Four years ago, the first curative pills for hepatitis C virus (HCV) were handed to patients. These drugs were a breakthrough for people infected with this pathogen. Lacking in serious side effects and eradicating the virus from the body in just 12 weeks, these so-called direct-acting antivirals (DAAs) offered a clean escape from this potentially fatal liver illness.
But with numerous DAAs now available—along with their long trail of clinical trial data—primary care physicians are left to navigate a crowded and confusing landscape for treating HCV. Controversy surrounding the cost of these drugs has also become a concern.
As a result, doctors may be hesitant to treat patients directly, preferring instead to refer them to liver specialists or delay treatment until symptoms arise, which could be several years after the infection is diagnosed. "Many primary care physicians are still too unfamiliar with the regimens to speak with confidence about them," says hepatologist Ira Jacobson, who leads the department of medicine at Mount Sinai Beth Israel Hospital in New York.
The reluctance may trace back to the pre-DAA era: Hepatitis C treatment rates have historically stood at 30 percent or lower, in part due to physicians' concerns about the side effects of earlier medications, a lack of awareness about hepatitis C, and a tendency to refer patients with the infection to a liver specialist instead of treating them directly.
A new, exhaustive examination of the DAA data should persuade general practitioners to embrace the care of hepatitis C. Up to 5 million Americans living with the disease, an estimated 140 million people infected worldwide, and the numbers are still climbing. Embracing these curative treatments could be crucial to ending the HCV epidemic.
The report, published this week in Annals of Internal Medicine, examined data from 42 clinical trials of 10 DAAs in all of the six major genetic variations of HCV. Three of these studies compared two regimens: an experimental drug or combination versus the prior standard treatment. The remainder were studies of new drugs without a comparison, a less scientifically rigorous approach than a two-arm study. The authors, led by Oluwaseun Falade-Nwulia, infectious disease specialist at Johns Hopkins University, did not include early-stage studies searching for the best dose of a drug or gauging its safety.
All but one of the 42 studies were funded by industry sponsors, which could tilt the interpretation of the results in the drug's favor. The study authors found that 19 of the studies had a low risk of bias and 23 had a moderate risk. The studies investigated the capacity for the new medications to elicit a so-called sustained virologic response, or SVR—in other words, no virus in the body. All of the regimens put under the statistical microscope excluded interferon, the notoriously harsh drug that was, until a few years ago, the only option for treating hepatitis C.
According to the comprehensive scrutiny, all of the DAA regimens approved by the U.S. Food and Drug Administration for the treatment of HCV had high virologic response rates. Fewer than 10 percent of the patients in all 42 studies had problematic side effects and fewer than 5 percent abandoned treatment. "This group of medicines is really good news," says Mohga Kamal-Yanni, a senior health adviser with the nonprofit aid organization OXFAM.
Not all HCV patients benefited equally, though. For example, patients with the variety known as genotype 1 had the most treatment options. But those with genotype 3—the second most prevalent type of HCV worldwide—have fewer treatments available. "That's a little worrying," says Kamal-Yanni. And patients with more advanced disease were not cured as often as earlier-stage patients.
But understanding the benefits of the new drugs is not enough to clear all the hurdles to care. "We have really good treatments that can have a positive impact," says Falade-Nwulia. "Now the major barrier is access." The high cost of DAAs, controversial when they first emerged, remains problematic. "The drugs are horrendously expensive," she says. Even after manufacturers cut prices of their DAAs for countries with an especially high prevalence of hepatitis C, such as Egypt, India and Mongolia, they are still out of reach for many people, says Kamal-Yanni.
The population of people living with undiagnosed hepatitis C is another issue. Both the U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention recommend that everyone born between 1945 and 1965—the baby boomers, which account for two-thirds of the HCV population—be tested for the virus. "There's been some uptake of that recommendation," says Jacobson, "but it's not sufficient."
As Jacobson sees it, however, the more physicians understand treatment, the more likely even the undiagnosed are to benefit. "Anything that makes primary care physicians aware of the opportunity for cure afforded by these drugs," says Jacobson, "will lead to an elevated consciousness about screening for hepatitis C."
For Falade-Nwulia, the study is also an opportunity to take account of mileage made in the treatment of this dangerous illness. "We have multiple options, these options are safe and they work well in many different patients," she says. "We've come a long way."
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