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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

ucm405643

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…

FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies

FDA

The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1…

FDA approves first genotyping test for patients with hepatitis C virus

FDA

The U.S. Food and Drug Administration today approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient’s blood plasma or serum, will aid health…