll need to keep a close eye on how those relationships we’ve come to rely upon may change in light of this new partnership.

In the meantime, (I’m going to say this for the first time a year with a humorous intent rather than a morbid one) pass the popcorn. This season is going to be fantastic!