August ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.

August 2018

Drug Safety Communications

  • The US FDA is warning that azithromycin should not be given long-term to prevent bronchiolitis obliterans syndrome (BOS) in patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) for hematological malignancy. This alert follows the early termination of a trial investigating the efficacy of long-term azithromycin for preventing BOS after an increased risk of relapse and death was observed in patients taking azithromycin compared with placebo. A plausible mechanism has not been identified. The full Drug Safety Communication can be found here.

New Drug Approvals

  • Arakoda (tafenoquine), approved for malaria prophylaxis in patients aged 18 and older. The recommended dosage is a loading regimen of 200 mg once daily for each of the three days before travel to a malarious area, a maintenance regimen of 200 mg once weekly while in the malarious area (starting seven days after the last loading regimen dose), and then 200 mg (a single dose) in the week following exit from the malarious area (seven days after the last maintenance dose). Product availability: 100 mg tablets.
  • Krintafel (tafenoquine)*, approved for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 and older. The recommended dosage is a single 300 mg dose coadministered on the first or second day of appropriate therapy for acute P. vivax malaria. Product availability: 150 mg tablets.
  • Symtuza* (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg), approved for the treatment of HIV-1 infection in adults who are 1) treatment naive, or 2) virologically suppressed on an ARV regimen for at least 6 months and have no known substitutions associated with darunavir or tenofovir resistance. The recommended dosage is one tablet once daily with food.
  • TPOXX (tecovirimat)*, approved for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg. Clinical studies in humans have not been conducted; the effectiveness of tecovirimat was established based on animal efficacy studies. The drug works by inhibiting the orthopoxvirus VP37 envelope wrapping protein. Recommended dosage in patients weighing ≥40 kg is 600 mg (three 200 mg capsules) po bid for 14 days. Pediatric dosage: weight 13 to <25 kg, 200 mg bid; 25 to <40 kg, 400 mg bid.

New or Updated Treatment Guidelines

  • Updated recommendations regarding the use of antiretroviral drugs for treatment and prevention of HIV infection in adults, from the International Antiviral Society-USA (IAS-USA) Panel (Saag MS et al, JAMA 320:379, 2018). These recommendations update the 2016 version and are available on the JAMA website.
  • Updated recommendations regarding testing and monitoring for antiretroviral drug resistance in HIV-infected individuals, from the International Antiviral Society-USA (IAS-USA) Panel (Clin Infect Dis 2018 July 20 [Epub ahead of print]). These recommendations update the 2008 version.
  • Belgian guidelines for the screening for latent tuberculosis in HIV-infected patients, from members of the Belgian LTBI group in consultancy with the AIDS Reference Center College (Acta Clin Belg 2018 July 23 [Epub ahead of print]).
  • A summary of the updated guidelines on primary antifungal prophylaxis in adult hematology patients, from The European Conference on Infections in Leukaemia (ECIL). Compared to the 2011 version, major changes include implementation of the IDSA grading system and extension of the recommendations to other hematological diseases besides AML and allogeneic HSCT recipients. This publication summarizes the proposals agreed upon at ECIL-5 and ECIL-6 (J Antimicrob Chemother 2018 Aug 1 [Epub ahead of print]).
  • Updated clinical practice guidelines for the treatment of chronic hepatitis C, from the Korean Association for the Study of the Liver (Clin Mol Hepatol 2018 August 10 [Epub ahead of print]). The last update was in 2015. These guidelines are available on the journal website.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Ciprofloxacin 0.3% ophthalmic solution
    • [Shortage recently resolved]: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment, Tobramycin injection
      • Cephalosporins: Cefazolin, Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Cefpodoxime oral suspension, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Gemifloxacin tablets, Moxifloxacin injection (unavailable)
      • Penicillins: Ampicillin/sulbactam, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Clindamycin injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension, Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: None
      • Vaccines: Hepatitis A virus vaccine inactivated (Vaqta), Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)