U.S. Task Force Finds “High Benefit” from Use of HIV Drugs for Prevention

Properly identifying patients at higher risk of transmission increases the benefits of prescribing certain HIV drugs as prophylactics, researchers determined.

New HIV drugs are particularly effective when used to prevent transmission of the disease, according to new guidelines that encourage use of the medications as prophylactics, even as some accuse the manufacturers of marketing less safe versions of the treatments for years in order to maximize profits.

The U.S. Preventative Services Task Force (USPSTF) issued a recommendation statement on August 22 in the Journal of the American Medical Association (JAMA), indicating its support for the use of HIV drugs like Truvada and Descovy as oral preexposure prophylaxix (PrEP) for those at higher risk of the sexually transmitted disease, saying such use carries “high benefits.”

However, the recommendation statement comes at a time when the manufacturer of those drugs, Gilead, faces a number of HIV drug lawsuits alleging that it withheld development of safer versions of the treatments for years, to maximize profits from the sale of older versions that were still under patent protections.

Gilead developed and manufactured Truvada, Viread, Atripla, Complera and Stribild, and promoted them as safe and effective HIV treatments, while creating an essential monopoly in the U.S. market. But a growing number of lawsuits by users of the drugs, known as tenofovir disoproxil fumarate (TDF)-based medications, claim the drugs carry a high risk of chronic kidney damage and bone fractures. Plaintiffs allege that the drug maker knew  were more toxic than they had to be, since Gilead was already aware of a safer alternative, using the HIV drug compound tenofovir alafenamide fumarate (TAF), know marketed as Descovy, which could be taken at lower doses and be equally as effective.

Rather than fully warning about the risk of bone demineralization, bone fractures and other kidney side effects, plaintiffs indicate Gilead continued to sell the older drugs without accurate risk information, and delayed development of the safer alternative, until patent protections expired, further extending its monopoly of the HIV treatment market.

The USPSTF conducted a review of currently available data to determine the benefits and harms of HIV drugs used for PrEP in order to make its latest recommendations, releasing an accompanying evidence report which determined there are significant benefits for prescribing TDF or TAF medications as prophylactics for those at a higher risk of contracting HIV through sexual activities.

The new data found that the newer TAF drugs, which plaintiffs say Gilead withheld from the market for years, are noninferior to TDF drugs, like Truvada. The task force last issued recommendations on PrEP use of HIV drugs in 2019, when there was only data on TDF drugs available.

“Compared with tenofovir disoproxil fumarate, tenofovir alafenamide fumarate achieves higher and more sustained intracellular drug levels at lower tenofovir serum levels, potentially increasing effectiveness and bone and kidney safety,” the researchers determined.

The researchers note that an important step in the process is identifying persons at high risk of HIV transmission, prescribing them the medications, and then following up with their care. When this is done, patients can see “high benefits” from using HIV drugs for PrEP, the researchers concluded.

They also looked at the risks of side effects, such as kidney and bone damage, and while some studies found TAF-based HIV drugs to be safer, some studies reviewed by the Task Force found no safety difference between the two types of medication.

The risk of the development of drug-resistant HIV through overuse was also examined, and the task force determined there are very few signs that this is a significant concern.

“The USPSTF concludes with high certainty that there is a substantial net benefit from the use of effective antiretroviral therapy to reduce the risk of acquisition of HIV in persons at increased risk of acquiring HIV,” the task force researchers concluded.

Gilead HIV Drug Lawsuits

According to allegations raised in Truvada lawsuits being pursued against Gilead, the drug maker withheld development of the safer versions of the drug to maximize profits that could be generated before patent protections expired, and the older TDF-based drug became available as a generic.

As the end of patent protections for the blockbuster drugs approached, allowing competition from generic equivalents for Truvada, Atripla, Stribild, Viread and other TDF-based drugs, the lawsuits allege Gilead began to introduce and aggressively market TAF-based versions of the medications, promoting their newer drugs as the safer alternatives to the toxic drugs they sold for years.

Given common questions of fact and law, the litigation is being coordinated in California state court during discovery and a series of early “bellwether” trials will be scheduled to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of claims.