GS-EU-337-1820 - An Observational Drug Utilization Study of Ledipasvir/Sofosbuvir and Tenofovir Disoproxil Fumarate + Pharmacokinetic Enhancer Co-Administration in Adults Co-Infected with Chronic Hepatitis C and HIV-1 Infections (HAVEN co-infection study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25605
• EU PAS number:
  EUPAS14114
• Study ID:
  25605
• Official title and acronym:
  GS-EU-337-1820 - An Observational Drug Utilization Study of Ledipasvir/Sofosbuvir and Tenofovir Disoproxil Fumarate + Pharmacokinetic Enhancer Co-Administration in Adults Co-Infected with Chronic Hepatitis C and HIV-1 Infections (HAVEN co-infection study)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Ireland

  Italy

  Poland

  Portugal

  Spain

  Sweden

  United Kingdom
• Study description:
  This non-interventional, prospective drug utilization study will assess the utilization of Harvoni and TDF+PK enhancers among chronic HCV and HIV-1 co-infected patients ≥ 18 years of age that are prescribed Harvoni whilst receiving any HIV treatment regimen in Europe. The objectives of this study are as follows:Primary - To characterize the frequency of co-administration of Harvoni with TDF + PK enhancers in the post-marketing setting.Secondary - To characterize renal adverse events (serious and non-serious) and renal function testing in concomitant users of Harvoni and TDF+PK enhancers.Exploratory - To assess HIV-treatment regimen changes with Harvoni utilization.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 41 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/01/2016

Actual: 05/01/2016

Study start date

Planned: 30/12/2016

Actual: 13/12/2016

Date of interim report, if expected

Actual: 06/07/2017

Date of final study report

Planned: 29/05/2020

Actual: 14/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Europe Limited

Study protocol

Initial protocol

GS-EU-337-1820 Original Protocol 16 March 2016 FINAL

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)