Orlando doctors help find hepatitis C cure

The FDA may have just approved a breakthrough cure for hepatitis C.

Harvoni, a drug from Gilead Sciences, was approved on Oct. 10 after three studies doing eight, 12 or 24-week treatments on nearly 2,000 patients with hepatitis C liver disease. In more than 90 percent of trial patients, hepatitis C was undetectable in their blood 12 weeks after treatment, which doctors consider a cure.

And an Orlando doctor helped make it happen. Dr. Avanish Aggarwal, a board certified doctor in internal medicine and gastroenterology, was one of the few investigators in the clinical trials across the country, which he performed at his practice Central Florida Gastroenterology in Orlando.

“We’re actually talking cure, which is phenomenal, I mean when I went through [medical training], to talk about a cure would be impossible,” Aggarwal said.

Hepatitis C, which affects 3.2 million Americans, is a contagious liver disease primarily spread by contact with infected blood. Many don’t know they have the disease because it can present no noticeable symptoms, but chronic hepatitis C can lead to serious liver problems, including cirrhosis (scarring of the liver) or liver cancer. It causes more deaths annually than HIV/AIDS, is the leading cause of liver cancer and transplants, and is responsible for $30 billion in current annual health costs, costs that are expected to nearly triple by 2030.

The drug enables patients to discontinue use of older drugs, including Interferon, which causes debilitating side effects, such as constant flu-like symptoms and depression.

Many with hepatitis C choose to forego treatment because they were more afraid of the side effects of Interferon than the sometimes little-to-no symptoms they experience from hepatitis C, said Dr. Federico Hinestrosa, an infectious diseases specialist at Orlando Immunology Center who treats patients with hepatitis C.

“The main problem we saw [with the old drugs] was that there was a significant amount of side effects, Interferon makes you feel like you’ve got a bad case of the flu, so patients would get really sick and many patients wouldn’t be able to tolerate it at all so we’d have to stop it, and it would be for a whole year, 48 weeks, so this is a long time to be feeling sick,” Aggarwal said. “Even with a full year of therapy, with three drugs, we were still only getting about half to two-thirds of the patients were responding.”

The main criticism of the medication is its cost. A Harvoni pill costs $1,125 and a 12-week treatment is $94,500. Many insurance companies and Medicare programs won’t pay that, so strict guidelines are likely to be imposed allowing only the sickest access to Harvoni. Hinestrosa said if a patient has excellent insurance that approves the drug it would cost them approximately $50-100 per month.

But Hinestrosa did say that Harvoni is no more expensive than treatments used even 10 years ago, because patients had to be treated more than once and there were significant complications from treatment requiring hospital stays and medical procedures.

Aggarwal said patients on Harvoni suffer side effects that are at most a headache or fatigue, and none of the five in his trial chose to quit from side effects. The trial was for one year in 2013, and no patients had relapsed after being tested again after six months.

“It’s just very gratifying to be able to use something that can make a profound difference in the health of my patients, especially in a condition that up until now we’ve had very little to offer,” Aggarwal said. “It’s totally thrilling when you’re talking to a patient, a young couple when you talk to them and see the joy in their faces when you tell them that their hepatitis is gone and you don’t have to worry.”