New Hepatitis Drug Approved

A new drug may aid in the treatment of hepatitis c.

The Food and Drug Administration (FDA) has issued their approval of a new medicine for hepatitis C that, when combined with other drugs, can make for a fast treatment of the disease that damages the liver.

“Sofosbuvir” is the name of the new medication and it is manufactured by Gilead Sciences, Incorporated. One specialist in treatment of the liver called it a revolution in treating diseases that attack the organ.

A spokesman for Johns Hopkins Hospital in Baltimore says that over the next year and a half, the FDA will be approving a series of pharmaceuticals that will simplify  hepatitis C treatments and increase the rate of recovery to above 90 percent.

The hepatitis C virus affects more than three million Americans and is the country’s number one cause of cancer of the liver. It is also the top reason for liver transplants. Most of those with the disease show no symptoms until their livers begin to fail. Liver failure produces fatigue, jaundice, and other issues.  Up until recently, the recommended three drug treatment regimen has taken up to a maximum of 48 weeks and required patients to inject themselves with interferon. Interferon is an immune therapy drugs that often causes severe flu symptoms as well as mood swings.

Sofosbuvir is expected to be the first treatment regimen that some hepatitis patients will be able to take for just three months and only have to take one other drug. No interferon will be necessary. The FDA approved this medication for particular patients who are diagnosed with two variations of the virus. The variations are known as genotypes 2 and 3. Most patients who have the more common type, known as genotype 1, can have sofosbuvir but must be taken with interferon and another older medicine called ribavirin. Some of those patients will still have to undergo treatment for six months.

No medication regimen is expected to be 100% effective. However, one case study shows that nearly 90 percent of patients suffering from genotype 1 who took the three drug version were cured in approximately three months.  This is in comparison with a 75 percent cure rate in available regimens that last longer.

There are no clear side effects to sofosbuvir nor does it appear to conflict with any of the medications that are paired with it. Patients taking sofosbuvir with ribavirin may encounter insomnia and fatigue and ones who take interferon will have other side effects. However, both will have it for a shorter period of time than past experienced.

A one month supply of sofosbuvir, being sold under the brand name “Solvadi” will be $28,000, according to a press release from Gilead.

Medical experts say that with this medication introduced, therapies are expect to continue evolving. As an example, some physicians may look to recent studies and treat some genotype 1 patients with a mixture of an antiviral medicine (called simeprevir) and sofosbuvir. Under this treatment, no interferon will be administered. This would be experimental in nature since, although the FDA has approved simeprevir, it has not approved combining it with sofosbuvir. Although such use is not illegal, it is not clear whether or not it will be insured.

In January, two medical associations are expected to publish online treatment guidelines to aid doctors in making decisions in the ever changing field.

Hepatitis C is one of many viruses that is known to cause liver damage. Vaccines are available for the prevention of hepatitis A and B. However, there is no vaccination for hepatitis C. Sixteen thousand people a year are infected with the virus and close to 80 percent are chronic.

The virus spreads rapidly through the bloodstream and is often contracted through the sharing of drug needles and inadvertent needle sticks. Some even contract it through birth. Transmission through unsanitary tattooing and sex is also possible.

The approval of the new drug is expected to be one of many steps in the reduction of the severity of hepatitis C.

By Rick Hope

USA Today

New York Times