April 19, 2013

New Options for Treating HCV/HIV Coinfection on the Horizon

Paul E. Sax, MD

Apr 19, 2013

Hi. This is Dr. Paul Sax from Brigham and Women's Hospital and Harvard Medical School. Infectious disease and HIV specialists, hepatologists, and other clinicians who take care of patients with hepatitis C received some very exciting news recently: New drug applications for simeprevir and sofosbuvir, 2 investigational hepatitis C drugs, were submitted to the FDA.

The submissions were for at least genotype 1 hepatitis C, for use in combination with interferon and ribavirin. Notably, the sofosbuvir treatment course looks like it's going to be shorter, at 12-16 weeks. In addition, sofosbuvir is seeking approval for genotypes 1 and 3 in the submission in combination with ribavirin -- an interferon-free option.

This is very exciting. Both of these drugs are given once daily and look to have a much better toxicity profile than our existing hepatitis C protease inhibitors. But there are additional reasons why this information is very exciting, in particular for HIV care providers.

First, as you know, approximately 15%-20% of the HIV population in the United States is coinfected, and in some regions it's much higher. Second, treatment with our current standard of care, which is interferon-ribavirin plus telaprevir or boceprevir, has been challenging because of toxicity and drug-drug interaction issues. So there was a lot of room for improvement.

Third, we saw some very exciting data at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) combining these 2 drugs, simeprevir and sofosbuvir.[1] Granted, that was in hepatitis C monoinfected patients, but the combination looked like it had outstanding results even without the use of interferon.

There is an emerging consensus in the field that using regimens that have direct activity against hepatitis C will make the HIV coinfection component of the population much less relevant in the future. A lot of other things, too, may be less relevant, such as IL-28B status, race, and prior treatment failure. All of these are harbingers for good things and progress in the hepatitis C treatment front.

I think we need to stay tuned for new data in this exciting area with the European liver meetings coming up later this month. Also, keep in mind for your patients who have HIV/hepatitis C coinfection that, if they're stable and if they don't have evidence of advanced liver disease, one could very easily make the argument that waiting for newer drugs such as simeprevir and sofosbuvir to be approved makes a lot of sense.

Thanks very much. There is more information on this topic on my blog, HIV and ID Observations. I hope you have a very nice spring, and I hope it's warmer than it is here in Boston, where it is still freezing.

  1. Lawitz E, Ghalib R, Rodriguez-Torres M, et al. Suppression of viral load through 4 weeks post-treatment results of a once-daily regimen of simeprevir + sofosbuvir with or without ribavirin in hepatitis c virus GT 1 null responders. Program and abstracts of the 20th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, Georgia. Abstract 155LB.

Medscape HIV/AIDS © 2013 WebMD, LLC


Even moderate drinking may be risky with hepatitis C

By Kerry Grens

NEW YORK | Fri Mar 15, 2013 4:19pm EDT

NEW YORK (Reuters Health) - For people with the chronic liver infection hepatitis C, heavy drinking is an obvious no-no, but a new study links even modest alcohol consumption with an increased risk of death - and not just from liver disease.

"What this study shows is... truly, even what might be considered a moderate and safe amount of alcohol use in people without hepatitis C is dangerous to your health if you have hepatitis C," said Rae Jean Proeschold-Bell, a hepatitis C researcher at Duke University in Durham, North Carolina, who was not involved in the study.

The findings support what liver specialists typically recommend - that people with hepatitis C should limit their alcohol use, said Dr. Zobair Younossi, the study's lead author and chair of medicine at Inova Fairfax Hospital in Falls Church, VA.

"Patients with hepatitis C should not really drink," he said.

But the reality is that people with hepatitis C have higher rates of alcohol use than people without the liver disease, said Proeschold-Bell, who studies interventions to reduce drinking among people with the disease.

Doctors have known that excessive drinking can exacerbate liver disease caused by hepatitis C, but there's some debate about whether less frequent drinking would have a similar effect.

Younossi and his colleagues looked to a large national survey on health and lifestyle that tracked people for several years.

They compared 8,767 people without hepatitis C to 218 people with the disease.

Hepatitis C is a virus spread through blood. Some 3.2 million people in the U.S. have a chronic hepatitis C infection, according to the Centers for Disease Control and Prevention.

The disease can cause serious liver damage, and while some people are treated with medications, others will go on to require a liver transplant.

The survey tracked the participants for 13 to 14 years. During that period, 19 percent of those with hepatitis C and 11 percent of those without the infection died.

Younossi's team found that people with hepatitis C who drank excessively - three or more drinks a day - were five times more likely to die than heavy drinkers who were not infected.

That result was not surprising, "We've known heavy drinking is particularly bad if you have hepatitis C," Proeschold-Bell told Reuters Health.

But people infected with hepatitis C who had up to two drinks a day were also twice as likely to die during the study than those with similar drinking habits who were not infected.

For the purposes of the study, a drink was equivalent to 10 grams of alcohol, which is roughly the amount in four ounces of wine, 12 ounces of beer or one ounce of hard liquor.

Younossi said the increased risk of death from liver disease is driving the numbers.

"What is incredibly striking is liver-related death in patients with hepatitis C who even drink moderately," said Younossi.

For instance, the risk of liver-related death among people with hepatitis C who averaged two or fewer drinks a day was 74 times that of similar people without hepatitis C.

Those moderate drinkers with the virus were also nearly three times more likely to die of "all causes," the researchers report in the medical journal Alimentary Pharmacology & Therapeutics.

"A drink a day is not OK," Younossi told Reuters Health. "Even a moderate amount of alcohol use in the setting of hepatitis C can increase the risk of death and liver-related mortality specifically."

Proeschold-Bell said there is a great opportunity for intervening with people's alcohol use given that they are already interacting with the medical system if they have a chronic hepatitis C infection.

"This is potentially very powerful, because if the person with hepatitis C is already going in for medical care, they have some relationship with that clinic. They have some degree of trust, so (perhaps) you can provide alcohol treatment right then and there," she said.

Younossi said there's some evidence that if heavy drinkers without hepatitis C abstain from alcohol, their liver disease can improve.

He said he suspects the same might be true for patients with the infection, but that future studies will have to confirm that hunch.

SOURCE: bit.ly/W2Rtwn Alimentary Pharmacology & Therapeutics, online February 24, 2013.