ADVERSE REACTION: see side effect
ADULTS: Older than 18 years old
CURE (SUSTAINED VIROLOGICAL RESPONSE (SVR)): HCV RNA is undetectable at week 12 post-treatment. Considered a viral cure.
DIRECT-ACTING ANTIVIRALS (DAAS): there are at least 4 categories of direct antivirals—protease inhibitors, polymerase inhibitors (nucleoside and non-nucleoside inhibitors) and NS5A inhibitors. DAA’s target and inhibit viral enzymes that are important for replication of the hepatitis C virus.
Drug Classes: “-previr” are NS3 protease inhibitors (example: grazoprevir); “-asvir” are NS5A inhibitors (example: obitasvir); “-buvir” NS5 polymerase inhibitors (example: (sofosbuvir).
DRUG INTERACTIONS: a reaction that occurs when drugs are taken together or drugs are taken with certain herbs or foods. Drug interactions may enhance or reduce the action of a drug and may increase its side effects, and could potentially cause life- threatening reactions.
FOOD AND DRUG ADMINISTRATION (FDA): the FDA is responsible for making sure the medicines (including veterinary drugs) are safe and effective. They are also responsible for the safety of the food supply, regulating tobacco products and cosmetics.
GENOTYPE: the genetic makeup of an organism. HCV has seven major genotypes (designated by the numbers 1 through 7). In the U.S., genotype 1a/b is most prevalent followed by genotype 3, 2, 4, 6, and 5. There have only been a few people identified with genotype 7 identified and there are no hepatitis C (HCV) medications are approved to treat it.
HEPATITIS C (HCV): the hepatitis C virus.
HIGHLIGHTS OF PRESCRIBING INFORMATION: information issued and approved by the FDA about a drug that lists pertinent information to treat a certain condition. It doesn’t have complete information about the drug. For all of the information included in the FDA approval refer to the Full Prescribing Information.
NS5A INHIBITOR: an agent that inhibits viral replication of the hepatitis C virus’ NS5a enzyme.
PEDIATRIC: Infants, children, and adolescents from birth up to the age of 18 years old.
POLYMERASE INHIBITOR: an agent that inhibits viral replication by interfering with the polymerase enzyme.
PROTEASE INHIBITOR: an agent that inhibits viral replication by interfering with the virus’ protease enzyme.
RAVs: see resistance-associated variants
RESISTANCE-ASSOCIATED VARIANTS (RAVs): hepatitis C mutations that form resistant strains that occur naturally, during treatment breakthrough or after treatment relapse. People with genotype 1a may need to be tested for RAVs to help with treatment medication choices.
SIDE EFFECT (ADVERSE REACTION): an undesired action or effect of a drug or other treatment.
SUBTYPE: a genetic variation of an organism. Subtypes are a more narrow classification than genotypes, but broader than quasi-species. Genotype 1 HCV is divided into subtypes 1a and 1b.
WHOLESALE ACQUISITION COST (WAC): is the price set by the pharmaceutical company, but doesn’t include discounts or rebates. It doesn’t reflect the actual cost of how much it takes to develop, produce and market the drug.