Curing Hep C Gets Easier But More Expensive

For people with the hepatitis C virus — many of whom have HIV as well — it’s been a year of change and challenge, with a new breakthrough drug pushing a previous one out of the headlines, but bringing with it issues of how to pay for the treatment.

Harvoni, a combination med from Gilead Sciences, is this year’s big news on the HCV front. It’s become more popular than Gilead’s Sovaldi, hailed last year as a groundbreaking new treatment for the virus, but it’s even more expensive.

Harvoni, approved by the Food and Drug Administration in October 2014, combines Sovaldi (generic name sofosbuvir) with another drug, ledispavir. Unlike Sovaldi and other HCV meds, it does not have to be taken with other drugs, such as ribivarin or peginterferon alfa.

That makes Harvoni a super simple treatment, just one pill a day, and in studies it’s shown a 95 percent cure rate, even better than Sovaldi’s 90 percent. The combination of simplicity and efficacy has led to great demand.

“People are coming in who never wanted to be treated before,” Dr. Douglas Dieterich, director of outpatient liver disease treatment at Mount Sinai Hospital in New York City, told the Associated Press. “When I started in 1989, I used to have a 3 percent cure rate. Now I have a 3 percent failure rate.”

That’s great news for people with HCV. An estimated one-quarter of all people with HIV also have HCV, as do more than half of injection drug users who are HIV-positive. A person can carry HCV for years without symptoms, but if untreated it can cause cirrhosis of the liver, cancer, and other life-threatening complications. Today it’s the leading chronic viral infection leading to death in the United States, overtaking HIV in 2007 for that distinction.

Patients and doctors quickly embraced Harvoni; in the first quarter of 2015, it made up three-fourths of the prescriptions filled for HCV drugs, according to IMS Health, a company that tracks prescription drug sales. Its sales surged as Sovaldi’s dropped.

Another new, equally effective HCV treatment is AbbVie’s Viekira Pak — ombitasvir, paritaprevir, and ritonavir tablets packaged with dasabuvir tablets. It was also approved by the FDA in late 2014; it has been gaining in popularity, according to news reports, although this is hard to quantify as the drugmaker didn’t divulge Viekira Pak sales to IMS. The fact that it’s not a single-tablet regimen may cut into its popularity.

Both Harvoni and Viekira Pak come highly recommended by professional associations. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America issued joint guidelines for HCV treatment this year, saying all patients should receive one of these two new drugs, with older ones “not medically recommended.”

But cost is an issue. Before discounts, Harvoni retails for about $94,000 for a 12-week regimen (compared with $84,000 for Sovaldi) and Viekira Pak about $83,000. Many patients are cleared of the virus in 12 weeks, although some require 24 weeks of treatment.
 
The price has some insurers and government officials alarmed, but state Medicaid programs are entitled to deep discounts, and some private insurers have negotiated them as well. Also, drugmakers say the price will drop as pent-up demand for effective HCV treatment is met, and note that HCV, unlike HIV, doesn’t require lifelong treatment.

 Still, the cost has led some states to establish guidelines for who gets treated; for instance, California’s Medi-Cal program, for low-income people without private insurance, will offer treatment only if a test shows heightened scarring of the liver. Some doctors say delaying treatment this long won’t increase the chance of illness or death. But waiting until there are more serious complications is not recommended.

Ultimately, some health care activists say, the federal government may need to regulate drug prices. “As a society we need a way of determining what is a reasonable price at the time of introduction of a new drug,” Stephen Schondelmeyer, a University of Minnesota professor focusing on pharmaceutical economics, told the AP. “We have expanded coverage, but we haven’t done anything to control costs on the pricing side.”