The medical roller coaster of Hepatitis C treatment

October 6, 2014

PITTSBURGH ó Barbara Walter has experienced the full medical odyssey of chronic hepatitis C infection, having faced its every major challenge while benefiting from all of the modern breakthrough treatments.

She is one of the lucky few. She is cured, with no detectable virus in her blood since July.

But it is a medical roller-coaster ride for the 4 million Americans and 180 million people worldwide with hepatitis C.

The latest issue involves two new antiviral medications that can cure a patient in 12 weeks and one expected soon to be available once the U.S. Food and Drug Administration finalizes approval. But those breakthroughs are tempered by the drugsí price of $1,000 a pill, limiting their use to only those with the severest complications or biggest bank accounts.

A 12-week treatment regimen with one of two drugs costs $60,000 and $80,000 respectively, with a full regimen of both drugs costing $144,000, which is a prohibitive cost for public and private health plans for most people with the disease.

The major step forward in treating the infection must be weighed against the drugsí costs that pose a "potential threat to the viability of the U.S. health-care system," states proposed guidelines for use of the drugs outlined last week in the Journal of the American Medical Association. The controversy involves the drugs sofosbuvir (sold as Sovaldi) and simeprevir (sold as Olysio), often prescribed along with other drugs. A single-drug regimen awaiting FDA approval could cure the disease in as little as eight weeks.

Gilead Sciences Inc., the manufacturer of sofosbuvir, raised the bar of controversy recently with its announcement that it would license generic versions of sofosbuvir to be manufactured by various drug companies to be sold for a fraction of the American price in India and 90 other nations whose citizens cannot afford full-market price. A full round of treatment in India could cost less than $1,800, about a penny on the dollar when compared with the American price.

One in 100 Americans has hepatitis C, with 80 percent of the cases infecting baby boomers. Many contracted the disease decades ago when blood transfusions were not screened for the virus. The infection also can be transmitted through intravenous drug use and sexual transmission.

The National Medical Association says of every 100 people with the infection, 75 percent to 85 percent develop chronic hepatitis, with 60 percent to 70 percent of those developing chronic liver disease. As many as 20 will develop cirrhosis of the liver (liver scarring), and as many as five will die from cirrhosis or liver failure..

Walter, 67, of Fairview, Pa., received a blood transfusion in 1976 during a medical procedure. This eventually led to her diagnosis of hepatitis C in 2000 after a routine blood test. Most people with the virus often donít know they have it until they begin experiencing the symptoms of cirrhosis or liver cancer.

"Actually, I felt good," she said. "A lot of patients get discoloration, but I wasnít yellow. I did not lose weight. I really looked healthy."

Soon after diagnosis, she was placed on the traditional course of peginterferon and ribavirin, which requires about a year of treatment to produce a cure about 50 percent of the time but with adverse side effects. The drugs did not work for Walter, and the side effects required medication.

But back pain in December 2011 led to discovery of a cancerous liver tumor, which University of Pittsburgh Medical Center physicians removed. That led to her being listed for a liver transplant due to advancing cirrhosis. She underwent a successful transplant in April 2013 at UPMC Montefiore. Then, last April, the liver began showing signs of rejection once hepatitis had infected the new liver.

So she received insurance approval for the expensive dual-drug combination of sofosbuvir and simeprevir, which she took May through July, with a $10,000 copay and a total medication cost of $144,000, she said. And it worked. Since her blood test in July, she has had no signs of infection.

"If you already went through a transplant, you donít want anything to happen to the new liver," Walter said. "Life depends on it. So my husband said, ĎWhatever the cost, itís worth it.í"

The liver is the bodyís largest organ, with more than 500 functions, said Vinod K. Rustgi, the UPMC medical director of liver transplantation.

The U.S. Centers for Disease Control now recommends people born between 1945 and 1965 be screened with a blood test for the hepatitis C infection. Symptoms donít typically appear until liver function declines to less than 30 percent, with typical symptoms of jaundice, a swollen abdomen, confusion and bleeding, Dr. Rustgi said. People who reach this stage of infection face a 50 percent death rate within five years, which points to the need for drug treatments and liver transplants.

In 2007, the death rate from hepatitis C began exceeding that of human immunodeficiency virus infections in the United States. "HIV has received a lot of publicity, and it is incumbent upon us to make people aware that hepatitis C is more common than HIV and it is curable."

Screening allows for earlier recognition of symptoms and allows for lifestyle changes, including dietary changes and abstinence from alcohol, Dr. Rustgi said.

"When you look at an area like Pittsburgh, where there are 2.4 million people (in the metropolitan area), we may have 50,000 people with hepatitis C, with only 10,000 identified as having it," he said. "That is why screening is so important.

"It is important that the average person not be afraid or ashamed to be screened because there is better recognition of the problem, and we can address it before we get to a point where the situation is irretrievable," Dr. Rustgi said.

Walid F. Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said the hepatitis debate "may be a harbinger of whatís to come" with expensive drugs to treat various illnesses.

"A lot of drugs are really expensive, but they are not used for conditions as common as hepatitis C," he said. "These decisions about what drugs to cover and what to screen for are extremely difficult decisions."

For now, many of those decisions are made by Medicare and private health insurance providers. Treating people early to prevent huge costs in 20 years might seem like a no-brainer in terms of cost and conscience.

"But not everyone who has hepatitis C will end up with a transplant or cirrhosis, and we donít know how to exactly predict who those people will be," Dr. Gellad said. "I donít want to minimize it. This is an important cause of death and liver transplants, and a very important disease, but not everyone who gets the infection ends up with these advanced conditions."

One issue being debated is the cost to research, develop, test and manufacture the drugs. That question arose in recent weeks when the pharmaceutical company Gilead announced agreements to sell generic sofosbuvir overseas at the dramatically reduced price.

Gilead is seeking FDA approval for yet another revolutionary hepatitis C medication ó a fixed-dose pill that combines sofosbuvir with the experimental drug ledipasvir that has been shown to cure hepatitis C in just eight weeks in most cases. "Everyone will be waiting with bated breath to see how it will be priced," Dr. Gellad said.

The pharmaceutical company said a regimen of Solvadi (sofosbuvir) "is the most cost-effective treatment option for patients" infected with the primary type of hepatitis C because of fewer treatment failures and adverse events, along with averted liver-disease costs. Earlier use of Solvadi, it says, "yields better health and economic outcomes compared with later initiation," by reducing such complications as cancer and the "downstream costs associated with advancing (liver) disease."

In the JAMA report, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America said such drug prices "drive up health insurance premiums and put a strain on state Medicaid budgets."

"Unless the prices of the new drugs decrease, public and private insurers face an untenable spike in short-term costs and will be forced to develop stringent patient eligibility criteria as the only way to manage the tension between access and affordability," said Daniel A. Ollendorf of the Institute for Clinical and Economic Review in Boston, who studied the cost-effectiveness of using the new drugs.



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