LOS ANGELES: Gilead Sciences hopes to soon introduce a pricey new pill to prevent HIV in people at risk of contracting the infection, but the drugmaker faces opposition from an unusual source: patient advocates.
Such groups have traditionally lobbied for insurance coverage of newer HIV drugs regardless of expense.
But at least three U.S. organizations now question whether Gilead’s Descovy would be the best option for most people at risk of exposure.
A generic version of the current prevention pill, Truvada, is due in the United States next September, which should bring down costs and give many more people access to the therapy, they say.
Their resistance is being echoed by some insurers, including the pharmacy benefit arm of Cigna Inc, which are hinting that price will be a barrier to providing coverage for Descovy.
“Based on the science that we have seen thus far, there is no indication that everyone needs to be taking Descovy,” Tim Horn, director of medication access and pricing at the National Alliance of State and Territorial AIDS Directors (NASTAD) told Reuters.
“We see no reason to push back against commercial payers or Medicaid programs that would move to prefer generic Truvada (for prevention), provided there are guard-rails that do not deny access to Descovy for those who need Descovy,” he said.
Truvada, also made by Gilead, has been used to treat people infected with HIV since 2004. It was approved as a daily pill for pre-exposure prophylaxis, or PrEP, in 2012, and remains the only preventive therapy on the U.S. market.
Descovy, shown to be less toxic than Truvada to the kidneys and bones in clinical trials, was approved in 2016 for people already infected with HIV. Advisors to the U.S. Food and Drug Administration will meet on Wednesday to decide whether to recommend Descovy for PrEP, with agency approval widely expected before the end of the year.
When asked about the patient groups’ criticism, Gilead said Descovy is safer than Truvada and offers more efficient delivery of its antiviral component, resulting in greater concentration of the drug in cells where HIV infection can occur.
The Centers for Disease Control and Prevention estimates that 1.1 million people in the United States could benefit from PrEP.
Gilead said 213,000 people were taking Truvada for HIV prevention in the second quarter of this year.
The company has pledged to help the Trump administration achieve a goal of stopping the spread of HIV in the United States within a decade. In May, Gilead said it would donate enough Truvada annually to supply 200,000 uninsured Americans with PrEP until Descovy is approved for HIV prevention, then switch patients to the new drug.
