Gilead Sciences has been no stranger to controversy as consumer groups have knocked the drugmaker’s alleged profiteering with its HIV/AIDS meds portfolio. Citing those concerns, one group is calling on Gilead to drastically cut the cost of next-gen med Descovy in its new indication.
On Friday, the AIDS Healthcare Foundation (AHF) called on Gilead to “do the right thing now” and drop Descovy’s list price following its FDA approval last week as a pre-exposure (PrEP) HIV treatment for homosexual men and transgender women.
The group cited the “countless billions” Gilead has made off its HIV/AIDS drugs in the request, as well as allegations the drugmaker kept newer tenofovir alafenamide (TAF)-based meds—including Descovy—off shelves to keep hawking those made with tenofovir disoproxil fumarate (TDF), which has been tied to kidney and bone damage.
“Gilead must atone for its deliberate suppression of TAF from patients over the past decade or more simply in order to maximize its profits and extend sales of its more harmful TDF-based medications,” AHF President Michael Weinstein said in a release. “As a result, people have been grievously harmed—many, suffering permanent kidney and bone damage—by Gilead’s greed and pursuit of the almighty dollar.”
A Gilead spokesperson could not be reached for comment by press time.
Back in August, when an FDA advisory committee recommended Descovy for PrEP approval, AHF made the bold request that Gilead drop the drug’s cost to $1 per pill. Descovy currently lists at around $1,800 for 30 tablets—or around $60 per pill, according to Drugs.com.
In its Friday request, AHF dropped the specific price request and asked Gilead only to “significantly cut” the drug’s cost.
Descovy has been at the center of lawsuits targeting Gilead’s alleged campaign to actively suppress its TAF-based drug portfolio in favor of drugs the company knew led to bone and kidney damage in patients.
In May, a federal judge hit the green light on a class-action suit involving 140 patients in 31 states accusing Gilead of leveraging its next-gen HIV/AIDS meds’ safety profiles to switch patients off its older drugs.
Gilead’s TDF meds Viread, Truvada, Atripla, Complera and Stribild won FDA approvals in 2001, 2004, 2006, 2011 and 2012, respectively. The safer TAF meds hit the market beginning with Genvoya in 2015, followed by Odefsey and Descovy in 2016.
When it launched the newer suite of meds, Gilead touted TAF's safety—particularly its lower risks of kidney and bone toxicities—to convince doctors to move patients to the next-gen products. Its switching campaign depended on "the very benefits that Gilead could have and should have incorporated into its prior product designs but withheld from doctors and patients for over a decade,” the lawsuit claimed.
That campaign to switch patients onto its newer meds has escalated recently as Gilead’s Truvada faces an onslaught of generic competition in September 2020.
Descovy’s relatively tame safety warnings compared with Truvada's—including a better profile in bone and kidney toxicities—“should provide sufficient ammunition for Gilead to drive substantial switching from Truvada in men,” SVB Leerink’s Geoffrey Porges wrote in a Thursday note to clients. Descovy also demonstrated more rapid onset and maintained drug concentration longer than Truvada.
It’s not all great news when it comes to safety, though: The FDA threw a renal impairment warning on Descovy’s label on approval in 2016. Also, the drug isn’t approved for PrEP in cisgender women, although Porges said only about 10% of PrEP patients are female.