New HIV Prevention Shot Appears Safer Than Truvada For Women, and More Effective

The findings of recent clinical trials suggest the long-acting injectable HIV drug cabotegravir may be more effective and safer for women at preventing HIV than Gilead’s Truvada, which has been the go-to daily medication for pre-exposure prophylaxis (PreP).

On November 9, ViiV Healthcare, a subsidiary of GlaxoSmithKline, issued a press release indicating that an independent data safety monitoring board has determined that cabotegravir, which is given every two months, is 89% more effective at preventing HIV in women than Truvada.

The announcement follows earlier reports that the HIV prevention injection was more effective in men as well, and ViiV indicates the data shows it is safer than Truvada among both genders.

“Women need more effective choices for HIV prevention. If approved, long-acting cabotegravir will provide an option that reduces the number of annual dosing days from 365 to six,” Dr. Kimberly Smith, ViiV’s head of research and development, said in the press release. “In addition, long-acting cabotegravir can be discretely administered and may empower women to reduce their risk of HIV acquisition without the need for negotiation with their sexual partner.”

The current standard PreP drug for HIV prevention is Gilead’s Truvada (emtricitabine and tenofovir disproxil fumarate); a pill taken daily. It is a member of a family of HIV drugs based off tenofovir disproxil fumarate (TDF) and a combination of other anti-viral medications. All are Gilead drugs, including Truvada, Viread, Atripla, Complera, and Stribild.

The potential competition comes as Gilead faces an increasing number of lawsuits over all of TDF-based HIV drugs, which allege that the drug maker has known for years that a less toxic version of the medications could be developed, involving the antiviral tenofovir alafenamide fumarate (TAF). However, rather than warning consumers, Gilead continued to aggressively market Truvada and other TDF-based drugs until patent protection expired.

It was after the blockbuster drugs were about to face competition from generic TDF equivalents that the drug maker introduced TAF-based drugs, marketing them as safer than the toxic TDF-drugs they had sold for years without adequate warnings for consumers.

Most of the lawsuits have been filed by plaintiffs who say they unnecessarily suffered Gilead HIV drug side effects because of Gilead’s actions. Most of the complaints are currently pending in California state court, but a number have also been filed in various federal district courts nationwide over the past year.