Lamivudine News and Research

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Cipla, DNDi to develop ARV combination therapy for children with HIV/AIDS

On the eve of the XIX International AIDS Conference in Washington, DC, the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, announces a new collaboration with Indian drug manufacturer Cipla to develop and produce an improved first-line antiretroviral (ARV) combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV/AIDS.

21 Jul 2012

Gilead receives FDA approval for Truvada to reduce risk of sexually acquired HIV-1 infection

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

17 Jul 2012

Dolutegravir-based regimen demonstrates superiority over Atripla in treatment-naive adults with HIV-1

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.

12 Jul 2012

Combination regimens trump monotherapy in fight against HIV transmission

A two- or three-drug combination is more effective at reducing intrapartum HIV acquisition than zidovudine monotherapy in babies who are at high risk for transmission, a study in The New England Journal of Medicine shows.

25 Jun 2012

FDA ADAC recommends approval of Gilead’s Truvada for HIV

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.

11 May 2012

ViiV, Shionogi announce initial results from dolutegravir Phase III study on HIV-1

ViiV Healthcare and Shionogi & Co., Ltd. today announced that initial results have been received from the SPRING-2 (ING113086) Phase III study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1.

2 Apr 2012

Study explores links between antiretroviral prophylaxis, cleft lip and palate

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.

27 Jan 2012

WHO approves three Mylan ARV therapies to treat HIV/AIDS

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received approval for three antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization's (WHO) Prequalification of Medicines Programme. The products include:

20 Dec 2011

Merck announces results from ISENTRESS Phase III combination study on HIV-1

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.

14 Oct 2011

Bristol-Myers to present abstracts on research in liver disease at The Liver Meeting 2011

Bristol-Myers Squibb Company announced today that 22 abstracts on the Company's research in liver disease have been accepted for presentation at The Liver Meeting 2011, the 62nd annual meeting of the American Association for the Study of Liver Diseases, in San Francisco, November 4 - 8.

1 Oct 2011

Matrix receives FDA's tentative approval for novel co-packaged version of HIV/AIDS therapy

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.

21 Sep 2011

FDA approves Gilead's Complera for treatment of HIV-1 infection

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.

11 Aug 2011

Janssen presents EDURANT 96-week Phase 3 trial data at International AIDS Society Conference

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.

20 Jul 2011

ISENTRESS demonstrates comparable efficacy to efavirenz in treatment-naïve adult HIV-1 patients

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.

18 Jul 2011

Hepatitis B virus rebound common in patients receiving nucleoside analogs for chronic hepatitis B

A rebound of the Hepatitis B virus is common in patients receiving nucleoside analogs for chronic hepatitis B, according to a study from U-M hepatologists. But nearly 40% of the rebounds or virological breakthroughs (VBTs) were not related to antiviral drug resistance.

28 Apr 2011

Study shows possibility of women living with AIDS to breastfeed with lower risk

In low-income countries, 1.4 million women are living with the Aids virus. If no prevention measures are taken, the risk for future mothers of transmitting HIV to their child in utero, during delivery or when breastfeeding is 35%.

20 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

Treatment for HBV infection with entecavir followed by lamivudine results in virologic rebound

A two-year trial of entecavir followed by lamivudine (LAM) in patients with chronic hepatitis B virus (HBV) infection resulted in a virologic rebound rate of 24% and 12% drug-resistance rate. Patients who continued on entecavir therapy throughout the study period had undetectable HBV DNA at the two-year endpoint. Details of this trial are published in the April issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.