The HCV saga goes on: Epclusa has been approved for treatment of chronic Hepatitis C virus (HCV) infection
Last Updated on June 29, 2016 by Joseph Gut – thasso
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the genotype helps inform treatment recommendations and the duration of treatment. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small numbers of patients are infected with genotypes 4, 5 or 6. According to the Centers for Disease Control and Prevention (CDC), HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.
Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved as Sovaldi in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV. The safety and efficacy of Sofosbuvir/Velpatasvir (Epclusa) for 12 weeks was evaluated in three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95–99 percent of patients who received Sofosbuvir/Velpatasvir (Epclusa) had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured. The safety and efficacy of Sofosbuvir/Velpatasvir (Epclusa) was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis (moderate to severe cirrhosis), of whom 87 subjects received Sofosbuvir/Velpatasvir (Epclusa) in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.
The most common side effects of Sofosbuvir/Velpatasvir (Epclusa) include headache and fatigue. Sofosbuvir/Velpatasvir (Epclusa) and ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.
Sofosbuvir/Velpatasvir (Epclusa) carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Sofosbuvir/Velpatasvir (Epclusa) is not recommended. Sofosbuvir/Velpatasvir (Epclusa) also carries a warning not to use with certain drugs that may reduce the amount of Sofosbuvir/Velpatasvir (Epclusa) in the blood which could lead to reduced efficacy of Sofosbuvir/Velpatasvir (Epclusa).
Related posts
Enasidenib (Idhifa): Targeted treatment for relapsed or refractory AML
Brodalumab (Siliq) with a fatal touch: New psoriasis drug approved
BCR-ABL Tyrosine Kinase Inhibitors: Danger of HBV-Reactivation
Gene variants tied to increased risk of severe COVID-19 disease
The Clinical and Economic Impact of Inaccurate EGFR Mutation Tests in the Treatm...
Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
Can I just say what a relief to find someone who actually is aware of what theyre speaking about on the internet. You undoubtedly know find out how to carry an issue to mild and make it important. More individuals need to read this and perceive this side of the story. I cant consider youre no more common because you definitely have the gift.
Good article. I will be facing some of these issues as well..
The European Medicines Agency (EMA) has adopted, as of End of May 2016, a positive opinion on Epclusa as well:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004210/smops/Positive/human_smop_000990.jsp&mid=WC0b01ac058001d127
This means that Epclusa will be available in the European Union in a short amount of time also.