A Big warning issued for hep C antivirals

Direct-acting antivirals can now cure every kind of hep C, quickly. The debilitating ordeal associated with the former treatment, interferon, is long gone. But for some patients, DAA treatment has a big-with a capital B—drawback.

The Federal Drug Administration has just ruled that a warning for people with hepatitis B must be included in packages of many direct-acting antivirals. The ruling came after the agency found 24 inactive cases of hepatitis B had become virulent among patients being treated for the C disease.

Unlike hep C, no cure exists for chronic hepatitis B. However, a vaccine can protect against it, and treatment can suppress replication of the virus.  But uncontrolled hepatitis B can cause liver failure.

The FDA warning on the hep C antivirals states that people infected with HBV risk reactivation of hepatitis B.

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New title for my book, would like to hear your ideas about this blog

My book about hepatitis C goes to the copy editor this week. In preparation, the publisher has firmed up the title. “The” will be removed from the beginning of the title. There’s a new subtitle too. Here’s the full title text:

Demon in My Blood: My Fight with Hep C–and a Miracle Cure

Getting the book to this point has been rewarding. As it moves toward publication in May I will continue posting to this blog about news concerning hepatitis C. If you’re interested in a particular topic, please let me know.  I’m always happy to hear from readers. –Elizabeth

 

Occasional alcohol after hepatitis C

Since my hepatitis C cleared after treatment with direct-acting antivirals, my liver went back to normal. My alcohol habits regressed somewhat too. I stopped drinking entirely when I was infected with hep, but now I’ve gone back to drinking a glass or two of wine on the weekend or when guests come by for dinner. Still, I remain wary about alcohol. I usually enjoy my beverage as a spritzer: half wine, half soda water.

circle and slash over beer mugs mean no drinkingFor those whose hep is yet to be cured even that much alcohol can accelerate the rate of liver damage. By how much? It’s impossible to predict. Yet some averages are known:

According to the U.S. Department of Veterans Affairs, the average man who is infected at age 40 or later and drinks a lot can expect a cirrhotic liver in thirteen years. The slowest progression occurs among non-drinking women under 40 who contract the disease early. It can take 40 years before their disease turns deadly.

But again, those are averages and everyone is different. The best bet for anyone who has hep is to drink no alcohol at all. For those who have been cured, be very cautious.

 

World Hepatitis Day can celebrate cures for all

On July 28, World Hepatitis Day will mark a milestone for those who have rare genotypes of heptatitis C. Epclusa, Gilead’s one-pill combination of sofosbuvir and velpatasvir, has been shown to cure genotypes 1 through 6.

Previously, those with genotypes 4 – 6 could be cured only with interferon. The drug often caused extreme flu-like symptoms as well as depression for close to a year. A large portion of patients abandoned treatment before they were cured.

Twelve weeks of Epclusa alone has proven 98 percent effective for those with almost all stages of liver damage. The drug taken with ribavirin has been shown to cure 94 percent of patients who have decompensated cirrhosis.

The cost of Epclusa is $75,000 for 12 weeks. That’s less than other direct-acting antiviral treatments, except for Merck’s Zepatier , priced at $54,000. Still, that’s about the same as the median annual household income  in the U.S. ($53,657 according to the 2014 Census). That’s a big price to pay, but at least now there’s hope for everyone.

Ultrasound recommend twice a year for some people who have cleared hep C

Two leading researchers have warned that many people who achieved sustained virologic response after anti-viral treatment should continue to be screened for liver cancer.

Roberta D’Ambrosio of the Migliavacca Center for Liver Disease in Italy and the Department of Pathology at Beaujon Hospital in France, and Massimo Colombo of the Migliavacca center, recommended the testing in this month’s Liver International journal. They advised hepatologists to continue the screening, particularly among patients who had decompensated chirrosis (the most advanced stage of liver disease) before their treatment.

SVR does not automatically reverse the ravages of hep. The researchers said some patients’ livers may have reached a point of no-return before they cleared hep C. Even when a patient’s liver seems to have regressed, not all measures of regression may be accurate, they suggested.

European guidelines recommend that anyone who achieves SVR after having decompensated cirrhosis get a liver ultrasound twice a year thereafter. Those who may have had less cirrhosis but abuse alcohol or suffer from diabetes or other risks should do so too, the guidelines state.

If your gastroenterologist isn’t doing this and you believe you’re at risk, maybe you should ask about getting an ultrasound.

 

 

Down Under is way up on top with hep C treatment

Australia recently became the first country in the world to make direct-acting antivirals free for all of its citizens who have hep C and are at any stage of fibrosis. The government health plan pays for the drugs.

Anyone who has hepatitis C and holds a Medicare Card (every Australian citizen gets one) can be treated though their general practitioner. The process is simple. After a person tests positive for HCV, their doctor consults with a hepatologist or gastroenterologist and writes the prescription. It doesn’t matter how high—or low—the person scores on a Fibroscan.

The country’s Prescription Benefit Scheme pays for the drugs. The patient pays either a $6 or a $38 dispensing fee, depending on income.

The unfettered, virtually free DAA treatment policy was introduced in March after intense campaigning from Hepatitis Australia and other advocacy groups.Map of Australia

Ribavirin still used for hep C–often to lower the treatment cost

Despite the demise of interferon, the debilitating drug that was used for two decades to treat hepatitis C, many patients must still deal with one component of the old treatment. Under the brand names CoPegus and Rebetol, ribavirin is sometimes prescribed in addition to direct-acting antivirals. Doctors most often prescribe it for difficult cases of hep C.

The difficult cases include patients with cirrhosis. Recent studies show that ribavirin combined with DAAs can reduce the length of treatment for many of these people (see Ribavirin: Past, present and future).

Ribavirin’s common side effects include anemia, insomnia and irritability. For some patients, the side-effects can be mild. Many doctors feel they are a small price to pay in exchange for big drug prices patients can’t afford. Twelve weeks of a DAA plus ribavirin instead of 24 weeks of a DAA alone could save a patient many tens of thousands of dollars. Ideally, patients and doctors shouldn’t have to think about that. But they do.