Study identification

PURI

https://redirect.ema.europa.eu/resource/45930

EU PAS number

EUPAS41657

Study ID

45930

Official title and acronym

Direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection and the risk of hepatocellular carcinoma (HCC) recurrence: A protocol for a systematic literature review

DARWIN EU® study

No

Study countries

United States

Study description

A systematic literature review (SLR) will be conducted to identify and synthesize the evidence from the peer-reviewed published literature on the risk of early HCC recurrence following DAA therapy for chronic HCV infection. The mechanisms and rate of HCC recurrence after DAA treatment are unknown and there is conflicting evidence in the published literature. Following Cochrane, PRISMA 2020, and EMA recommended methodologies, the SLR will provide results among a well-characterized group of adult patients who were treated with DAA therapy for chronic HCV, relative to no DAA therapy, after successful HCC treatment.

Study status

Finalised
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
InstitutionNon-Pharmaceutical companyENCePP partner

Contact details

Jennifer Uyei

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

MAHs of the DAAs Consortium (AbbVie Inc., Gilead Sciences, Inc., and Merck Sharp & Dohme Corp.)
Study protocol
Initial protocol

DAA_Consortium-IQVIA SLR Protocol - EU PAS

English (6.15 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable