Other safety alerts
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| The United Kingdom: Elvitegravir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that pharmacokinetic data indicate exposure of elvitegravir boosted with cobicistat (Genvoya▼, Stribild) is lower during the second and third trimesters of pregnancy than postpartum. Low elvitegravir exposure may be associated with an increased risk of treatment failure and an increased risk of HIV-1 transmission to the unborn child, and therefore elvitegravir/cobicistat should not be used during pregnancy.
Elvitegravir is an integrase inhibitor that is used as one of the concomitant antiretroviral therapies to treat HIV-1. Cobicistat is a pharmacokinetic enhancer used to increase elvitegravir levels.
In Jul 2018, MHRA issued warnings not to use darunavir boosted with cobicistat in pregnancy after pharmacokinetic data suggested an increased risk of treatment failure and mother-to-child transmission of HIV infection due to lower exposures during pregnancy. The risk in treatments containing elvitegravir/cobicistat has also been reviewed.
Pharmacokinetic data from IMPAACT P1026s (International Maternal Pediatric Adolescent AIDS Clinical Trials P1026 study) show that compared with paired postpartum data, plasma concentration after 24 hours of elvitegravir boosted with cobicistat was 81% lower in the second trimester and 89% lower in the third trimester. Plasma concentration after 24 hours of cobicistat was 60% and 76% lower in the second and third trimester, respectively.
A review of safety data and the published literature has not to date identified any cases of mother to child HIV-1 transmission in women taking regimens containing elvitegravir/cobicistat during the second and third trimesters of pregnancy. However, due to the theoretical risk, therapy with elvitegravir/cobicistat should not be initiated during pregnancy and women who are pregnant and taking elvitegravir/cobicistat should be switched to an alternative regimen.
The product information for Genvoya▼ (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) and Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil) are being updated to recommend against use in pregnancy.
Healthcare professionals are advised:
- Pharmacokinetic data show low exposure values of elvitegravir boosted with cobicistat (elvitegravir/cobicistat) during the second and third trimesters of pregnancy.
- Although no cases have been reported of such transmission on elvitegravir/ cobicistat therapy to date, low elvitegravir exposure may be associated with an increased risk of treatment failure and an increased risk of mother-to-child transmission of HIV infection.
- Therapy with elvitegravir/cobicistat should not be initiated during pregnancy.
- Switch women who are pregnant and taking elvitegravir/cobicistat to an alternative regimen.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/elvitegravir-boosted-with-cobicistat-avoid-use-in-pregnancy-due-to-risk-of-treatment-failure-and-maternal-to-child-transmission-of-hiv-1
In Hong Kong, Stribild Tablets (HK-62550), Stribild Tablets (HK-64384) and Genvoya Tablets (HK-64455) are registered pharmaceutical products containing elvitegravir/cobicistat. These products are registered by Gilead Sciences Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to Genvoya, but this case is not related to treatment failure in pregnancy or maternal-to-child transmission of HIV-1. In light of the above MHRA’s announcement, letters to inform local healthcare professionals will be issued and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Apr 17, 2019
Issued at HKT 16:00
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