Vertex Pharmaceuticals Inc. said Friday it will work with Bristol-Myers Squibb Co. to study a potential hepatitis C treatment regimen that includes Bristol-Myers Squibb's drug daclatasvir and Vertex's VX-135.
Both drugs are taken orally. Vertex said it will start a clinical trial of the once-per-day regimen during the second quarter. The study will involve patients with untreated genotype 1 hepatitis C, which is the most common type of the hepatitis C virus and the hardest to treat. If the results of that trial are good, Vertex will begin a second trial later in the year including patients with genotypes 1, 2, and 3, including some patients with cirrhosis of the liver.
Hepatitis C is a virus that can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. The disease is spread through the blood, and that can happen through sharing intravenous drug needles or having sex with an infected person. Most people who are infected with the virus carry it as a long-term, chronic condition.
Vertex, of Cambridge, Mass., makes the hepatitis C pill Incivek. Incivek was seen as a major new treatment when it was approved in 2011, but sales have fallen sharply because the drug has been linked to a dangerous skin rash and because doctors may be advising patients to wait until future treatments become available before beginning treatment.
Incivek is taken with the pill ribavirin and the drug interferon, which must be injected and can cause nausea, diarrhea, and other unpleasant side effects. Several companies are studying treatment regimens that don't involve any intravenous drugs.
Hepatitis C has become a major area of research for drug companies in recent years, partly because diagnoses are expected to increase due to the large, aging population of U.S. baby boomers. While the virus can cause dangerous liver damage, infections can also be asymptomatic or cause more general symptoms. Around 4 million Americans are believed to have the disease, but many are undiagnosed.
Bristol-Myers is conducting late-stage testing of daclatasvir. The drug is also being studied in combination with sofosbuvir, a promising drug developed by Gilead Sciences Inc. VX-135 is in mid-stage testing.