The first combination pill to treat chronic hepatitis C virus genotype 1 infection was approved by the Food and Drug Administration Oct. 10.
The once-daily tablet under the trade name Harvoni combines 400 mg of the already-approved hepatitis C drug sofosbuvir (Sovaldi) with 90 mg of a new drug, ledipasvir, and is the first approved regimen that does not require coadministration of interferon or ribaviron to treat hepatitis C in adults, according to the FDA.
Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
In three clinical trials with a total of 1,518 patients, 94%-99% reached a sustained virologic response (no virus detected in the blood) at least 12 weeks (SVR 12) after finishing treatment, according to an FDA statement. The agency gave the drug fast-track consideration and approval under its breakthrough therapy designation.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” Dr. Edward Cox, director of the FDA Office of Antimicrobial Products said in a statement. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens,.”
The FDA approved sofosbuvir and another new drug to treat hepatitis C, simeprevir (Olysio), in late 2013. Since then, the high costs of these new treatments have generated controversy. Even before Harvoni’s approval, one analysis estimated that the new treatments could increase 2015 spending in Medicare’s Part D program by up to $5.8 billion.
Gilead, which markets sofosbuvir and the new combination pill, said in a statement that a typical 12-week course of Harvoni will cost $94,500, compared with Sovaldi’s price tag of $84,000 for 12 weeks, the New York Times reported. Some patients may be successfully treated after 8 weeks.
In the first of Harvoni’s three pivotal trials, cure rates were 94% after 8 weeks of treatment and 96% after 12 weeks of treatment in previously untreated patients with chronic hepatitis C infection. In the second trial including patients with and without cirrhosis, 99% were cured after 12 weeks of treatment. In the third trial of treatment-experience patients with or without cirrhosis, 94% were cured after 12 weeks of treatment and 99% after 24 weeks of treatment. Adding ribavirin did not improve response rates in any of the trials.
The FDA recommended a dosage duration of 12 weeks in patients with chronic hepatitis who have not previously been treated or who failed treatment but don’t have cirrhosis, or 24 weeks in patients with cirrhosis who failed previous treatment. Limiting treatment to 8 weeks may be considered in treatment-naive patients without cirrhosis who have pretreatment hepatitis C virus RNA levels below 6 million IU/mL.
The most common adverse reactions reported with Harvoni use included fatigue in 13%-18%, headache in 11%-17%, nausea in 6%-9%, diarrhea in 3%-7%, and insomnia in 3%-6%.
Both drugs in Harvoni interfere with enzymes needed by hepatitis C virus to multiply. Ledipasvir is a hepatitis C virus NS5A inhibitor, and sofosbuvir is a hepatitis C virus nucleotide analog NS5B polymerase inhibitor.
On Twitter @sherryboschert