The US Food and Drug Administration (FDA) has approved HEPLISAV-B [Hepatitis B vaccine, recombinant (adjuvanted)] for the prevention of hepatitis B infection in adults.
Indications: HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. It is approved for use in adults aged ≥18 years.
Dosage and administration: Administer 2 doses (0.5 mL each) intramuscularly 1 month apart.
Safety/efficacy: The approval of HEPLISAV-B was based on data from 3 phase 3 noninferiority trials of nearly 10,000 adult participants who received HEPLISAV-B showing a protection rate of 95%.
Adverse reactions: The most common local reaction was injection site pain (23%-39%). The most common systemic reactions were fatigue (11%-17%) and headache (8%-17%).
Dynavax announces FDA approval of HEPLISAV-B for prevention of hepatitis B in adults. [news release]. Berkeley, CA: Dynavax Technologies Corp. November 9, 2017. http://files.shareholder.com/downloads/DVAX/5565233375x0x963690/63F50A98.... Accessed November 14, 2017.
This Week's Must Reads
Antibiotic Use and Hospital Onset CDI Infection, Clin Infect Dis; ePub 2019 Mar 1; Kazakova, et al
Sex Discrepancies in OAT Effect on Incident HCV, Clin Infect Dis; ePub 2019 Feb 28; Geddes, et al
HIV Practitioners’ Recommend Condom Use in HIV, Open Forum Infect Dis; ePub 2019 Feb 21; Schreier, et al
Must Reads in FDA Actions
FDA Approves Firvanq for C.diff-associated Diarrhea, CutisPharma news release; 2018 Jan 29
FDA Expands Indication for Influenza Vaccine, GSK news release; 2018 Jan 11
FDA Approves Isentress for Tx of HIV in Newborns, Merck news release; 2017 Nov 29
FDA Approves First 2-Drug Regimen for HIV, FDA news release; 2017 Nov 21
FDA Approves Two-Dose Hep B Vaccine , Dynavax news release; 2017 Nov 9