TRENTON, N.J. (AP) — An experimental drug for one of the hardest-to-treat types of hepatitis C has been approved by the Food and Drug Administration, adding to the surge of new options — all much more effective but extremely costly — for patients with the liver-destroying virus.
Daklinza, developed by New York-based Bristol-Myers Squibb Co., is the first drug approved to treat genotype 3, the second-most-common form. About 10 percent of Americans with hepatitis C have genotype 3.
Because genotype 3 is so hard to cure and damages the liver more quickly than other types, Daklinza is to be taken with Sovaldi, one of two blockbuster hepatitis C drugs sold by market leader Gilead Sciences Inc., along with Harvoni.
Meanwhile, the FDA on Friday also approved Technivie, a combination drug made by AbbVie Inc. for one of the least common forms of hepatitis C, genotype 4. Technivie also must be taken with a second drug, a much-older, generic pill called ribavirin.
Daklinza will be available within a week, and Technivie in late August, according to their makers.
The spate of new pills launched since Sovaldi hit the market in 2013 has dramatically changed treatment for hepatitis C, a virus that silently damages the liver over many years.
Roughly 2.7 million Americans have it and millions more in other countries are infected. Most have no idea until the damage is done: decreased liver function, cirrhosis, liver failure requiring a transplant, liver cancer, infections, bleeding, jaundice and excess fluid in the abdomen.
For decades, treatment required pills and periodic injections that caused awful flu-like side effects, lasted for up to a year and only cured about 60 percent of patients. A few years ago, more-effective and shorter treatments were launched, including Victrelis from Merck & Co. and Olysio from Johnson & Johnson. Their sales plunged dramatically after Sovaldi was launched in December 2013, followed by Harvoni in October 2014 and AbbVie Inc.'s Viekira Pak in December 2014.
Those three drugs have slashed treatment time to 12 weeks and boosted cure rates to more than 90 percent, depending on which of several strains, or genotypes, the patient has and how advanced the person's disease is.
For example, in patients who didn't have cirrhosis, one daily pill each of Daklinza and Sovaldi produced an apparent cure — meaning the virus remained undetectable in the blood six months after treatment ended — in 98 percent of new patients tested and 92 percent previously given another treatment. Among patients who had liver-scarring cirrhosis, about two-thirds were cured.
The testing included a total of 152 patients. Primary side effects were fatigue and headache.
However, the pills come with eye-popping price tags.
Bristol-Myers said the list price for Daklinza, also known as daclatascir, will be $63,000 for a 12-week course of treatment.
Similarly, list price for a 12-week course of treatment is about $84,000 for Sovaldi, $95,000 for Harvoni and $83,300 for AbbVie's Viekira Pak. Technivie will be priced at $76,653, AbbVie said.
While insurers have been extracting discounts estimated at up to 40 percent for Sovaldi, Harvoni and Viekira Pak as a condition of covering them, the drugs have become poster children for the steep escalation in prices for new prescription medicines.
The trend is raising alarm about the ability to afford new drugs among insurers, government health programs, doctors and patients, who often must pay a significant percentage of the cost. Some insurers reportedly are limiting the number of new patients starting on the three drugs.
Their makers counter that they offer payment assistance to poorer patients and that the pills save money over the cost of liver transplants, hospitalizations and other care under the older treatment regimens.
It's unclear how the two new treatments will affect the battle for market supremacy. Gilead had a slight head start and is by far the leader. It posted first-quarter sales of $3.6 billion for Harvoni, a combination drug that includes Sovaldi's active ingredient, and sales of $972 million for Sovaldi. It reports its second-quarter results on Tuesday.
AbbVie just reported second-quarter sales of Viekira Pak totaling $385 million, barely qualifying it as a blockbuster, a drug with annual worldwide sales exceeding $1 billion.
AbbVie's drugs have the disadvantage of requiring patients to take two or three daily pills, plus ribavirin pills twice a day. Patients on Harvoni need only one pill a day. Those taking Daklinza must also take Sovaldi. And those prescribed Sovaldi need to take ribavirin once a day and, in some cases, periodic injections of an immune system protein called interferon.
Follow Linda A. Johnson at www.twitter.com/LindaJ_onPharma