Merck Challenges

Powerful new Merck compounds have taken the fight against Hepatitis C to a new level.

Combination therapy with grazoprevir/elbasvir in once-daily tablets showed high cure rates in research published today in the Annals of Internal Medicine for genotypes 1 (the most common) as well as genotypes 4 and 6.

When combined with Gilead’s Sovaldi (sofosbuvir) in another study (C-SWIFT), the treatment showed “spectacular results,” according to Dr. Douglas Dieterich of Icahn School of Medicine at Mount Sinai in New York City.

Dieterich, who lists that he is a consultant to both Merck and Gilead on his Mount Sinai professional profile, is attending the International Liver Congress in Vienna this week where the research was presented. He sat in on the presentation.

In a phase 3 clinical trial called C-EDGE, 412 patients infected with hepatitis C were given either the drug or a placebo. Of 316 patients who received the drug for 12 weeks, 95 percent had sustained viral response, often called an SVR or “cure,” for 12 consecutive weeks after treatment ended.

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Cure rates for genotypes 1a and 1b were 92 and 99 percent, respectively. All of those who had genotype 4 were cured, and 80 percent of those with genotype 6 had SVR after 12 weeks. One limitation of the study was the relatively few number of enrollees with genotypes 4 and 6, the authors noted.

The Merck-funded trial involved subjects from around the world, including the United States, Europe, Australia, Scandinavia, and Asia.

“Most HCV trials are now global,” Dieterich said. “They usually conduct the trials where they hope the drug will be approved.”

Baby Boomers, Drug Users at Risk for Hepatitis C

Hepatitis C is a bloodborne virus that attacks the liver, eventually causing cirrhosis, liver cancer, and even death. It is believed that 3.2 million people in the United States and as many 170 million people around the world are chronically infected.

In the U.S., three quarters of the infections are believed to be baby boomers (people born between 1946 and 1964), according to the U.S. Centers for Disease Control and Prevention (CDC). Because the disease can take decades to do noticeable damage, many people don’t know they have it until it has advanced to cirrhosis.

The CDC recommends every baby boomer in the nation get tested for hepatitis C. The disease was transmitted for many years via blood transfusions or in hospital settings before being identified in the late 1980s.

Some people may have contracted hepatitis C many years ago by injecting drugs and sharing needles or even snorting drugs and sharing a straw or dollar bill. Injection drug users continue to be at high risk for hepatitis C and are becoming infected in increasing numbers in the midst of a national heroin epidemic.

Many people with hepatitis C are incarcerated or dependent upon government health programs. The cost of antiretroviral drugs that cure the disease have been of concern both to those needing them and the systems that pay for them. Sovaldi carries an $84,000 price tag, the newer Harvoni $95,000.

Medications Can Even Cure the Very Sick

AbbVie’s entry into the hepatitis C market with Viekira Pak has provided access to the lifesaving drugs. Payers and pharmacy benefit managers have struck deals with individual pharmaceutical companies as new drugs come to market. In theory, an entry by Merck could have the same effect.

“AbbVie 3D has already forced prices down,” Dieterich told Healthline. “Merck will be a real competitor and will add price pressure as well.”

Some doctors, however, are dissatisfied with the model of payers teaming up with a pharmaceutical of choice. They want to be able to hand-pick which medication their patient gets.

Until Sovaldi came to market, people with hepatitis C often faced low cure rates with treatments such as interferon and ribavirin, both of which have debilitating side effects. Many people with hepatitis C eventually need a liver transplant.

People with hepatitis C often hear from insurance companies that they aren’t sick enough yet to qualify for the antiretroviral medicines, meaning their hepatitis has not advanced to the cirrhotic stage. Many people who do not get treatment and do advance to that stage later cannot be cured.

Dieterich said research presented at the liver conference this week also has included studies that show effectiveness in treating even the sickest patients with cirrhosis pre- and post-transplant.