Zidovudine News and Research

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Zidovudine was approved by the FDA on March 19, 1987, with other antiretroviral agents for the treatment of HIV infection in adults and in children 3 months of age or older. This medicine is also approved for use in HIV infected women to prevent the virus from being passed to their babies during pregnancy and delivery. It is then given to these babies for the first 6 weeks of life. Although the FDA does not approve this practice, zidovudine may be used to prevent workers from getting HIV infection after they accidentally come into contact with the virus on the job. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.

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

Amgen announces voluntary recall of certain lots of EPOGEN and PROCRIT

Amgen announced today that certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product.

24 Sep 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

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

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

11 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

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.

26 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Maternal, infant ART drives down mother-to-child HIV transmission through breast-feeding, studies show

According to two new studies, "giving pregnant and nursing women triple antiretroviral drug therapy, or treating breast-fed infants with an antiretroviral medication, can dramatically cut transmission rates, enabling moms to both breast-feed and to protect nearly all children from infection," HealthDay News/Bloomberg Businessweek reports (Goodwin, 6/16).

18 Jun 2010

Infant nevirapine more effective in preventing HIV transmission than maternal antiretroviral therapy

The largest study to date to examine methods to prevent HIV infection among breastfeeding infants concludes that giving antiretroviral drugs to HIV-infected breastfeeding mothers in sub-Saharan Africa or giving an HIV-fighting syrup to their babies are both effective.

17 Jun 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

ViiV Healthcare highlights S/GSK1349572, SELZENTRY and EPZICOM for HIV/AIDS at 17th CROI

At the 17th Conference on Retroviruses and Opportunistic Infections (CROI), ViiV Healthcare presented new data across its broad range of investigational and current medicines for the treatment of HIV/AIDS. Highlighted data at the conference included an oral presentation on the investigational integrase inhibitor, S/GSK1349572, as well as data presentations on SELZENTRY® (maraviroc) and EPZICOM® (abacavir/lamivudine).

24 Feb 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

Amgen and Centocor Ortho Biotech Products: FDA approves REMS for Aranesp, EPOGEN and PROCRIT ESAs

Amgen Inc. and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa) and PROCRIT® (Epoetin alfa).

17 Feb 2010

New findings would allow doctors to tailor drug cocktails for particular viral strains

Chemists at UC San Diego and statisticians at Harvard University have developed a novel way to trace mutations in HIV that lead to drug resistance. Their findings, once expanded to the full range of drugs available to treat the infection, would allow doctors to tailor drug cocktails to the particular strains of the virus found in individual patients.

12 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