U.S. ratification of anti-AIDS “triple play” drug
U.S. Food and Drug Administration (FDA) 7 Yue 12 announced approval of Atripla Tablets - A widely used by the three kinds of anti-retroviral drugs consisting of fixed-dose group party drugs, once a day, each one , alone or with other anti-retroviral drugs used in conjunction with treatment of adults with AIDS virus (HIV) -1 infection.FDA believes that this drug has changed the past, HIV (AIDS) patients have to take a day or two to two kinds of drugs, medication way to enable patients to more easily adhere to treatment, being able to follow the course of treatment and how to treat equally important.
The drug is the first once a day, each one for the treatment of HIV / AIDS drugs, which includes the Su-stiva (generic name: efavirenz efavirenz), Emtriva (generic name: emtricitabine emtricitabine), Viread (generic name: tenofovirdisoproxilfumarate tenofovir disoproxil fumarate) is the active ingredient.
FDA in 1998 approved Sustiva, in 2001, approved Viread, in 2003, approved Emtriva.In addition, this group of three kinds of drugs for safety and effectiveness of herbs in a period of 48 weeks of clinical trials to be proved.244 patients with HIV-1 infected adults who received Atripla, the results of 80% of the subjects a significant reduction in HIV, health, a substantial increase in the number of CD4 cells (CD4 cells are the fight against HIV infected cells).
Atripla was approved by FDA in May 2004 was outlined in a guide for the “speed up the review process” result.”Atripla simplifies the approval by the HIV-1 infected adults, treatment programs, and will be the ability to improve patient adherence to treatment and thus long-term effective control of HIV-1, this has affected many of the most popular countries in AIDS patients with a a particularly important benefit. “FDA Acting Director Andrew C.vonEsche-nbach said.
“This new product is to provide prescriptions for a popular choice, they follow with at least three kinds of highly active antiretroviral there began HIV-1 drug treatment proposal, and this program may be a significant improvement in many patients the condition, and to help them adhere to treatment programs, so that the least resistance to the virus generated. “FDA’s CDER, Dr. Steven Galson, director, said,” because the three kinds of components Atripla have been used for some time, so their identity and role is very clear . ”
Atripla includes a boxed warning label: use of the drug may cause lactic acidosis (accumulation of lactic acid in the blood).In patients with chronic hepatitis B patients, the cessation of Atripla therapy (Atripla is not approved for this use) may lead to a serious attack of hepatitis B infection.Other reports using the Altripla ingredients may cause serious adverse events include: severe liver toxicity, renal impairment and severe depression.The combination trial, the subjects experienced the most common adverse events include: headache, dizziness, abdominal pain, nausea, vomiting and rash.
United States currently has more than 100 million people HIV-infected people and AIDS patients, and reported each year 40,000 cases of new cases.At present, the United States, 28 products have been approved for the treatment of HIV infection.
It is reported that the drug will be approved after the seven days on sale.
