- Subject has documented vaccination to hepatitis A virus (HAV) and hepatitis B virus (HBV), or has received the first dose of HAV and HBV vaccine prior to the first dose of investigational drug and is scheduled to receive the second vaccine dose. If subject has documented vaccination more than 1 year before screening but has a negative antibody titer to HAV and/or HBV at screening, subject is required to begin a re-vaccination series with the first dose of HAV and/or HBV vaccine prior to the first dose of investigational drug and is scheduled to receive the second vaccine dose. No revaccination is required if the documented vaccination took place within 1 year of screening.