A new federal guideline recommending all baby boomers be tested for the potentially fatal hepatitis C virus could expand the market for treatments made by Vertex Pharmaceuticals Inc. and other drug makers by up to 80 percent, according to projections.
But doctors’ slow acceptance of the recommendation from the Centers for Disease Control and Prevention could delay any major influx of new customers for several years, long enough to allow a new generation of drugs to reap most of the benefit, analysts cautioned.
“The market will expand significantly,” said biotechnology analyst Howard Liang, managing director at health care investment bank Leerink Swann in Boston. “But these [hepatitis C tests] may not be in wide practice until new drugs are on the market.”
Industry watchers estimate as many as 4 million Americans carry the virus, which can eventually lead to scarring of the liver or liver cancer, but about 75 percent do not know they have it. One-time blood tests for those born between 1945 and 1965 have the potential to add 800,000 diagnosed cases to about 1 million already diagnosed, the CDC estimated.
If the newly identified patients get treatment, it could prevent more than 120,000 deaths of people who might otherwise develop liver diseases, said Bryce Smith, lead health scientist for the CDC’s Division of Viral Hepatitis in Atlanta. Based on past recommended screenings, however, Smith acknowledged it is hard to predict implementation.
“It’s going to be adopted at different rates in different settings,” Smith said. “Some health care systems will adopt these recommendations very quickly, other systems will be slower in adopting it. But there’s a real push to try to ramp this up significantly.”
A CDC study concluded the baby boom generation was most at risk of having the virus because of the possibility of exposure decades ago from drug use, tattooing, or blood transfusions in an era when the blood supply was not screened for the virus. The study was funded by Cambridge-based Vertex along with rival Merck & Co., the Genentech division of Roche AG, and Johnson & Johnson’s Janssen Pharmaceutical Cos.
“We support any effort that brings broader attention to this epidemic,” said Vertex spokeswoman Dawn Kalmar. “Hepatitis C is sometimes called the silent killer because so many people don’t know they have it. These new guidelines heighten the awareness.”
Kalmar would not discuss how the guidelines might boost sales of the company’s Incivek drug, approved by the Food and Drug Administration last year. It competes with a rival Merck treatment, approved about the same time. Both are protease inhibitors, which means they act to prevent replication of the virus. While taken orally, they are used in combination with other therapies, including injectable interferons, which might cause side effects.
Incivek initially beat market expectations because many doctors had “warehoused” hepatitis C patients — delaying treatment until the new standard of care had been approved, said Leerink Swann’s Liang. But a new class of oral drugs, now in clinical trials, can be taken in regimens that do not include interferon and thus are easier to tolerate, he said.
Those drugs — developed by Gilead Sciences Inc. and Abbott Laboratories, as well as Vertex — could start becoming available within two years, Liang said, just in time to capitalize on newly diagnosed hepatitis C cases stemming from CDC-recommended tests. A second round of warehousing may benefit those interferon-free drug regimens, he said.
“We’re going to see new types of all-oral regimens come to the market,” Liang said.