An estimated 2.4 million Americans have hepatitis C, and in 2019 more than 14,000 people in the United States died from it despite the availability of drugs offering a relatively straightforward cure.
The U.S. government set a target of largely vanquishing the disease by 2030, yet data from the Centers for Disease Control and Prevention show it is struggling to meet it.
The pandemic has aggravated the challenge — three-quarters of surveyed state viral hepatitis programs reported losing staff members and cutting preventive services. But it has also ushered in a wave of diagnostics that could help the fight.
Experts say the country needs to make it easier for those diagnosed to begin treatment the same day. And automated molecular tests capable of use at the point of care, similar to ones used for diagnosing Covid, could be crucial for doing so.
Dr. Scott Gottlieb, a former commissioner of the Food and Drug Administration who sits on the board of Pfizer, recently described the advent of these diagnostics as “one of the most enduring technological innovations” stemming from the pandemic. Such hepatitis C tests are already in use abroad, but no device makers have submitted one to the F.D.A. for approval.
For many patients, navigating a complex pathway to treatment, entailing multiple return visits over a period of weeks or months, can prove insurmountable. “It’s just a big barrier,” said Dr. Lucinda Grande, a physician.
Automated molecular tests could compress this process. From a small sample of blood or saliva, the tests amplify any trace of viral genetic material in a process akin to the older laboratory-based method of polymerase chain reaction (or P.C.R.), but have been miniaturized to run on small machines. The technologies have been around for years but gained greater visibility during the pandemic, when the F.D.A. allowed many test developers to leapfrog what is traditionally a lengthy approval process.
Companies that have developed coronavirus tests of this ilk have seen enormous growth, and a similar molecular test for hepatitis C could allow clinicians to deliver a diagnosis immediately and perhaps start many patients on medications the same day. Patients may then be less likely to transmit the disease to others, and more likely to complete treatment and be cured.
