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2014 Viral Hepatitis Year-in-Review and Looking to 2015

Ronald Valdiserri

2014 has been a year of both opportunities and challenges in the fight against viral hepatitis. In May, the World Health Assembly passed a new resolution  [PDF 151 KB] on viral hepatitis, urging member states to develop and implement coordinated, national strategies for preventing, diagnosing and treating viral hepatitis.  Our nation’s own comprehensive viral hepatitis strategy,…

FDA Commissioner Margaret A. Hamburg’s statement on FDA’s blood donor deferral policy for men who have sex with men

FDA

The U.S. Food and Drug Administration is a science-based regulatory agency that works to protect and promote the public health. In this role, it is our responsibility to regulate the blood supply and to help ensure its continued safety for the patients who receive these life-saving products. Over the past several years, in collaboration with…

FDA approves Viekira Pak to treat hepatitis C

FDA

The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Hepatitis C is a viral disease that causes inflammation of the liver that…

For an AIDS-Free Generation: Access to Drugs and Diagnostics Is Essential

FDA

On World AIDS Day this year, tens of millions of people with HIV are now living healthy, productive lives because of access to safe and lower priced medicines. We rejoice in this achievement, because all people, no matter how rich or poor, deserve to have the medicines they need to live their lives in the…

FDA approves first combination pill to treat hepatitis C

FDA

The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs…

Faster, Easier Cures for Hepatitis C

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Transformative advances in drug treatments approved by the Food and Drug Administration are giving the 3.2 million Americans with chronic hepatitis C a chance for a longer, healthier life without the virus. That’s welcome news for baby boomers—who make up three of four adults with the hepatitis C virus—and millions of other Americans, many of…

FDA approves Sovaldi for chronic hepatitis C

FDA

Drug is third with breakthrough therapy designation to receive FDA approval The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. “Today’s…

FDA Safety Communication: Reducing the Risk of Hepatitis B Reactivation in Patients Using Two Immune-Suppressing and Anti-Cancer Drugs

FDA

On September 25, 2013, the Food and Drug Administration (FDA) issued a Drug Safety Communication announcing that the FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The…