A Cure with a Catch
Interferon, for all its harrowing side effects, is not that effective. Overall, 50 percent of people are not cured (and 75 percent are not cured when coinfected with HIV), even if they complete the entire course of treatment.
And then last year, there was what Taylor calls “an extreme revolution” in how to cure hep C.
New drugs called direct-acting antiviral agents (DAAs) came to market. One, Sofosbuvir, inhibits the virus’s polymerase enzyme, which builds new genomes out of RNA so the virus can replicate. Sofosbuvir looks like a building block of RNA, but once it is incorporated into the RNA chain, the chain cannot grow and the virus cannot reproduce. Even better, DAAs can be used without interferon.
Taylor had her patients prioritized by severity of liver disease to get the drugs as soon as the FDA approved them in December 2013. “I don’t text, and I don’t typically interact directly with pharmaceutical companies, but I made an exception for this,” she says. “I told Gilead [Pharmaceuticals], you text me the day the FDA approval comes through, because these patients are waiting and waiting, and people are going to die waiting.”
On the new drugs, patients feel better. After two weeks, their hepatitis C viral load is zero. Though Taylor cautions that the drugs are new and it will be years before we know if there are long-term complications, they seem to be extremely safe, with virtually no side effects. A year (or more) of interferon has turned into a 12-week course of therapy. And the cure rate? Nearly 100 percent.
But there’s a catch. The pills are expensive— at least $84,000 (more for patients requiring longer-duration therapy) for the full course of treatment. Private insurance companies usually cover the drugs, but only after a few denials. Taylor says she’s always writing letters and calling insurance companies explaining why patients need the newer drugs instead of interferon. Until September 2014, Rhode Island’s Medicaid program would not pay for the drugs at all—one of only three states that refused to do so. The state finally issued a policy requiring pre-authorization, which documents why the drug is needed, how advanced the patient’s liver disease is, and the fact that the patient cannot tolerate other treatments.
Medicaid decision makers say they are trying to make prudent policies for drugs that are still very new and expensive. Their arguments are familiar: will people with addiction take the pills faithfully, important since strict adherence to the regimen is necessary to effect a cure? And if they continue to inject drugs, will they get reinfected?
Most of Taylor’s patients are on Medicaid, and the math seems painfully obvious to her given that hep C is now the leading cause of liver transplants and a leading cause of liver cancer. Total billed charges in 2011 for a liver transplant were $577,100. If Medicaid is burdened now and can’t pay $84,000 for pills, she asks, how can it sustain an increasing incidence of end-stage liver disease and the exorbitant expenses of end-of-life care?
The problem is not just Medicaid’s. It’s soon to be Medicare’s, too.
“The enemy of this virus is time. You’re not going to feel anything the first week you got it; you have no idea that you have it. Many people infected in the past are now developing full liver scarring and liver cancer, and our liver cancer rates are soaring,” Taylor says.
Most vulnerable are the baby boomers, people born between 1945 and 1965. Screening the blood supply for hep C only began in 1992, so people may have been infected through blood transfusions or iatrogenically in health care settings. According to the Centers for Disease Control and Prevention, 75 percent of the estimated 3.2 million people with hep C in the US are baby boomers. That fact led the CDC to issue new guidelines for screening for hep C in all people born in that era, regardless of risk factors.