Shiller, Dee‐Dee;
Yao, Betty B.;
Chen, Mong‐Jen;
Orejudos, Amelia;
Mostafa, Nael M.;
Marcinak, John F.;
Burroughs, Margaret;
Boyle, Craig
Phase 1 study of safety and tolerability of an oral contraceptive containing low‐dose ethinyl oestradiol combined with glecaprevir/pibrentasvir treatment in healthy premenopausal women
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Medientyp:
E-Artikel
Titel:
Phase 1 study of safety and tolerability of an oral contraceptive containing low‐dose ethinyl oestradiol combined with glecaprevir/pibrentasvir treatment in healthy premenopausal women
Beteiligte:
Shiller, Dee‐Dee;
Yao, Betty B.;
Chen, Mong‐Jen;
Orejudos, Amelia;
Mostafa, Nael M.;
Marcinak, John F.;
Burroughs, Margaret;
Boyle, Craig
Erschienen:
Wiley, 2024
Erschienen in:
Journal of Viral Hepatitis (2024)
Sprache:
Englisch
DOI:
10.1111/jvh.13946
ISSN:
1352-0504;
1365-2893
Entstehung:
Anmerkungen:
Beschreibung:
<jats:title>Abstract</jats:title><jats:p>Glecaprevir/pibrentasvir (GLE/PIB) is an approved guideline‐recommended chronic hepatitis C virus infection treatment. GLE/PIB coadministration with ethinyl oestradiol (EE) is not recommended in current labels owing to a Phase 1 study observing Grade ≥2 alanine aminotransferase (ALT) elevation in 2 out of 12 healthy women cotreated for 11 days with GLE/PIB and oral contraceptive (OC) containing 35 μg/250 μg EE/norgestimate. No Grade ≥2 elevation was observed with low‐dose (20 μg) EE (<jats:italic>n</jats:italic> = 14). This Phase 1 study examined safety/tolerability of GLE/PIB coadministered with an OC containing low‐dose EE using a larger sample size and longer treatment duration. Healthy premenopausal women were treated with EE/levonorgestrel alone (20/100 μg, Cycles 1–2), followed by coadministration with GLE/PIB (300/120 mg; Cycles 3–4). A safety criterion of special interest was a confirmed Grade ≥2 ALT elevation (>3× upper normal limit). Adverse events (AEs) and study drugs concentrations were examined. Of 85 enrolled women, 72 initiated combined GLE/PIB + EE/levonorgestrel treatment, 66 completed the study and 19 discontinued prematurely (non‐safety reason, <jats:italic>n</jats:italic> = 16; AE [deemed unelated to GLE/PIB], <jats:italic>n</jats:italic> = 3). No participant met the safety criterion of special interest of confirmed Grade ≥2 ALT elevation. No serious/Grade ≥3 AEs were reported. Study drug concentrations were within the expected ranges. GLE/PIB in combination with an OC containing low‐dose EE was generally well tolerated with no confirmed Grade ≥2 ALT elevation and no evidence of drug‐induced liver injury. No pattern to the reported AEs and no new safety issues were identified. This was a Phase 1 study of healthy volunteers, not a registered clinical trial.</jats:p>