UPDATE: Sovaldi Approved - The Evolving Course of Hepatitis C Therapy
What is Chonic Hepatitis C Virus (HCV)?
What Are the Common Symptoms of HCV and How is it Diagnosed?
How Common is Hepatitis C Virus Infection and How Do You Get It?
Explain the Different Genotypes for Hepatitis C Virus
What's Involved With an HCV Diagnosis?
What Have Been the Standard HCV Treatments?
What Do Experts Suggest About Diagnosis and Treatment of HCV?
What's All the Buzz About New All-Oral HCV Treatments?
How Does Sovaldi (Sofosbuvir) Work in Hepatitis C Virus?
Sovaldi is known as a direct-acting agent (DAA), meaning that it interferes directly with the HCV life cycle by suppressing viral replication. Sovaldi is given as a once-a-day pill.
What Evidence Supports the Sovaldi FDA-Approval?
What is the U.S. Approval Status of Sofosbuvir?
How Does the Safety Data Look for Sovaldi?
How Does Olysio (simeprevir) Work in HCV?
What Evidence Supports the FDA-Approval of Olysio (simeprevir)?
What is the Approval Status of Olysio (simeprevir)?
What are Some Safety Concerns for Olysio (simeprevir)?
What's On the Horizon for Oral HCV Therapy?
Overview: HCV Late-Stage Drug and Class Pipeline
- NS3/4A protease inhibitors: Asunaprevir (BMS), ABT-450 (AbbVie), Faldaprevir (Boehringer Ingelheim) Danoprevir (Roche) Vedroprevir (Gilead)
- Non-nucleoside NS5B polymerase inhibitors: ABT-333 (AbbVie), BI-207127 (Boehringer Ingelheim) Tegobuvir (Gilead) ABT-072 (AbbVie)
- NS5A inhibitors: ABT-267 (AbbVie), Daclatasvir (BMS), Ledipasvir (Gilead) GSK2336805 GlaxoSmithKline
What About Costs of New HCV Treatments?
HCV Research: What Questions Still Remain?
Finished: UPDATE: Sovaldi Approved - The Evolving Course of Hepatitis C Therapy
- Tse MT. All-oral HCV therapies near approval. Nature Reviews Drug Discovery. 2013;12:409-11. Accessed November 17, 2013 at http://www.nature.com/nrd/journal/v12/n6/full/nrd4036.html
- Hepatitis Central.com. Hepatitis C. Are there different types of hepatitis C? Accessed November 12, 2013 at http://www.hepatitiscentral.com/hepatitis-c/hepatitis-c-genotypes.html
- You DM, Pockros PJ. Simeprevir for the treatment of chronic hepatitis C. Expert Opin Pharmacother. 2013;14:2581-89.
- Drugs.com. New Drug Combo Helps Hard-to-Treat Hepatitis C. Accessed November 18 at http://www.drugs.com/news/new-combo-helps-hard-hepatitis-c-47015.html
- Press release. Olysio (simeprevir) received FDA approval for combination treatment of chronic hepatitis C. Johnson and Johnson. November 22, 2013. Accessed November 22, 2013 at http://www.jnj.com/news/all/OLYSIO-simeprevir-Receives-FDA-Approval-for-Combination-Treatment-of-Chronic-Hepatitis-C
- Drugs.com. FDA Advisory Committee Supports Approval of Gilead's Sofosbuvir for Chronic Hepatitis C Infection. Accessed November 12 at http://www.drugs.com/nda/sofosbuvir_131025.html.
- Pollack A. Hepatitis C, a Silent Killer, Meets Its Match. The New York Times. Health, November 4, 2013. Accessed November 18, 2013 at http://www.nytimes.com/2013/11/05/health/hepatitis-c-a-silent-killer-meets-its-match.html?_r=0
- Hep. Your Guide to Hepatitis. Hepatitis C: The Basics. Accessed November 18, 2013 at http://www.hepmag.com/articles/2512_18753.shtml
- Drugs.com. Experimental Hepatitis C Drug May Treat the Untreatable. Accessed November 12, 2013 at http://www.drugs.com/news/experimental-hepatitis-c-may-untreatable-48706.html
- Press Release. Gilead Announces New Sustained Viral Response Data for Sofosbuvir-Based Regimens in Genotype 3-Infected Hepatitis C Patients. Gilead. Accessed November 14, 2013 at http://www.gilead.com/news/press-releases/2013/11/gilead-announces-new-sustained-viral-response-data-for-sofosbuvirbased-regimens-in-genotype-3infected-hepatitis-c-patients.
- FDA Antiviral Drug Advisory Committee Meeting. October 24, 2013. Backgrounder package for NDA 205123. Simeprevir (TMC435). Accessed November 20, 2013 at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371623.pdf.
- Press release. Gilead Announces Phase 3 Results for an All-Oral, Sofosbuvir-Based Regimen for the Treatment of Hepatitis C in Patients Co-Infected With HIV. November 2, 2013. Accessed November 19, 2013 at http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1871556&highlight=
- Hernandez R. Janssen’s Simeprevir: Hep C Patients Hope It Is Worth the Wait. July 8, 2013. Specialty Pharmacy Times. Accessed November 13, 2013 at http://www.specialtypharmacytimes.com/news/Janssens-Simeprevir-Hep-C-Patients-Hope-It-Is-Worth-the-Wait