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.

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections.

30 Jul 2015

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration's tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.

5 Jun 2015

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib.

1 Jun 2015

Janssen, Bayer HealthCare initiate CALLISTO program to study rivaroxaban in patients with active cancer

Janssen Pharmaceuticals, Inc. and its development partner, Bayer HealthCare, today announced the initiation of CALLISTO, a new comprehensive clinical research program for their novel oral anticoagulant, rivaroxaban, in patients with active cancer. The studies are evaluating the medicine for the prevention and treatment of life-threatening blood clots in patients with a wide range of cancer types.

28 May 2015

AbbVie announces new results from Phase 3 GIFT-I study in GT1b HCV infected Japanese patients

AbbVie presented new results from the Phase 3 GIFT-I study of its investigational, all-oral, interferon (IFN)- and ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.

27 May 2015

AbbVie's all-oral, interferon-free therapy granted FDA priority review for treatment of GT4 HCV infection

AbbVie has announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV).

25 Apr 2015

Japanese MHLW grants priority review for AbbVie's investigational hepatitis C treatment

AbbVie today announced that the Japanese Ministry of Health, Labour and Welfare has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir.

16 Apr 2015

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).

8 Mar 2015

MPP, MSD sign licensing agreement for paediatric formulations of raltegravir

The Medicines Patent Pool announced a licence today with MSD, known as Merck in the United States and Canada, for paediatric formulations of raltegravir, a key medicine approved for children living with HIV four weeks of age and older.

24 Feb 2015

AbbVie submits NDA in Japan for investigational, all-oral treatment of patients with chronic HCV infection

AbbVie (NYSE: ABBV) submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the company's investigational, all-oral, ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily.

12 Feb 2015

AbbVie releases Phase 3 results from all-oral OBV/PTV/r treatment for GT1b chronic HCV infection

AbbVie released top-line Phase 3 results for its investigational, all-oral, ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan.

31 Jan 2015

AbbVie gets European Commission's approval to market VIEKIRAX + EXVIERA for HCV treatment

AbbVie announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets). The treatment has been approved with or without ribavirin (RBV) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.

16 Jan 2015

Janssen, Gilead to jointly develop darunavir-based, single-tablet regimen for HIV treatment

Janssen R&D Ireland announced today an amendment to its existing agreement with Gilead Sciences, Inc., initially established in 2011, for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of people living with HIV.

29 Dec 2014

Abbvie’s HOLKIRA PAK for chronic genotype 1 Hepatitis C treatment receives Health Canada approval

AbbVie receives Health Canada approval for HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets), an all-oral, short-course (12 weeks for the majority of patients), interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with cirrhosis.

23 Dec 2014

FDA approves AbbVie's VIEKIRA PAK for treatment of patients with GT1 HCV infection

The U.S. Food and Drug Administration has approved AbbVie's VIEKIRA PAK, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis.

21 Dec 2014

Auxilium Pharmaceuticals presents STENDRA clinical data for ED treatment at SMSNA Scientific Meeting

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that data were presented regarding the use of STENDRA® (avanafil) tablets for the treatment of erectile dysfunction (ED) at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) held in Miami from November 20-23, 2014.

20 Nov 2014

Three-drug regimen taken during pregnancy prevents mother-to-child HIV transmission

For HIV-infected women in good immune health, taking a three-drug regimen during pregnancy prevents mother-to-child HIV transmission more effectively than taking one drug during pregnancy, another during labor and two more after giving birth, an international clinical trial has found.

19 Nov 2014

Novel method could improve treatment for infants, young children suffering from HIV/AIDS

A novel method of altering a protein in milk to bind with an antiretroviral drug promises to greatly improve treatment for infants and young children suffering from HIV/AIDS, according to a researcher in Penn State's College of Agricultural Sciences.

12 Nov 2014

MSD announces Phase 2b results of doravirine therapy in untreated patients with HIV-1 infection

Merck Sharp & Dohme Ltd. MSD (known as Merck & Co., Inc. in the United States and Canada), today announced the presentation of results from a Phase 2b clinical trial evaluating the safety and efficacy of once daily oral doravirine, an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), plus tenofovir/emtricitabine (TDF/FTC) compared to efavirenz plus TDF/FTC in previously untreated patients with HIV-1 infection.

4 Nov 2014

Janssen announces availability of PREZCOBIX for Canadians living with HIV

Janssen Inc. announced today that PREZCOBIX (darunavir/cobicistat), a once-daily, oral medication for the treatment of HIV infection in combination with other antiretroviral agents, is now available in Canada. It is the first HIV treatment option available to patients that provides boosted darunavir in a single tablet.

17 Sep 2014