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Our assessment was based on adult trial participants treated at the approved DAA dosage and treatment duration from 40 phase 3 clinical trials submitted to the FDA. Female enrollment ranged from 11% to 54% (overall mean 38%). Females with HCV genotype (GT) 1 or 3 infection had statistically significant higher unadjusted or covariant\u2010adjusted odds of achieving sustained virologic response at post\u2010treatment Week 12 (SVR12) compared with males. Odds ratios favouring females were observed among Whites and those \u226540\u2009years of age with HCV GT1 or 3 infections, and among those \u226550\u2009years of age, non\u2010cirrhotic and those with HCV GT3 infection who were treatment\u2010experienced. These differences were not clinically relevant due to the high SVR12 rate achieved by females and males, overall or in subgroups. No differences were observed in SVR12 rates between HCV GT1 mono\u2010infected and HCV GT1\/ HIV\u20101 co\u2010infected participants. Numerically, more females reported headache, fatigue and nausea compared to males, but the differences were small and predominately Grade 1 or 2 severity. Discontinuation rates for any reason or due to an adverse event were low and similar between the sexes. Our study demonstrated females successfully complete DAA regimens and achieve high SVR12 rates despite numerically higher adverse events for certain commonly reported events.<\/jats:p>","DOI":"10.1111\/jvh.13901","type":"journal-article","created":{"date-parts":[[2023,12,19]],"date-time":"2023-12-19T10:34:38Z","timestamp":1702982078000},"page":"78-87","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["<scp>Sex\u2010related<\/scp> difference analyses of efficacy and safety in clinical trials of direct\u2010acting antivirals to treat chronic <scp>HCV<\/scp> genotype 1 and 3 infections"],"prefix":"10.1111","volume":"31","author":[{"given":"Shuang","family":"Zhou","sequence":"first","affiliation":[{"name":"Center for Drug Evaluation and Research, Division of Antivirals FDA  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Qi","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, Office of Biostatistician FDA  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan J.","family":"Bersoff\u2010Matcha","sequence":"additional","affiliation":[{"name":"FDA Office of Women's Health FDA  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Poonam","family":"Mishra","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, Division of Antivirals FDA  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Struble","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, Division of Antivirals FDA  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,12,19]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(22)00386-7"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.30297"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cld.2017.03.012"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiu057"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-018-3133-6"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(96)07642-8"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.36.2335"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.32129"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000016254"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2055-6640(20)30043-1"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28901"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.45424"},{"issue":"6","key":"e_1_2_9_14_1","first-page":"590","article-title":"The effect of patient's body weight, gender and baseline viral load on the efficacy of hepatitis C therapy","volume":"52","author":"Husa P","year":"2006","journal-title":"Vnitr Lek"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1590\/S0037-86822010000300001"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.4236\/ojgas.2020.1011027"},{"key":"e_1_2_9_17_1","unstructured":"U.S. Department of Health and Human Services N.I.o.H. 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