FDA reviews two promising new drugs for hepatitis C

by Matthew Perrone

Doctors may soon have two new drug options to treat patients with hepatitis C, just as the liver-destroying virus becomes a major public health issue for millions of Americans reaching retirement age.

The Food and Drug Administration holds a public meeting this week to review two experimental medications from two U.S. firms, Johnson & Johnson and Gilead Sciences. The new drugs, if approved, could offer a quicker, more effective approach to eliminating hepatitis C, a blood-borne disease blamed for 15,000 deaths in the U.S. this year.

In a review posted online Tuesday, the FDA said J&J's simeprevir posted slightly higher cure rates than currently available treatments, though it also caused rashes and sunburn in some patients.

On Thursday the FDA will ask a panel of outside experts whether the drug should carry warnings about rashes and sunburn on its label. The agency is not required to follow the panel's advice, though it often does.

The meeting comes at a time when federal health officials are urging baby boomers to get tested for the virus, which can go unnoticed for decades before causing symptoms.

Between 3 million and 4 million Americans are infected with the hepatitis C virus, and people born between 1945 and 1965, known as baby boomers, are five times more likely to have the virus than people of other age groups.

Many contracted the virus by sharing needles or having sex with an infected person in their youth. The disease was also spread by blood transfusions before 1992, when blood banks began testing for the virus.

"If something is not done soon, all these people who were infected in the 60s and 70s are going to start experiencing the long-term consequences of liver disease," said Gaston Picchio, head of hepatitis drug development for J&J's Janssen Therapeutics unit.

Most people with hepatitis C do not even know they have the virus until liver damage has occurred, causing abdominal pain, fatigue, itching and dark urine.

For most of the last 20 years, the standard treatment for hepatitis C involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Many patients failed to complete the full treatment cycle, or delayed starting treatment at all in the hopes that more effective treatments would come along.

Two drugs approved in 2011 kicked off a new effort to treat the disease. Research shows that adding the two new drugs—Vertex Pharmaceuticals' Incivek and Merck & Co.'s Victrelis—to the older two-drug therapy can boost cure rates to between 65 and 75 percent.

And the drugs FDA is reviewing this week have the potential to push cure rates even higher.

J&J's simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA. Additionally, the vast majority of patients were able to cut their treatment time in half to 24 weeks, compared with the usual 52 weeks. The New Brunswick, New Jersey, company is seeking approval to combine the daily pill with the standard treatment regimen for patients with the most common form of the virus. J&J developed the drug with Swedish drugmaker Medivir.

On Friday, the same FDA panel will review another hepatitis C drug from Gilead Sciences Inc. that some analysts think will become the first-choice for treating the disease. The pill, known as sofosbuvir, has shown cure rates up to 90 percent after just 12 weeks in some company studies. Additionally, analysts believe the drug will eventually be used without interferon, the injectable medication used in the standard drug cocktail that causes nausea, diarrhea and other unpleasant side effects.

Gilead is racing against other drugmakers to develop the first all-pill therapy for hepatitis C, long viewed as the holy grail of treatment options by drugmakers. Similar efforts are underway from Abbott Laboratories and Bristol-Myers Squibb Co., among others.

Pharmaceutical industry consulting firm Decision Resources estimates the market for C drugs will grow to more than $23 billion by 2018. Sales of the drugs are expected to decline to $17.5 billion by 2021 as more are cured of the virus, according to a report.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Abbott Labs rises on hepatitis C drug data (Update)

Oct 15, 2012

Abbott Laboratories said Monday that its experimental hepatitis C drug regimen cured 99 percent of patients in a midstage study with the most common and hardest-to-treat type of the disease.

US regulators approve new hepatitis C drug

May 14, 2011

US regulators on Friday approved the first new treatment for hepatitis C in more than a decade, a Merck pharmaceutical known as Victrelis, to be taken with the current two-drug regimen.

More drugs show promise in fighting hepatitis C

Aug 15, 2013

(HealthDay)—An experimental drug duo may cure some cases of the liver disease hepatitis C, without the severe side effects of standard therapy, a new clinical trial suggests.

New hepatitis C drug shows potential in phase 2 trials

Oct 10, 2013

The addition of danoprevir to the current treatment regimen for patients with hepatitis C leads to high rates of remission, according to a new article in Gastroenterology, the official journal of the American Gastroenterological Associ ...

FDA panel endorses Vertex hepatitis C drug

Apr 28, 2011

(AP) -- Federal health experts say an experimental hepatitis C drug from Vertex Pharmaceuticals Inc. is a significant step forward in treating the virus, despite a high rate of rashes among patients taking the tablet.

Recommended for you

A new tool in drug overdose prevention

21 hours ago

The Center for Disease Control reported earlier this month that the heroin overdose death rate across 28 states it surveyed doubled between 2010 and 2012. This sharp increase and the chilling statistics that say more than 11 ...

Nasal spray treats heroin overdose

Oct 28, 2014

"Every year, drug overdoses are responsible for roughly 1000 ambulance calls in Oslo," says Arne Skulberg, an anaesthesiologist, a PhD candidate at NTNU and the 2014 winner of Norway's Researcher Grand Prix ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.