Pandemic Era Tests May Speed Hepatitis-C Detection

The Monday after Christmas, when Kellie Trent was scheduled to pick up medication to cure her hepatitis C, it seemed like a little miracle.

She was expected at the Pioneer Family Practice in western Washington State, seven months after screening positive for the blood-borne infection at a clinic that dispenses medication to treat her heroin addiction. All that time, as she underwent more tests and waited for results while in and out of residential drug treatment, addressing her hepatitis C remained out of reach.

On the eve of her December appointment, her physician, Dr. Lucinda Grande, grew concerned when a storm brought four inches of snow to the region, snarling the roads.

But in the end, Ms. Trent did not show up because she landed in jail for a few days, arrested after missing court appearances for sentencing on a misdemeanor assault charge, according to court records.

Dr. Grande stowed away the first half of the unused prescription — a four-week course of pills priced at $13,000.

“She has had a bumpy road,” Dr. Grande said.

Ms. Trent is among an estimated 2.4 million Americans with hepatitis C, which killed more than 14,000 in 2019, the most recent data available, despite the availability of drugs offering a relatively straightforward cure. The U.S. government set a target of largely vanquishing the disease by 2030, but data from the Centers for Disease Control and Prevention show the number of treated patients has been falling and is less than half the rate necessary to meet that goal.

Progress has been further eroded by an explosion of new infections, driven by injection drug use among 20- and 30-year-olds, according to data from the C.D.C.

The pandemic has exacerbated the challenge. Three-quarters of surveyed state viral hepatitis programs reported losing staff and cutting preventive services. Laboratory and prescription drug data show a sharp decline in hepatitis C diagnosis and treatment in 2020.

Experts say the country needs to make it easier for those diagnosed to begin treatment the same day. Automated molecular tests capable of use at the point of care, similar to ones that have become ubiquitous 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 and several other health technology companies, 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.

Ms. Trent has had a lot on her plate. She’s intermittently homeless, and despite several chronic illnesses, she has had sporadic contact with health care providers. She recalled being revived from near-fatal drug overdoses nine times during her decades-long struggle with addiction. “I’m 48 going on 88,” she said in an interview in mid-December.

This complex set of problems also makes her typical of a large part of the U.S. population with hepatitis C. Since 2014, when a new generation of drugs provided an effective cure with few side effects, more than 840,000 people have received treatment, overcoming high prices set by drugmakers and restrictions imposed by state governments and insurers. That has left chronic hepatitis C infections concentrated in a group of people more likely to be seen in prisons and at syringe exchanges than in traditional hospitals and clinics.

Dr. Grande said hepatitis C is common among her patients who inject drugs. But curing those patients is not straightforward, even in Washington State, which has dropped all restrictions on access to medications and waived the need to get insurers’ prior authorization.

Last spring, when Ms. Trent first screened positive for previous exposure to hepatitis C on a finger-stick test, there was no phlebotomist at the clinic to draw blood for confirmation that she had a chronic infection, so she was referred to an outside lab. She didn’t make it there until August, and awaiting those results added another delay. Then, in October, Ms. Trent missed an appointment because she was in a drug treatment facility. And without a driver’s license, she constantly struggled to arrange transportation.

“Once somebody manages to make it in the door at our place, that’s a major accomplishment,” Dr. Grande said. 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.”

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. Cue Health, which is the official test provider of the N.B.A. and has sold more than 120,000 testing platforms, reported that annual revenue grew 25-fold to more than $600 million during the pandemic. Ayub Khattak, the company’s co-founder, said the streamlined regulatory process was transformative: “It just broke open the door.”

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, an approach known as “test and treat.” Patients may then be less likely to transmit the disease to others, and more likely to complete treatment and be cured.

One of the most promising hepatitis C tests was created by Cepheid, a diagnostic company based in California. With a palm-size cartridge preloaded with chemical reagents, the test runs on the company’s proprietary GeneXpert machine and can confirm the presence of a suspected pathogen in less than an hour. Because of its simplicity and size — the whole unit is the size of a desktop printer — it can be deployed at remote sites and can be operated by staff members with minimal medical training.

Research on how a rapid diagnosis affects patients’ hepatitis C treatment is limited. In a pair of pilot studies where the technology was taken to a syringe exchange and a prison, more than two-thirds of diagnosed patients began treatment, perhaps double the share of those who started therapy under typical conditions. Both studies received funding from drugmakers and in-kind support from Cepheid.

Jason Grebely, one of the investigators leading the study and a professor at the Kirby Institute, a medical research organization in Sydney, Australia, said the technology “is probably the next game-changer” in the field of treatment for hepatitis C. Dr. Grebely previously received research funding from Cepheid and various pharmaceutical companies.

In the United States, where there were 5,000 GeneXpert machines as of March 2020, the company’s recent focus has been on Covid — it expected to sell 55 million coronavirus tests in 2021 — but its hepatitis C tests are in use abroad. European regulators approved Cepheid’s hepatitis C test in 2018, and France and the United Kingdom have each deployed dozens of GeneXpert machines to support efforts to eliminate hepatitis C.

Australia is the latest country to embrace the approach. In September, its government announced a $6.5 million program to equip 65 sites with GeneXpert machines by late 2022 with the goal of screening 50,000 to 60,000 people.

One of the units is already aboard the mobile Kombi Clinic, which a group of clinicians in Queensland run out of a canary yellow, 1975 Volkswagen van. Dr. Joss O’Loan, a general practitioner and one of the clinic’s founders, described how a nurse drove the van to places with a likely high prevalence of hepatitis C and then provided testing. At one homeless drop-in center, a nurse set up next to a person giving haircuts, and at a recent music festival, positioned the clinic between a crystal healer and a tattoo artist.

The mobile clinic is also equipped with a device to assess liver function, and about half of the patients diagnosed with the disease begin taking medications the same day. Even if a patient would benefit from follow-up tests, the clinicians prefer to start treatment immediately and adjust the prescription once further results come in.

“This isn’t the silver bullet that will transform the whole environment,” Dr. O’Loan said, “but it’s going to go a long way for a lot of people.”

American clinicians have expressed interest in a similar approach, but F.D.A. approval of automated molecular tests for hepatitis C could still take years. Advocates, who noted that Cepheid developed the GeneXpert with more than $252 million in grants, tax credits and other government investments, said the company, now a subsidiary of the conglomerate Danaher, owed it to the public to submit its hepatitis C test for approval. “This is a whole class of technologies that could have a lot of potential for hepatitis C that are just completely stalled on the regulatory side,” said Annette Gaudino, director of policy strategy at the Treatment Action Group.

In November, the F.D.A. lowered the hurdle by reclassifying hepatitis C diagnostics as medical devices that require less scrutiny. Asked whether Cepheid would consider submitting its test to the F.D.A. for review, Darwa Peterson, a company spokeswoman, said that it was “assessing the path forward.”

Some U.S. clinics noted that even with the advent of automated molecular tests, other barriers would remain. Marguerite Beiser, who directs hepatitis C services for the Boston Health Care for the Homeless Program, said mobile technologies would be needed to substitute for follow-up blood- and liver-tests required to begin patients on medications. Massachusetts would need to drop the requirement that patients get prior authorization from their health insurer before initiating treatment, too.

But the status quo is dire. “We are so far behind and we’re losing ground,” Ms. Beiser said of the country’s efforts. “We need to be flexible and use every single tool we have to get it done.”