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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…

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…

FDA to Convene Meeting on HIV Patient-Focused Drug Development and HIV Cure Research

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The Food and Drug Administration (FDA) wants to talk to people living with HIV (PLWH) and HIV/AIDS advocates. On June 14, under its Patient-Focused Drug Development initiative, FDA will ask PLWH to join an open public discussion about: the impact of HIV on your daily life, experience with currently available therapies to treat HIV, your…

World AIDS Day

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Cross-posted from the FDA Blog World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically…