Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in Europe (Viread HBV PASS)

Study identification

• EU PAS number:
  EUPAS18825
• Study ID:
  27926
• Official title and acronym:
  Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in Europe (Viread HBV PASS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Bulgaria

  France

  Greece

  Italy

  Romania

  Spain

  United Kingdom
• Study description:
  GS-EU-174-1403: The study was a prospective cohort comprised of HBV infected adolescents who initiated Tenofovir DF therapy in clinics across Europe. The subjects were assigned to one of two monitoring groups using a validated computer-generated tool for randomization. Subjects were assigned to Group 1 or 2 upon enrollment into the study but prior to Baseline laboratory and DEXA imaging assessments.Group 1 received Tenofovir DF for the treatment of CHB infection, followed over 96 weeks using an enhanced monitoring protocol which included more frequent laboratory bone biomarker testing and lumbar spine and whole-body DEXA scans than specified for Group 2. With the exception of an enhanced monitoring protocol for bone and renal outcomes, subjects were managed according to local standards of care.Group 2 was the comparator group of subjects receiving Tenofovir DF for the treatment of CHB infection and with the exception of pre-specified bone monitoring, managed according to local standards of care. Group 2 received bone biomarker testing, lumbar spine and wholebody DEXA at Baseline, Weeks 48 and 96.Both groups were monitored for 96 weeks on Tenofovir DF during clinic visits for response to treatment, AEs, adherence to supplementary vitamins and mineral intake assessments. Both groups were be required to have DEXA (whole body and spine) scans for BMD at Baseline (week 0) and prior to receipt of Tenofovir DF, and at the end of the study period (Week 96). Group 2 was a comparator cohort to Group 1 in evaluating the hypothesis of whether enhanced monitoring for renal and BMD changes and AEs provided a net benefit in preventing renal- or bone-related adverse outcomes to adolescents receiving Tenofovir DF therapy for HBV.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 21 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:05/01/2015

Actual:05/01/2015

Study start date

Planned:30/06/2015

Actual:03/07/2015

Date of interim report, if expected

Actual:23/01/2017

Date of final study report

Planned:03/09/2019

Actual:25/09/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Europe Limited

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

This is an interventional study involving two assigned monitoringgroups of chronic HBV infected adolescents who will receivetreatment with open-label, market-authorized Tenofovir DF andfollowed prospectively to a primary endpoint at 96 weeks.