Lopinavir News and Research

RSS

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

Switching from protease inhibitors to Nevirapine brings superior results for some HIV-infected children

Nevirapine is widely used to help prevent mother-to-child transmission of the HIV virus. In cases where the infants are nonetheless infected with HIV virus at birth, the standard treatment is to use protease inhibitors (PI) to reduce the amount of virus in their bloodstream. A new study involving 195 infants in South Africa found that children who were treated with PI and then switched to nevirapine were more likely to maintain virus below the detection threshold of the test than infants who continued to receive PI.

9 Sep 2010

Switching to nevirapine drug from PI based regimen reduces viremia in children: Study

HIV infected children in South Africa who were exposed to the drug nevirapine at birth (used to help prevent mother to child HIV transmission) and then received a protease inhibitor (PI) for viral suppression achieved lower rates of viremia (virus in the blood stream) if they were switched to nevirapine, compared to children who continued on the PI-based regimen, according to a study in the September 8 issue of JAMA.

8 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.

20 Jul 2010

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

Research on new types of anti-HIV drugs presented at International Microbicides Conference

Researchers testing a vaginal microbicide based on a new type of anti-HIV drug found it provided monkeys significant protection against infection with a virus similar to HIV, according to a study reported at the International Microbicides Conference in Pittsburgh today.

24 May 2010

PROVENGE receives FDA approval for treatment of CRPC

Dendreon Corporation today announced that the U.S. Food and Drug Administration has approved PROVENGE (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer.

30 Apr 2010

EndoChoice granted FDA marketing clearance for BONASTENT Esophageal and Biliary Stent platforms

EndoChoice, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its BONASTENT® Fully Covered Esophageal Stent for the treatment of malignant esophageal obstructions, and its BONASTENT Uncovered Biliary Stent for the treatment of malignant biliary obstructions.

30 Apr 2010

Gilead Sciences doses first patient in Quad Phase III clinical program

Gilead Sciences, Inc. today announced that it has dosed the first patient in the Phase III clinical program evaluating its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat (formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate.

13 Apr 2010

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010

Phase 3b ODIN study of once-daily PREZISTA in HIV-1 adults presented at CROI 2010

In a new study of treatment-experienced HIV-1-infected adults with no PREZISTA® (darunavir) resistance-associated mutations (RAMs), 72 percent of patients in the PREZISTA/ritonavir (r) (800/100 mg) once-daily arm achieved undetectable viral loads (<50 copies/mL) compared with 71 percent of patients in the PREZISTA/r (600/100 mg) twice-daily arm. The study met its primary objective of non-inferiority. These data from the Phase 3b ODIN study were presented today at CROI 2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco.

18 Feb 2010

FDA grants approval for Abbott's antiretroviral medication Norvir

Abbott announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir ® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients.

11 Feb 2010

Labeling update for Tibotec Therapeutics' PREZISTA tablets approved

Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for PREZISTA® (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN studies.

29 Jan 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

Eli Lilly and Kowa Pharmaceuticals America to co-promote LIVALO in the U.S

Eli Lilly and Company (NYSE: LLY), Kowa Company, Limited, and Kowa's U.S. subsidiary, Kowa Pharmaceuticals America, Inc., today announced that Lilly and Kowa Pharmaceuticals America have entered into a co-promotion agreement in the United States to commercialize LIVALO® (pitavastatin). Lilly and Kowa have also entered into a licensing agreement in Latin America. LIVALO is a statin approved by the U.S. Food and Drug Administration (FDA) in August 2009 for the treatment of primary hyperlipidemia and mixed dyslipidemia.

24 Dec 2009

AstraZeneca's CRESTOR receives favorable vote from FDA Advisory Committee

The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) today voted 12 yes, 4 no, and 1 abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of CRESTOR®

16 Dec 2009

Tibotec Therapeutics' INTELENCE granted FDA traditional approval

The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents.

25 Nov 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

Pros and cons of HIV treatments in developing countries

Palumbo is co-leading a clinical study of anti-HIV medicines in Africa and India for the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). The randomized trial found that a cohort of 82 HIV-infected children ages 6 to 35 months responded better to treatment with the protease-inhibiting drug lopinavir (LPV/r) than did a cohort of 82 children in the same age group who received the anti-retroviral drug nevirapine (NVP).

16 Sep 2009