HAVEN. HCV/HIV PASS Study. Harvoni with TDF+PK enhancers.
Research type
Research Study
Full title
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
IRAS ID
212274
Contact name
Stephen Ryder
Contact email
Sponsor organisation
Gilead Sciences
Clinicaltrials.gov Identifier
EU PAS Register no, ENCEPP/ EUPAS14114; Procedure number, EMEA/H/C/3850
Duration of Study in the UK
2 years, 10 months, 16 days
Research summary
This is an Observational (i.e. patients will not have any tests or procedures other than normal practice of care) Post-authorisation Safety Study. Across 10 European Union (EU) Countries, the study plans to recruit 2000 adults co-infected with chronic Hepatitis C Virus (HCV) & Human Immunodeficiency Virus (HIV), who are receiving any HIV treatment regimen & initiate treatment with Harvoni. Harvoni is approved in the EU for the treatment of HCV infection in adults & the study is funded by Gilead -the Marketing Authorisation Holder for Harvoni. Following Informed consent, data from Medical records will be collected at the initiation of Harvoni treatment, during treatment and 4 weeks after treatment.
HCV infection can lead to serious liver problems, including cirrhosis or cancer. An important potential risk in the Harvoni EU Risk Management Plan is a Drug-drug interaction between Harvoni with certain HIV antiretroviral (ARV) regimens containing a drug called tenofovir disoproxil fumarate (TDF) taken together with a pharmacokinetic (PK) enhancer (drug that acts like a booster).
HIV Patients tend to take three or more types of ARV’s & TDF use is common. Monitoring of kidney (renal) function is recommended in patients taking TDF as a safety precaution. Worldwide, there are 4-5 million people co-infected with HCV and HIV. In Europe, approximately 25% of HIV patients are co-infected with HCV. Harvoni may be taken for 8, 12 or 24 weeks and the short treatment duration may reduce any TDF-associated renal toxicity. However, the frequency of co-administration of Harvoni with TDF+PK enhancer is currently unknown.
This study aims to: A) characterize the frequency of co-administration of Harvoni with TDF + PK enhancers in the post-marketing setting.
B) Characterize all renal adverse events and renal function testing in concomitant users of Harvoni and TDF+PK enhancers.REC name
North of Scotland Research Ethics Committee 1
REC reference
16/NS/0140
Date of REC Opinion
17 Jan 2017
REC opinion
Further Information Favourable Opinion