Efavirenz News and Research

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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.

MSD announces Phase 2b results of doravirine therapy in untreated patients with HIV-1 infection

Merck Sharp & Dohme Ltd. MSD (known as Merck & Co., Inc. in the United States and Canada), today announced the presentation of results from a Phase 2b clinical trial evaluating the safety and efficacy of once daily oral doravirine, an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), plus tenofovir/emtricitabine (TDF/FTC) compared to efavirenz plus TDF/FTC in previously untreated patients with HIV-1 infection.

4 Nov 2014

FDA approves ViiV Healthcare's Triumeq tablets for treatment of HIV-1 infection

ViiV Healthcare announced today that the US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.

23 Aug 2014

Merck enrolls first patient in reformulated raltegravir Phase 3 trial for treatment of HIV-1 infection

Merck, known as MSD outside the United States and Canada, today announced that the first patient has been enrolled in the company's global Phase 3 clinical trial, ONCEMRK.

6 Jun 2014

Dolutegravir drug offers added benefit in HIV patients

Dolutegravir has been approved since January 2014 in combination with other antiretroviral drugs for the treatment of human immunodeficiency virus (HIV) infected adults and adolescents above 12 years of age.

22 May 2014

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.

8 May 2014

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.

16 Mar 2014

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Today Boehringer Ingelheim announced results from STARTVerso4 in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups.

6 Mar 2014

New study explores the effect of food insecurity on treating HIV-infected pregnant women in Uganda

In Uganda the prescription of three antiretroviral (ARV) drugs, which aim to suppress the virus to prevent disease progression, have resulted in huge reductions in HIV mortality rates. However, disease is not the only scourge in Uganda, and a new study in The Journal of Clinical Pharmacology explores the impact food insecurity may have on treating pregnant women.

18 Feb 2014

Valproic acid metabolism and obesity: an interview with Dr. Namandjé Bumpus, Johns Hopkins Medicine

Valproic acid is one of the most widely prescribed drugs for the treatment of epilepsy. It has also been shown to be effective for the treatment of mood disorders and migraine headaches.

17 Feb 2014

Merck announces FDA approval of ISENTRESS for oral suspension

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration recently approved ISENTRESS for oral suspension, a new pediatric formulation of Merck's integrase inhibitor. With this approval, ISENTRESS is now indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older.

9 Jan 2014

Merck announces approval of NOXAFIL delayed-release tablets by FDA

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets.

27 Nov 2013

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

23 Nov 2013

FDA accepts Merck's NOXAFIL IV solution NDA for priority review

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous solution formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration.

18 Nov 2013

Gilead Sciences gets marketing authorization from European Commission for Vitekta tablets

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Vitekta (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir.

18 Nov 2013

Merck to present pharmacokinetic data on once-daily ISENTRESS at EACS

Merck, known as MSD outside the United States and Canada, is presenting pharmacokinetic data this week on investigational formulations of a once daily dose of ISENTRESS at the 14th European AIDS Conference, sponsored by the European AIDS Clinical Society.

17 Oct 2013

More AIDS-defining illnesses and severe side effects occur with appropriate comparator therapy

The drug combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil (elvitegravir fixed combination, trade name: Stribild) has been approved in Germany since May 2013 for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1).

21 Sep 2013

Scientists create polymer additives that enhance orally administered drugs to reach bloodstream

All too often, when a person takes a pill full of a potent and effective drug, the drug passes straight through the body, not reaching the organ where it is needed - a waste of money and inconvenient if it is a cold medicine, but potentially dire if it is a treatment for a serious illness.

29 Aug 2013

New polymer additives enhance ability of oral drugs to reach bloodstream

All too often, when a person takes a pill full of a potent and effective drug, the drug passes straight through the body, not reaching the organ where it is needed — a waste of money and inconvenient if it is a cold medicine, but potentially dire if it is a treatment for a serious illness.

28 Aug 2013

FDA: New drug Tivicay approved to treat HIV-1 infection

The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply.

13 Aug 2013

Research shows lower daily dose of HIV drug therapy suppresses virus

Millions more people could get access to life-saving HIV drug therapy, following a landmark study led by Australian researchers based at the Kirby Institute at the University of New South Wales (UNSW).

4 Jul 2013