Efavirenz, also known as EFV or Sustiva, is a type of medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI). NNRTIs block reverse transcriptase, a protein that HIV needs to make more copies of itself. Efavirenz was approved by the FDA on September 17, 1998, for use with other antiretroviral agents in the treatment of HIV infection in adults and children ages 3 and older. This medicine does not cure HIV infection or AIDS and does not reduce the risk of passing the virus to other people. Efavirenz may also be used with other antiretroviral medications to prevent HIV in people who have been exposed to the virus in the work place, such as health care providers who come in contact with HIV infected blood through an accidental needle stick.
Shionogi-ViiV Healthcare LLC today announced that initial results have been received from the Phase III SINGLE (ING114467) study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1.
A Johns Hopkins expert in the drug treatment of HIV disease and AIDS is spearheading an international effort to radically shift the manufacturing and prescribing of combination therapies widely credited in the last decade for keeping the disease in check for 8 million of the 34 million infected people worldwide.
A new once-daily pill combining three antiretrovirals and a booster molecule is a safe and effective alternative to two widely used drug regimens for newly diagnosed HIV-positive adults who have had no previous treatment. The findings of two large international randomised trials published in this week’s Lancet also indicate that the new “Quad” pill is faster acting, doesn’t have the neuropsychiatric side effects associated with other combinations, and could improve compliance with treatment.
Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.
Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.
Using a mathematical formula that carefully measures the degree to which HIV infection of immune system cells is stalled by antiretroviral therapy, AIDS experts at Johns Hopkins have calculated precisely how well dozens of such anti-HIV drugs work, alone or in any of 857 likely combinations, in suppressing the virus. Results of the team's latest research reveal how some combinations work better than others at impeding viral replication, and keeping the disease in check.
HIV-positive mothers have been able to guard against transmitting the disease to their babies by taking antiretroviral drugs during pregnancy. Although the drugs prevent children from being born with HIV, they could cause birth defects, such as cleft lip and palate. A new study explores any links between antiretroviral prophylaxis and cleft lip and palate.
Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Viread in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.
Gilead Sciences, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults.
Merck, known as MSD outside the United States and Canada, today announced results of new exploratory pre-specified analyses from the ongoing STARTMRK Phase III study of its integrase inhibitor ISENTRESS (raltegravir) Tablets in combination therapy compared to efavirenz in combination therapy in previously untreated adult HIV-1-infected patients.
Gilead Sciences, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera.
Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300 mg/300 mg, co-packaged with Nevirapine Tablets, 200 mg.
Gilead Sciences, Inc. today announced that the second pivotal Phase 3 clinical trial of its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada.
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Complera, a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.
Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor EDURANT tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults.
Merck, known as MSD outside the United States and Canada, today announced final results from a Phase II clinical study, extending out to 240 weeks, of its integrase inhibitor ISENTRESS® (raltegravir) Tablets in combination therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients.
The current issue of the Lancet is dedicated to HIV/AIDS, a theme meant to coincide with the sixth International AIDS Society (IAS) conference on HIV pathogenesis, treatment and prevention taking place in Rome, Italy, July 17-20, according to a Lancet article.
A small group of committed AIDS activists and advocates spearheaded by AIDS Healthcare Foundation (AHF) will protest the Bay Area's own Gilead Sciences over its pricing and policies on its HIV/AIDS medications.
Tobira Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies for HIV, announced today that it has initiated a Phase IIb clinical trial for the CCR5/CCR2 inhibitor cenicriviroc (TBR-652).
The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).
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