FDA Alerts
Combo HIV Tablet Approved
The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
FDA Approves New Rx for Combination with Other HIV Medications
On September 24, 2014, FDA approved Vitekta (elvitegravir) 85 mg and 150 mg tablets.
FDA Approves New Rx for Combination with HIV Medications
On September 24, 2014, FDA approved Tybost (cobicistat) 150 mg tablets. Tybost is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection.
FDA Approves New Drug to Treat HIV Infection
The US Food and Drug Administration today approved Tivicay ( dolutegravir ), a new drug to treat HIV-1 infection.
Rapid Diagnostic Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies
The US 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.
FDA Approves First Anti-Diarrheal Drug for HIV/AIDS Patients
The US Food and Drug Administration today approved Fulyzaq ( crofelemer ) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.
Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies. Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite.
Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes ...
FDA Discovers Autoimmune Mechanism for Drug Reactions
A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.
Victrelis and HIV Drug Interactions
The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis ( boceprevir ), a hepatitis C virus ( HCV ) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time.
Because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz ( atazanavir ), ritonavir-boosted Prezista ( darunavir ), and Kal...
Hepatitis C and HIV Drug Interactions
The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and patients that drug interactions between the hepatitis C virus ( HCV ) protease inhibitor Victrelis ( boceprevir ) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors ( atazanavir , lopinavir , darunavir ) can potentially reduce the effectiveness of these medicines when they are used together.
FDA Approves New HIV Drug
On March 25, 2011, FDA approved VIRAMUNE XR ( nevirapine ), a 400 mg extended release tablet formulation.
VIRAMUNE XR is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.