Adverse reactions to Hepatitis C drugs

Drug hypersensitivity reactions to direct acting hepatitis C virus antiviral drugs

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618001740280

Enrollment

108

Registered

2018-10-23

Start date

2018-11-14

Completion date

2020-11-14

Last updated

2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Adverse reactions to direct acting antiviral medications to treat hepatitis C have occurred in some people. These adverse reactions include damage to the liver. The aim of this project is to study the genetic association of these cases of adverse reactions. People that have had direct acting antiviral medications to treat hepatitis C and have had a hypersensitivity reaction will be compared to those that have had direct acting antiviral medications to treat hepatitis C and have not had a hypersensitivity reaction. The study will require people to supply buccal tissue samples so that identification of potential genetic association can be established through DNA testing. This may help predict which people are sensitive to these antiviral drugs and therefore prevent sever reactions. These DNA samples will be destroyed after the genetic testing has been completed.

Interventions

The aim of this project is to investigate the underlying genetic mechanism of cases of adverse reactions to direct acting antiviral drugs used to treat Hepatitis C. People on the study will be asked to supply buccal tissue samples (DNA) so that whole genomic analysis will identify potential genetic associations. This may help predict which people are sensitive to these antiviral drugs and therefore prevent severe reactions. Those people with demonstrated hypersensitivity reactions to direct acting antiviral medication will be compared to people treated with direct acting antiviral drugs that have not had a reaction. After the initial recruitment and enrolment visit, there will be no follow up - information obtained will be included in a National drug allergy registry.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of drug hypersensitivity reaction (HSR) confirmed using: • Modified European Network of Drug Allergy (ENDA) drug allergy questionnaire. • Severe Cutaneous Adverse Reactions (SCAR) to drugs criteria. • Idiosyncratic drug-induced liver injury (iDILI) criteria. • Clinical severity. • Direct acting antiviral drug treatment at time of hypersensitivity reaction. • Laboratory parameters: liver function test, total bilirubin. • Informed consent for health information acquisition, DNA bio-sample (buccal swab).

Exclusion criteria

• People under the age of 18years. • Females that are pregnant. • Those people not willing to give consent.

Outcome results