Hepatitis B and C

Hepatitis B and C

Hepatitis C: Did You Know?

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The CDC issued a recommendation that all Americans born from 1945-1965 get tested for hepatitis C. People in this age group are five times more likely to have hepatitis C, but most do not know they are infected. If you were born from 1945-1965, talk to your doctor about getting tested.

The word “hepatitis” means inflammation of the liver. Hepatitis is most often caused by one of several viruses, which is why it is often called viral hepatitis. In the United States, the most common types of viral hepatitis areHepatitis A, Hepatitis B, and Hepatitis C.

Millions of Americans have viral hepatitis and an estimated 72,000 become infected each year. When a person first gets viral hepatitis, he or she can develop a very mild illness with few or no symptoms or get a more serious illness lasting months. Hepatitis B and Hepatitis C can progress to a “chronic” or lifelong infection, which can cause serious health problems including liver damage, cirrhosis, liver cancer, and even death. Most people with chronic hepatitis do not know they are infected and can live with the disease for decades without having symptoms, or feeling sick.

Hepatitis B is a liver disease caused by the Hepatitis B virus (HBV). It ranges in severity from a mild illness, lasting a few weeks (acute), to a serious long-term (chronic) illness that can lead to liver disease or liver cancer.  You can get Hepatitis B when you have contact with infectious blood, semen, and other body fluids from having sex with an infected person, sharing contaminated needles to inject drugs, or from an infected mother to her newborn.

Hepatitis C is a liver disease caused by the Hepatitis C virus (HCV). HCV infection sometimes results in an acute illness, but most often becomes a chronic condition that can lead to cirrhosis of the liver and liver cancer. You can get Hepatitis C when you have contact with the blood of an infected person, primarily through sharing contaminated needles to inject drugs.

To learn more about the National Viral Hepatitis Action Plan and what HHS is doing about viral hepatitis, visit:www.AIDS.gov/hepatitis

2015 Updates

• 07/24/2015 Approval of Daklinza in Combination with Sofosbuvir for HCV Genotype 3 Infection
• 07/24/2015 Approval of Technivie to treat of genotype 4 chronic hepatitis C virus
• 04/15/2015 FDA approved changes to the Olysio (simeprevir) package insert
• 03/24/2015 FDA Drug Safety Communication: Harvoni and Sovaldi
• 03/21/2015  Important safety information: Harvoni , and Sovaldi

2014 - 2012 Archived Updates

• 12/19/2014 VIEKIRA Pak (ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets) approval
• 11/24/2014 FDA launches new clinical trials demographic data page - seeking comments
• 11/05/2014 Changes to Olysio (simeprevir) label
• 10/10/2014 Approval of Harvoni fixed-dose combination tablet (ledipasvir and sofosbuvir) for treatment of Hepatitis C
• 03/20/2014 Baraclude (entecavir) labeling changes expand pediatric indication
• 02/12/2014 Changes to Victrelis (boceprevir) label add new safety information
• 01/22/2014 Victrelis (boceprevir) label changes update contraindications and drug interactions

2013

• 12/20/2013 Changes to the Baraclude (entecavir) package and label
• 12/19/2013 New PegIntron Selectdose single-use, dual-chamber pre-filled pen injector
• 12/06/2013 Approval of Sovaldi (sofosbuvir) tablets for the treatment of chronic hepatitis C
• 11/25/2013 Olysio (simeprevir) for the treatment of chronic hepatitis C in combination antiviral treatment
• 10/29/2013 Changes to Incivek (telaprevir) product labeling
• 10/28/2013 Draft - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment
• 09/25/2013 Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab)
• 07/26/2013 Changes to VIREAD (tenofovir DF) labeling for Hepatitis B
• 06/20/2013 Approval of genotyping test for patients with hepatitis C virus
• 04/25/2013 Changes to label for Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
• 03/01/2013 Vicrtelis (boceprevir) label changes
• 02/14/2013 Victrelis (boceprevir) label updates
• 01/29/2013 Tyzeka (telbivudine) label revisions

2012

• 12/21/2012 Important safety information and labeling changes for Incivek (telaprevir)
• 11/30/2012 Hepsera (adefovir dipivoxil) package insert updated to add new safety information
• 11/02/2012 Victrelis (boceprevir) labeling update
• 08/27/2012 Viread labeling updates
• 06/26/2012 Incivek (telaprevir) product labeling revised
• 04/20/2012 Victrelis (boceprevir) label change reflects drug-drug interaction information with HIV protease inhibitors
• 03/01/2012 Important information about interactions between certains hepatitiC drugs and cholesterol-lowering statin drugs
• 02/09/2012 Victrelis (boceprevir) and Ritonavir-Boosted HIV Protease Inhibitor Drugs - Drug Interactions

2011 - 2009 Archived Updates

• 12/23/2011 Important updates to PegIntron labeling
• 12/20/2011 Intron A (Interferon alfa-2b) product labeling changes
• 11/29/2011 CLIA waiver expands availability of rapid blood test for antibodies to the hepatitis C Virus (HCV)
• 11/09/2011 Safe disposal of needles and other medical sharps
• 09/29/2011 Pegasys (peginterferon alfa-2a) new disposable autoinjector
• 08/23/2011 Pegasys and Copegus - pediatric indication for patients 5-17 years of age
• 08/10/2011 Labeling change for Pegasys and Copegus re: dosing patients with renal impairment
• 06/06/2011 Labeling change for Intron A (Interferon alfa-2b) and PegIntron (Peginterferon alfa-2b)
• 05/25/2011 FDA briefing on boceprevir and telaprevir
• 05/23/2011 Approval of Incivek (telaprevir), a direct acting antiviral drug (DAA) to treat hepatitis C (HCV)
• 05/13/2011 Approval of VICTRELI (boceprevir) a direct acting antiviral drug (DAA) to treat hepatitis C virus (HCV)
• 04/26/2011 FDA Antiviral Advisory Committee April 28, 2011 meeting background materials available: telaprevir for Hepatitis C
• 04/25/2011 FDA Antiviral Advisory Committee April 27, 2011 meeting background materials available: boceprevir for Hepatitis C
• 04/07/2011 April 28, 2011 advisory committee meeting re: hep B testing in source plasma donations
• 04/01/2011 Labeling changes to Tyzeka (telbivudine) 600 mg tablets and oral solution 100 mg/5 mL reflect risk of resistance-associated substitutions
• 03/15/2011 FDA Advisory Committee meeting to consider boceprevir and telaprevir, April 27 and April 28, 2011
• 02/08/2011 Important information about alcohol prep pads packaged with Pegasys and certain other injection products
• 12/23/2011 Tyzeka (telbivudine) labeling updates re: use with pegylated interferon alfa-2a

2010 Archived Updates

• 12/16/2010 New Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination
• 10/22/2010 New Baraclude (entecavir) tablets and oral solution dosing regimen for chronic Hepatitis B and decompensated liver disease
• 09/14/2010 Availability of draft Guidance: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment
• 07/06/2010 Infergen (interferon alfacon-1) label revision: combination therapy, weight-based dosing, and label format
• 06/28/2010 Rapid blood test for antibodies to the hepatitis C virus (HCV) approved
• 03/10/2010 Public Hearing and Request for Comments: Expanded Access to Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C Infection in Patients With Unmet Medical Need

2009 Archived Updates

• 08/01/2012 Victrelis (boceprevir) label updated to reflect additional drug-drug interactions
• 09/01/2009 New class safety labeling updates for alpha interferon products
• 08/12/2009 New Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs
• Dose adjustments of PegIntron and Rebetol for certain patients with chronic hepatitis C
• Important information about Hydroxycut dietary supplement products
• Approval of new oral solution of Tyzeka for treatment of chronic hepatitis B (HBV)