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HIV prevention, treatment highlighted at Conference on Retroviruses and Opportunistic Infections

Today was the last day of the 18th Conference on Retroviruses and Opportunistic Infections, a key HIV/AIDS research meeting being held at the Hynes Convention Center in Boston from February 27 through March 2. Highlighted below are selected presentations from March 2nd on research supported by the National Institute of Allergy and Infectious Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, both components of the National Institutes of Health.

5 Mar 2011

Pediatrician unveils latest findings of IMPAACT HIV/AIDS study during 2011 CROI

A clinical study of anti-HIV/AIDS medicines in the developing world is on the verge of turning "the whole treatment world on its head," according to Dartmouth pediatrician Paul Palumbo.

4 Mar 2011

Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV

Shionogi-ViiV Healthcare, LLC announced today that the first patient has entered the clinical study, SINGLE (ING114467), designed to support a new fixed-dose combination (FDC) therapy for the treatment of HIV.

3 Feb 2011

Tibotec grants multiple non-exclusive licenses to generic manufacturers for rilpivirine hydrochloride

Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naive HIV-1 infected adults.

28 Jan 2011

Matrix enters licensing agreement with Tibotec for generic Rilpivirine Hydrochloride

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has signed an agreement with Tibotec Pharmaceuticals for a non-exclusive license to manufacture, market and distribute a generic version of the non-nucleoside reverse transcriptase inhibitor Rilpivirine Hydrochloride (TMC278), pending its regulatory approval for the treatment of treatment-naive HIV-1-infected adults.

28 Jan 2011

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine and Zidovudine Tablets, 30 mg/60 mg.

20 Jan 2011

Merck announces initial results from ISENTRESS Phase III study in HIV-1

Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.

29 Nov 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

Gilead Sciences, Inc. today announced new data from the open-label phase of two pivotal Phase III clinical trials (Studies 102 and 103) evaluating the four-year efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection.

1 Nov 2010

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

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

WHO revises treatment protocols for HIV patients

Prompted by clinical research into the early initiation of antiretroviral therapies for HIV performed at the GHESKIO clinic in Port-au-Prince, Haiti, the World Health Organization (WHO) has revised its treatment protocols for HIV patients.

3 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

Long-term entecavir therapy suppresses HBV DNA, normalizes ALT and improves liver histology

Researchers from this international study found that patients with chronic hepatitis B virus (HBV) infection who received at least 3 years of cumulative entecavir (antiviral) therapy achieved substantial histologic improvement and regression of fibrosis or cirrhosis. Full details of the study appear in the September issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

18 Aug 2010

Long-term Entecavir therapy reverses fibrosis and cirrhosis in chronic hepatitis B patients

17 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

VBDS secondary to nevirapine use in HIV-positive, pregnant female: Report

Vanishing bile duct syndrome refers to a group of disorders characterized by destruction and disappearance of intrahepatic (inside the liver) bile ducts. Multiple causes have been identified including infections, malignancies, autoimmune conditions and adverse effects of medications. The usual course of this condition is variable and many patients with VBDS respond to treatment of the underlying condition and/ or removal of the offending agent. However, others progress to cirrhosis and end stage liver disease requiring liver transplantation.

31 Jul 2010