Ritonavir News and Research

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Ritonavir, also known as Norvir, is a type of medicine called a protease inhibitor (PI). PIs act by blocking protease, a protein that HIV needs to make more copies of itself. Ritonavir was approved by the FDA on March 1, 1996, for use with other antiretroviral agents in the treatment of HIV infection in adults and children 2 years of age or older. Ritonavir is now approved with other anti-HIV drugs in the treatment of HIV-1 infection in children in individuals over 1 month in age. Studies have shown that ritonavir works as a booster for some other PIs. Taking ritonavir makes it possible to take a lower dose of the other PIs. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.

Abstracts on Bristol-Myers Squibb's research in liver disease accepted for presentation

Bristol-Myers Squibb Company announced today that 14 abstracts on the Company's research in liver disease have been accepted for presentation at The International Liver CongressTM 2013, the 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam, April 24 - 28.

8 Apr 2013

Medivir seeks FDA approval for simeprevir

Medivir AB today announced that a new drug application has been filed with the U.S. Food and Drug Administration seeking approval for simeprevir.

30 Mar 2013

Indonesia to issue compulsory licenses for HIV, hepatitis B drugs still under patent

"The Indonesian government hopes to implement one of the largest ever examples of 'compulsory licensing,' which will enable the generic manufacture of drugs still under patent," IRIN reports.

27 Mar 2013

Discovery provides clues for potentially eliminating HIV infection in children

A two-year-old child born with HIV infection and treated with antiretroviral drugs beginning in the first days of life no longer has detectable levels of virus using conventional testing despite not taking HIV medication for 10 months, according to findings presented today at the Conference on Retroviruses and Opportunistic Infections in Atlanta.

5 Mar 2013

HCV and HIV co-infected patients achieve early treatment success with faldaprevir, PegIFN/RBV

Interim study results from STARTversoTM 4 presented today at CROI+ show that 80 percent of hepatitis C (HCV) patients also infected with HIV achieved early treatment success with faldaprevir (BI 201335) combined with pegylated interferon and ribavirin (PegIFN/RBV).

5 Mar 2013

Janssen submits simeprevir regulatory application in Japan to treat HCV

Medivir AB today announced that its partner Janssen now has submitted a regulatory application to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, prior non responders or relapsed following treatment with Peg-IFN with or without RBV.

22 Feb 2013

Gilead Sciences fourth quarter total revenues increase 18% to $2.59 billion

Gilead Sciences, Inc. announced today its results of operations for the fourth quarter and full year 2012.

5 Feb 2013

Janssen, Medivir and Idenix partner for clinical development of HCV combination therapy

Medivir AB today announced a non-exclusive collaboration between Janssen Pharmaceuticals Inc. (Janssen) and Idenix Pharmaceuticals for the clinical development of an all-oral (interferon-free) direct-acting antiviral (DAA) hepatitis C (HCV) combination therapy.

29 Jan 2013

Gilead commences first of two tenofovir alafenamide Phase 3 trials in HIV

Gilead Sciences, Inc. today announced the initiation of the first of two Phase 3 clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.

28 Jan 2013

Janssen receives EC approval for PREZISTA 800mg tablet to treat HIV

Janssen R&D Ireland announced today that the European Commission (EC) has approved a new PREZISTA (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day.

16 Jan 2013

Bristol-Myers Squibb, Pfizer receive FDA approval for ELIQUIS to reduce risk of stroke and SE

Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved ELIQUIS (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

2 Jan 2013

Top-line results from Medivir's simeprevir phase III trials on genotype 1 HCV infection

Medivir AB today announced top-line results from three pivotal phase III trials examining the one pill, once-daily, investigational protease inhibitor, simeprevir (TMC435), administered with pegylated interferon and ribavirin.

20 Dec 2012

Medivir commences cohort 2 simeprevir and sofosbuvir phase II combination trial in HCV GT1

Medivir AB, announced today the initiation of cohort 2 in the interferon-free phase II trial combining simeprevir with sofosbuvir (GS7977) based on a safety and efficacy planned interim analysis of cohort 1 including prior null responder HCV genotype 1 infected patients without advanced hepatic fibrosis.

13 Dec 2012

Janssen receives positive opinion from EMA CHMP for ZYTIGA to treat mCRPC

Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of the oral, once-daily medication ZYTIGA for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

19 Nov 2012

Abbott releases details on phase 3 hepatitis C registrational program

Abbott today released details on its phase 3 hepatitis C registrational program following promising results from its phase 2b clinical trial, known as Aviator, presented at the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston.

13 Nov 2012

Phase II study to evaluate Medivir/Janssen's simeprevir and Vertex against HCV

Medivir AB, announced today plans for a phase II proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing of Medivir/Janssen's protease inhibitor simeprevir and Vertex's nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135.

3 Nov 2012

Janssen, Vertex to evaluate TMC435 and VX-135 in Phase 2 HCV study

Janssen Pharmaceuticals, Inc. today announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals Incorporated to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen for the treatment of hepatitis C (HCV).

2 Nov 2012

Encouraging results from Gilead’s TAF Phase 2 trial on HIV-1 infection

Gilead Sciences, Inc. today announced that a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate, an investigational novel prodrug of tenofovir for the treatment of HIV-1 infection, met its primary objective.

1 Nov 2012

Medivir’s simeprevir and TMC647055 to enter phase IIa combination trial for HCV genotype-1

Medivir AB, announced today that simeprevir (TMC435) and TMC647055, a non-nucleoside inhibitor (NNI) will enter a phase IIa interferon free combination trial.

21 Sep 2012

FDA approves Gilead’s Stribild to treat HIV-1 infection

The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.

28 Aug 2012