YF_PROTECT: Prophylactic Treatment with Sofosbuvir for Yellow fever Exemption Circumstances and Travel

Conditions

Healthy volunteers

Brief summary

viremia (YF17D virus in plasma) at any time (yes/no), and/ or viruria (YF17D in urine) at any time (yes/no), and/ or neutralizing antibodies on D28 after vaccination (yes/no)

Detailed description

Adverse events of sofosbuvir (diary with an SmPC based symptom questionnaire and reporting of any unsolicited adverse events), Increase in ALT and bilirubin, and decrease in Hb levels on day 5* and 28 after vaccination compared to day 0 in the sofosbuvir treatment group. * For group B this will be done on day 2, do make sure the sample is taken within reasonable time after sofosbuvir use, Differences in ALT, bilirubin and blood count (i.e., haemoglobin, thrombocytes, leukocyte differentiation) between the sofosbuvir treatment and no treatment group, Exploratory endpoint: Plasma is stored for determination of sofosbuvir concentration, which will only be measured when viremia or viruria or yellow fever neutralizing antibodies are not absent/decreased in participants in the sofosbuvir treatment group

Related papers

No related papers found yet.

Interventions

DRUGSovaldi 400 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
viremia (YF17D virus in plasma) at any time (yes/no), and/ or viruria (YF17D in urine) at any time (yes/no), and/ or neutralizing antibodies on D28 after vaccination (yes/no)	—

Secondary

Measure	Time frame
Adverse events of sofosbuvir (diary with an SmPC based symptom questionnaire and reporting of any unsolicited adverse events), Increase in ALT and bilirubin, and decrease in Hb levels on day 5* and 28 after vaccination compared to day 0 in the sofosbuvir treatment group. * For group B this will be done on day 2, do make sure the sample is taken within reasonable time after sofosbuvir use, Differences in ALT, bilirubin and blood count (i.e., haemoglobin, thrombocytes, leukocyte differentiation) between the sofosbuvir treatment and no treatment group, Exploratory endpoint: Plasma is stored for determination of sofosbuvir concentration, which will only be measured when viremia or viruria or yellow fever neutralizing antibodies are not absent/decreased in participants in the sofosbuvir treatment group	—

Measure

Time frame

Adverse events of sofosbuvir (diary with an SmPC based symptom questionnaire and reporting of any unsolicited adverse events), Increase in ALT and bilirubin, and decrease in Hb levels on day 5* and 28 after vaccination compared to day 0 in the sofosbuvir treatment group. * For group B this will be done on day 2, do make sure the sample is taken within reasonable time after sofosbuvir use, Differences in ALT, bilirubin and blood count (i.e., haemoglobin, thrombocytes, leukocyte differentiation) between the sofosbuvir treatment and no treatment group, Exploratory endpoint: Plasma is stored for determination of sofosbuvir concentration, which will only be measured when viremia or viruria or yellow fever neutralizing antibodies are not absent/decreased in participants in the sofosbuvir treatment group

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Countries

Netherlands

Outcome results

None listed