FDA Clinical Inspection Summary: Epclusa (Gilead Sciences)

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Epclusa (sofosvubir/velpatasvir) submitted by Gilead. Eight clinical sites plus the sponsor were inspected. Site inspection ranged from three to six days and the sponsor inspection lasted one week. Sites were primarily selected based on high enrollment across multiple protocols. Three sites received a classification of "Voluntary Action Indicated".

FDA noted issues at Dr. Ngyuen's site for the following:

  • Failing to record all concomitant medications for two subjects on the case report forms (CRFs)
  • Enrolling a subject whose partner was pregnant, contrary to protocol inclusion/exclusion criteria. (FDA notes that the investigator discussed this with the sponsor medical monitor, documented a protocol deviation and reported it to the IRB prior to the FDA inspection.)
  • Respiratory rates required by the protocol were missing from electronic progress notes at least eighty times.

FDA noted the following issues at Dr. Dore's site:

  • Failing to obtain protocol required baseline images within protocol defined timeframes for two subjects

Dr. Younes received a FDA Form 483 for failing to follow the investigational plan, specifically:

  • Enrolling an ineligible subject
    • Did not meet disease history criteria as the protocol required six months and medical records only supported one month with the disease
    • The central lab flagged potential illegal drug use (oxycodone) which the PI stated had been prescribed but there was no substantiating documentation
    • The subject reported drinking 5 to 15 drinks per week on a social history questionnaire, but source documents indicated that the subject drank a six pack per day