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Journal Cover   The Medical Letter
  [SJR: 0.142]   [H-I: 16]   [5 followers]  Follow
   Full-text available via subscription Subscription journal
   ISSN (Print) 0025-732X - ISSN (Online) 1523-2859
   Published by The Medical Letter, Inc Homepage  [1 journal]
  • Cobicistat (Tybost) and Combinations for HIV
    • Authors: admin
      Abstract: Date:  November 23, 2015 Issue #:  1482 Summary:  Cobicistat, a pharmacokinetic enhancer that boosts levels of some HIV drugs but has no antiretroviral activity of its own, is now available alone as Tybost (Gilead) and in fixed-dose combinations with the protease inhibitors atazanavir (Evotaz — BMS) and darunavir (Prezcobix — Janssen) for treatment of HIV-1 infection. Both atazanavir and darunavir have traditionally been used in combination with the CYP3A inhibitor ritonavir (Norvir) to boost their serum concentrations, but neither is available in a fixed-dose combination with ritonavir.
      PubDate: Wed, 04 Nov 2015 13:06:07 +000
  • In Brief: Technivie for HCV Genotype 4 Infection (online only)
    • Authors: admin
      Abstract: Date:  November 23, 2015 Issue #:  1482 Summary:  The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic hepatitis C virus (HCV) genotype 4 infection in patients without cirrhosis. It is indicated for use in combination with ribavirin. Ombitasvir/paritaprevir/ritonavir copackaged with dasabuvir, an HCV RNA polymerase inhibitor that has little activity against HCV genotype 4, is approved as Viekira Pak for treatment of HCV genotype 1 infection.1

      HCV genotype 4 is uncommon in the US and Canada. It is the most prevalent strain of HCV in Central sub-Saharan Africa, North Africa, and the Middle East.2 Technivie plus ribavirin was the first all-oral treatment approved for treatment of HCV genotype 4. Ledipasvir/sofosbuvir (Harvoni)3 was also recently approved for this indication; it does not require coadministration with ribavirin and can be used in patients with or without cirrhosis. Its use for this and other new indications will be reviewed in a future issue.

      FDA approval of Technivie was based on an open-label trial (PEARL-I) in 86 treatment-naive and 49 treatment-experienced non-cirrhotic patients with HCV genotype 4 infection. Treatment-naive patients were randomized to receive Technivie with or without ribavirin for 12 weeks; all treatment-experienced patients received the combination plus ribavirin for 12 weeks. The rate of sustained virologic response 12 weeks after stopping treatment (SVR12), the primary endpoint, was 91% (40/44) in treatment-naive patients not receiving ribavirin and was 100% in both treatment-naive (42/42) and treatment-experienced (49/49) patients receiving the combination plus ribavirin.4

      Adverse effects observed with Technivie in the clinical trial included asthenia, fatigue, nausea, insomnia, pruritus, and skin reactions. Like Viekira Pak, Technivie has been associated with serious, sometimes fatal cases of hepatic decompensation and is contraindicated in patients with moderate to severe (Child-Pugh B/C) hepatic impairment.5 It is also contraindicated in patients taking ethinyl estradiol (because of a risk of ALT elevation), CYP3A4 inducers such as rifampin, or certain sensitive CYP3A4 substrates such as midazolam or simvastatin.6

      Each Technivie tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir, and 50 mg of ritonavir. The recommended dosage is two tablets taken once daily in the morning with a meal for 12 weeks. Ribavirin should be coadministered with Technivie at a daily dose of 1000 mg in patients weighing <75 kg or 1200 mg in those weighing ≥75 kg. Use of Technivie alone may be considered in treatment-naive patients who cannot take or tolerate ribavirin. A 12-week supply of Technivie costs $76,653.7

      A 4-drug combination (Viekira Pak) for hepatitis C. Med Lett Drugs Ther 2015; 57:15.
      JP Messina et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 2015; 61:77.
      A combination of ledipasvir plus sofosbuvir (Harvoni) for hepatitis C. Med Lett Drugs Ther 2014; 56:11.
      C Hézode et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet 2015; 385:2502.
      In brief: hepatic injury with hepatitis C drugs. Med Lett Drugs Ther 2015; 57:156.
      Inhibitors and inducers of CYP enzymes and P-glycoprotein. Med Lett Drugs Ther 2013; 55:e44.
      Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. November 5, 2015. Reprinted with permission by First Databank, Inc. All rights reserved. ©2015

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      PubDate: Wed, 04 Nov 2015 13:05:39 +000
  • Tiotropium/Olodaterol (Stiolto Respimat) for COPD
    • Authors: admin
      Abstract: Date:  November 23, 2015 Issue #:  1482 Summary:  The FDA has approved a fixed-dose, orally inhaled combination of the long-acting anticholinergic tiotropium and the long-acting beta2-adrenergic agonist olodaterol (Stiolto Respimat — Boehringer Ingelheim) for long-term, once-daily, maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Tiotropium (Spiriva Handihaler, Spiriva Respimat) and olodaterol (Striverdi Respimat) are also available separately for once-daily treatment of COPD.
      PubDate: Wed, 04 Nov 2015 13:05:07 +000
  • Bexsero - A Second Serogroup B Meningococcal Vaccine
    • Authors: admin
      Abstract: Date:  November 23, 2015 Issue #:  1482 Summary:  The FDA has approved Bexsero (Novartis/GSK), a vaccine that protects against invasive meningococcal disease caused by Neisseria meningitidis serogroup B. It is the second serogroup B meningococcal vaccine to be approved in the US; Trumenba was the first. Both vaccines are approved for use in persons 10-25 years old. Bexsero is approved in Europe, Canada, and Australia for use in children as young as 2 months old.
      PubDate: Wed, 04 Nov 2015 13:04:26 +000
  • Idarucizumab (Praxbind) - An Antidote for Dabigatran
    • Authors: admin
      Abstract: Date:  November 23, 2015 Issue #:  1482 Summary:  The FDA has approved idarucizumab (Praxbind – Boehringer Ingelheim) for urgent reversal of the anticoagulant effect of the direct thrombin inhibitor dabigatran etexilate (Pradaxa). Idarucizumab is the first specific reversal agent to become available for one of the new oral anticoagulants.
      PubDate: Wed, 04 Nov 2015 13:03:42 +000
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