After 12 weeks, virus was undetectable in up to 99 percent of participants
8:55 AM - June 30, 2016
FDA on Tuesday approved Gilead Sciences' Epclusa, the first combination therapy to treat all six forms of hepatitis C. FDA approved the drug under the agency's priority review program.
Most Americans with hepatitis C have the genotype 1 form of the disease. About 20 to 25 percent have genotypes 2 or 3, and small percentages have genotypes 4, 5, or 6. Other genotypes are more common elsewhere in the world.
Epclusa details
Epclusa is a pill that combines Gilead's Sovaldi with velpatasvir, a new anti-viral drug.
Three phase III clinical trials of Epclusa that involved 1,558 participants found that after 12 weeks of treatment, the hepatitis C virus was undetectable in 95 to 99 percent of participants without cirrhosis of the liver or with mild liver cirrhosis. The virus also was undetectable among 94 percent of 87 participants with moderate or severe liver cirrhosis who were treating with Epclusa in conjunction with ribavirin.
Gilead strikes deal to make costly hepatitis C drug affordable in poorest nations
FDA approved the drug for individuals with hepatitis C who do or do not have liver cirrhosis. The agency said individuals with moderate to severe cirrhosis should use Epclusa in combination with ribavirin.
Epclusa costs $74,760 per 12-week treatment course, according to Gilead. That price does not include discounts the drugmaker will offer.
"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C" Edward Cox, director of FDA's Office of Antimicrobial Products, said in a statement (Berkrot/Kuber, Reuters, 6/28; AP/Los Angeles Times, 6/28; Rothenberg, MedPage Today, 6/28).
How 5 organizations integrated pharmacists into their primary care teams
Drug-related morbidity and mortality cost nearly $200 billion annually in the United States, leaving many providers wondering, "How can we more effectively deploy our pharmacists to help reduce avoidable spending?"
Download this briefing to learn how five organizations integrated pharmacists into their primary care teams to improve patient outcomes and reduce costs.
8:55 AM - June 30, 2016
FDA on Tuesday approved Gilead Sciences' Epclusa, the first combination therapy to treat all six forms of hepatitis C. FDA approved the drug under the agency's priority review program.
Most Americans with hepatitis C have the genotype 1 form of the disease. About 20 to 25 percent have genotypes 2 or 3, and small percentages have genotypes 4, 5, or 6. Other genotypes are more common elsewhere in the world.
Epclusa details
Epclusa is a pill that combines Gilead's Sovaldi with velpatasvir, a new anti-viral drug.
Three phase III clinical trials of Epclusa that involved 1,558 participants found that after 12 weeks of treatment, the hepatitis C virus was undetectable in 95 to 99 percent of participants without cirrhosis of the liver or with mild liver cirrhosis. The virus also was undetectable among 94 percent of 87 participants with moderate or severe liver cirrhosis who were treating with Epclusa in conjunction with ribavirin.
Gilead strikes deal to make costly hepatitis C drug affordable in poorest nations
FDA approved the drug for individuals with hepatitis C who do or do not have liver cirrhosis. The agency said individuals with moderate to severe cirrhosis should use Epclusa in combination with ribavirin.
Epclusa costs $74,760 per 12-week treatment course, according to Gilead. That price does not include discounts the drugmaker will offer.
"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C" Edward Cox, director of FDA's Office of Antimicrobial Products, said in a statement (Berkrot/Kuber, Reuters, 6/28; AP/Los Angeles Times, 6/28; Rothenberg, MedPage Today, 6/28).
How 5 organizations integrated pharmacists into their primary care teams
Drug-related morbidity and mortality cost nearly $200 billion annually in the United States, leaving many providers wondering, "How can we more effectively deploy our pharmacists to help reduce avoidable spending?"
Download this briefing to learn how five organizations integrated pharmacists into their primary care teams to improve patient outcomes and reduce costs.
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