April 2, 2014

Hepatitis C Drug Trials to Take Spotlight at Liver Congress

Miriam E. Tucker
April 02, 2014

New all-oral interferon-free treatment regimens for hepatitis C will take center stage at the European Association for the Study of the Liver (EASL) International Liver Congress 2014, with an unprecedented number of phase 3 trials demonstrating cure rates of up to 100%.

The congress will take place April 9 to 13 in London, United Kingdom.

"There are a lot of very important things being discussed, but I think what really stands out are the remarkable results achieved in several trials on the treatment of hepatitis C, particularly genotype 1, which is the most difficult to treat," explained Giorgina Mieli-Vergani, MD, who is honorary president of the EASL.

"Hepatitis C is a major killer in the world, and doctors have been trying for a long time to find the best way of treating it. Now we are very close to being able to treat it very effectively — this is a major, major thing coming out of this congress," Dr. Mieli-Vergani told Medscape Medical News.

In fact, "we've never had this many phase 3 studies in one conference before, said Markus Peck-Radosavljevic, MD, secretary-general of the EASL. "They will be changing clinical practice."

Dr. Markus Peck-Radosavljevic

The studies will show that "without interferon, by combining 2 or 3 drugs, you can cure hepatitis C in 95% and 99% of cases, which means essentially you can cure everybody with very little side effect," said Dr. Peck-Radosavljevic told Medscape Medical News.

Moving "Very, Very Fast"

Some of the most highly anticipated phase 3 results are from the SAPPHIRE trials, which evaluated 12-week regimens of ribavirin plus ABT-450/r, ABT-267, and ABT-333, under development by AbbVie, in patients with genotype 1 hepatitis C. SAPPHIRE I involves treatment-naïve patients and SAPPHIRE II involves treatment-experienced patients.

Also anticipated are results from the ION-2 study, which evaluated the fixed-dose combination of sofosbuvir plus ledipasvir (Gilead Sciences), with and without ribavirin, in treatment-naïve and treatment-experienced patients with genotype 1 hepatitis C.

Dr. Giorgina Mieli-Vergani

The once-daily sofosbuvir/ledipasvir pill appears to work in a short period of time in the most difficult-to-treat patients, and with far fewer adverse effects than regimens containing pegylated interferon. Dr. Mieli-Vergani called the results "amazing."

"I am a pediatrician, and this is exceedingly exciting for me," she told Medscape Medical News. "The current oral drug regimens require up to 12 pills a day, which is impossible for a child. There are no trials in children yet, but they will follow." Although hepatitis C is much less common in children than in adults, 6% to 7% of infected mothers pass along the infection to their infants, she explained.

New treatment guidelines for hepatitis C from the World Health Organization — primarily addressing the developing world — will be presented at the meeting.

Also presented will be EASL guidelines on hepatitis C. Although they were published online in December 2013, they are already outdated, Dr. Peck-Radosavljevic told Medscape Medical News (J Hepatol. 2014;60:392-420).

"Things are moving very, very fast. We will definitely need to update again within a year," he said. The organization will probably stop printing the guidelines on paper and only house them online so that they can be continually updated, he said.

Hallway Conversation

Not officially on the agenda but sure to be discussed is the high cost of new drugs for hepatitis C. "How all people who need it are going to be able to have it, I don't know," said Dr. Mieli-Vergani.

Dr. Peck-Radosavljevic pointed out that "companies have to recover their cost of development and satisfy their investors." But, he added, "you have a drug curing a deadly disease in 100% of patients. If you put that into perspective, the pricing is not outrageous."

Both he and Dr. Mieli-Vergani predict that the prices will eventually drop, as was the case with the HIV drugs.

Beyond Hepatitis C

Beyond hepatitis C, new information on numerous liver disease-related topics, including hepatitis B and D, nonalcoholic fatty liver disease, hepatocellular carcinogenesis, liver regeneration, and noninvasive assessment of liver disease, will be featured, and beginner and advanced sonography workshops will be offered.

Of note, phase 3 data will be presented on the use of obeticholic acid (Intercept Pharmaceuticals) for the treatment of primary biliary cirrhosis.

"This is a new type of drug. It's very interesting because it's the first time in many years we will have a new drug that works in primary biliary cirrhosis," said Dr. Peck-Radosavljevic.

The current treatment, ursodeoxycholic acid, has been on the market for about 40 years. "It helps, but doesn't work for all patients, so it is really quite important to have something new here," he said.

Primary biliary cirrhosis is an autoimmune liver disease of major interest to Dr. Mieli-Vergani. She is looking forward to meeting with 40 to 50 fellow members of an international ad hoc autoimmune hepatitis interest group that meets every year at the EASL and major liver meetings, she told Medscape Medical News.

"Autoimmune liver disease is a small part of the meeting, but a very intense and important part," she said.

Another "small but important" topic is children with liver disease. They are by and large surviving into adulthood now and transitioning to adult hepatology care, Dr. Mieli-Vergani explained.

"When I started doing pediatric hepatology 40 years ago, 60% of my patients died within 2 years of diagnosis. There were many conditions we didn't understand or know how to treat. Transplantation didn't exist. Nowadays, it's about 5%," she reported.

It is challenging for adult hepatologists, she said, because these patients are very different from those who develop liver disease in adulthood. In the United Kingdom, efforts have been made to ease the transition by having pediatric, adolescent, and adult specialists coordinate care for the patient during a transition period.

"Pediatrics is a very small part of the meeting, but the fact that they have me as the honorary president is a very nice sign," she told Medscape Medical News.

Dr. Mieli-Vergani reports receiving research funding from Roche, and being a consultant for Roche, Bristol Myers Squibb, and Novartis. Dr. Peck-Radosavljevic reports consulting for or receiving speaker honoraria from BMS, AbbVie, Gilead, Merck, Roche, Lilly, Bayer, Boehringer, and GlaxoSmithKline.

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