The FDA has approved several new cures for hepatitis C, but the drugs are so costly, some insurers will only cover them for the sickest patients.
Hepatitis C treatment is getting faster, simpler, and more effective. Patients on the new hepatitis C medication, Harvoni, need only pop one pill per day. Some can be cured in as little as eight weeks. And patients who take Viekira Pak, a new combination pill, for 12 to 24 weeks, don't need an added injection. This is a huge difference from just a few years ago, when hepatitis C patients had to take ribavirin pills and interferon injections for almost a year, and most weren't cured.
“Harvoni is very easy to take, it doesn't have any significant side effects,” says David Bernstein, MD, chief of hepatology for the North Shore LIJ Health System in Manhasset, N.Y. “The only thing that you see is some patients get an occasional mild headache, which is easily treatable with aspirin or Tylenol.”
Prior interferon-containing combo treatments had side effects that included anemia, depression, and flu-like symptoms among others.
Here's the problem: The newer hepatitis C drugs are super-expensive. Harvoni rings in at $1,125 per pill, or $94,500 for a 12-week course of treatment, and other new medications are nearly as pricey. Insurers are scrambling to figure out how to pay for treatment without breaking the bank. Many say they will only cover costly therapies for the sickest patients. In comparison, the cost 11 out of 12 cancer drugs the FDA approved in 2012 for cancer chemotherapy was over $100,000 for a one-year treatment course.
“Really curing hepatitis C is now within reach for a majority of the patients that we see,” says Andrew Aronsohn, MD, an assistant professor of medicine at The University of Chicago Medicine and an expert on hepatitis treatment. “The big issue revolves around cost and access to care.”
Several other new hepatitis C treatments are awaiting FDA approval. “The hope is that with lots of competition and more drugs out there, the price will go down,” says Dr. Aronsohn. “That's certainly what we're hoping for.” A potential problem with using the new drugs is how to know which will be best for an individual patient, when compared to other new treatments.
Hepatitis C TreatmentsHere's a rundown of US Food and Drug Administration-approved treatments for hepatitis C, from newest to oldest.
Viekira Pak: Approved December 2014. Viekira Pak is an interferon-free, all oral cure for hepatitis C for patients who have genotype 1 infections, including those with cirrhosis. The combination is ombitasvir, paritaprevir, and ritonavir pills, combined with dasabuvir pills. It is sometimes used with ribavirin. Patients take the drug for 12 to 24 weeks, and it cures over 95 percent.
Harvoni: Approved October 2014. Harvoni is a combination of sofosbuvir (Sovaldi) and ledipasvir. The drug cured more than 90 percent of patients with hepatitis C type 1, the most common form in the United States, after 12 weeks of treatment. Some patients who have not taken antiviral drugs before can be cured in eight weeks. “It's quite a transformative medication,” Dr. Bernstein says.
Sovaldi: Approved December 2013. Sovaldi is also a once-a-day pill, taken in combination with ribavirin or interferon. A course of treatment lasts 12 weeks, versus 24 to 48 weeks for older treatments. Some doctors have been prescribing an off-label combination (meaning not specifically FDA-approved) of Sovaldi with Olysio (simeprevir) to avoid side effects associated with the older drugs. The two-drug combo costs roughly $150,000 for a course of treatment. Patients with hepatitis C genotype 2 and genotype 3 are currently treated with a combo of Sovaldi and ribavirin, while patients with genotype 4 — who are very rare in the United States — must still be treated with interferon and ribavirin.
Olysio (simeprevir): Approved November 2013. Olysio is a once-a-day pill and, like Sovaldi, approved for use in combination with interferon and ribavirin. It is approved for treating hepatitis C genotype 1. The drug combination cured 80 percent of those with hepatitis C in 24 weeks, including patients who failed earlier drug treatments.
Telaprevir (Incivek/)/Boceprevir (Victrelis): Approved May 2011. Telaprevir and boceprevir were the first new treatments available for hepatitis C in 20 years. These drugs were also the first to directly attack the hepatitis C virus. Both are protease inhibitors, and prevent the virus from making copies of itself. Either must be taken along with ribavirin and interferon, but the course of treatment for the triple combo takes 24 weeks, versus 48 weeks for the interferon/ribavirin only regimen. Cure rates are about 80 percent with the telaprevir-based combo, while the boceprevir-based combo cures about two-thirds of patients.
Issues in curing hepatitis C today are cost and access to care.
Ribavirin: Approved in 1998. Patients take this oral medication twice a daily, and it must be used in combination with interferon. Side effects include a serious form of anemia that can make heart disease worse and lead to a heart attack. A course of interferon/ribavirin therapy lasts 48 weeks, and will cure about 40 percent to 45 percent of patients.
Interferon: Approved in 1991. Interferon is a human-made copy of an infection-fighting substance produced by immune-system cells. Patients must take it by once-weekly injection. Side effects can be severe, and include depression, irritability, flu-like symptoms, and blood abnormalities. When the drug was used on its own to treat hepatitis C, patients had to take it for 12 to 18 months. This lengthy treatment cleared the virus in just 20 percent of patients.