Gilead

FDA Clinical Inspection Summary: Bictarvy submitted by Gilead

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 Bictarvy submitted by Gilead. Five sites were selected for inspection based on treatment effect, financial disclosure and prior inspection history. One site received a FDA Form 483.

Dr. Charest was cited for:

  • Failing to provide a participant with an updated consent form. FDA notes that the participant was provided with a consent form for a different study and notes that procedures performed on Week 60 and Week 72 were performed without appropriate consent.

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

 

FDA Clinical Inspection Summary for Genvoya by Gilead

FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the drug approval archives, here is the Clinical Inspection Summary for Gilead's Genvoya (elvitegravir; cobicistat; emtricitabine; tenofovir alafenamide). Eight clinical sites were inspected across two clinical studies. Site inspections ranged from three days to two weeks. FDA selected sites based on the following criteria:  

1) Enrollment of a relatively large number of subjects with a treatment effect that was greater than average

2) Sites that participated in both pivotal studies as well as participating in the switch study

3) The need to determine if sites conducted the trials ethically and were in compliance with GCP regulation and local requirements.

Two sites received 483s.

Dr. Chetchotisakd received a 483 for:

  • Enrolling a subject prior to assessing the genetic testing required for eligibility.
  • Enrolling a subject who was not eligible for the trial due to the genetic test results.

Dr. Benson received a 483 for failing to follow the investigational plan, specifically:

  • Repeat urinalysis was not conducted as required by protocol for two subjects
  • Four subjects experienced adverse events that were not reported per protocol (scattered joint pain, vomiting, lightheadedness, diarrhea)