An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1
Abstract. Background:. Single-tablet regimen (STR) provides a convenient once-daily regimen for the prevention of human immunodeficiency virus (HIV) infection. Here, we investigated the safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as a three-d...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer
2022-11-01
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| Series: | Chinese Medical Journal |
| Online Access: | http://journals.lww.com/10.1097/CM9.0000000000002494 |
| _version_ | 1797840243040190464 |
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| author | An Liu Ruolei Xin Hongwei Zhang Lili Dai Ruojun (Esther) Wu Xi Wang Aixin Li Wei Hua Jianwei Li Ying Shao Yue Gao Zhangli Wang Jiangzhu Ye Gulimila A bu dou re xi ti Zaicun Li Lijun Sun Yanjie Yin |
| author_facet | An Liu Ruolei Xin Hongwei Zhang Lili Dai Ruojun (Esther) Wu Xi Wang Aixin Li Wei Hua Jianwei Li Ying Shao Yue Gao Zhangli Wang Jiangzhu Ye Gulimila A bu dou re xi ti Zaicun Li Lijun Sun Yanjie Yin |
| author_sort | An Liu |
| collection | DOAJ |
| description | Abstract. Background:. Single-tablet regimen (STR) provides a convenient once-daily regimen for the prevention of human immunodeficiency virus (HIV) infection. Here, we investigated the safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as a three-drug, STR for post-exposure prophylaxis (PEP) in Chinese individuals.
Methods:. This was a prospective, open-label, single-arm trial conducted in a sexually transmitted diseases and acquired immunodeficiency syndrome clinic of a tertiary hospital in Beijing, China. Adults requiring PEP were prescribed BIC/FTC/TAF one pill once a day for 28 days. Clinical and laboratory data were collected and analyzed at baseline, weeks 2, 4, 8, 12, and 24.
Results:. Of 112 participants enrolled in the study, 109 (97.3%) were male and the mean age was 30 ± 8 years. PEP completion was 96.4% (95% confidence interval: 91.1–99.0%). Two participants stopped PEP after 2 days because the source partner was identified as HIV uninfected. One participant was excluded due to hepatitis B virus infection according to the exclusion criteria. One discontinued due to the participant's decision. No participant acquired HIV through week 24. Adherence was 98.9% (standard deviation [SD]: 3.3%) by self-reporting and 98.5% (SD: 3.5%) by pill count. Only five participants experienced mild clinical adverse events attributed to the study drug (including headache, diarrhea, and nausea) and four participants had elevated serum creatinine (grade 1).
Conclusions:. A once daily, STR of BIC/FTC/TAF used as PEP was safe and well-tolerated with a high rate of completion and adherence in Chinese. BIC/FTC/TAF may be a good option for PEP.
Trial Registration:. ChiCTR.org.cn, ChiCTR2100048080 |
| first_indexed | 2024-04-09T16:11:44Z |
| format | Article |
| id | doaj.art-e8d517ecdd514fcd84732b5525aaef1f |
| institution | Directory Open Access Journal |
| issn | 0366-6999 2542-5641 |
| language | English |
| last_indexed | 2024-04-09T16:11:44Z |
| publishDate | 2022-11-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | Chinese Medical Journal |
| spelling | doaj.art-e8d517ecdd514fcd84732b5525aaef1f2023-04-24T10:04:04ZengWolters KluwerChinese Medical Journal0366-69992542-56412022-11-01135222725272910.1097/CM9.0000000000002494202211200-00011An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1An LiuRuolei XinHongwei ZhangLili DaiRuojun (Esther) WuXi WangAixin LiWei HuaJianwei LiYing ShaoYue GaoZhangli WangJiangzhu YeGulimila A bu dou re xi tiZaicun LiLijun SunYanjie YinAbstract. Background:. Single-tablet regimen (STR) provides a convenient once-daily regimen for the prevention of human immunodeficiency virus (HIV) infection. Here, we investigated the safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as a three-drug, STR for post-exposure prophylaxis (PEP) in Chinese individuals. Methods:. This was a prospective, open-label, single-arm trial conducted in a sexually transmitted diseases and acquired immunodeficiency syndrome clinic of a tertiary hospital in Beijing, China. Adults requiring PEP were prescribed BIC/FTC/TAF one pill once a day for 28 days. Clinical and laboratory data were collected and analyzed at baseline, weeks 2, 4, 8, 12, and 24. Results:. Of 112 participants enrolled in the study, 109 (97.3%) were male and the mean age was 30 ± 8 years. PEP completion was 96.4% (95% confidence interval: 91.1–99.0%). Two participants stopped PEP after 2 days because the source partner was identified as HIV uninfected. One participant was excluded due to hepatitis B virus infection according to the exclusion criteria. One discontinued due to the participant's decision. No participant acquired HIV through week 24. Adherence was 98.9% (standard deviation [SD]: 3.3%) by self-reporting and 98.5% (SD: 3.5%) by pill count. Only five participants experienced mild clinical adverse events attributed to the study drug (including headache, diarrhea, and nausea) and four participants had elevated serum creatinine (grade 1). Conclusions:. A once daily, STR of BIC/FTC/TAF used as PEP was safe and well-tolerated with a high rate of completion and adherence in Chinese. BIC/FTC/TAF may be a good option for PEP. Trial Registration:. ChiCTR.org.cn, ChiCTR2100048080http://journals.lww.com/10.1097/CM9.0000000000002494 |
| spellingShingle | An Liu Ruolei Xin Hongwei Zhang Lili Dai Ruojun (Esther) Wu Xi Wang Aixin Li Wei Hua Jianwei Li Ying Shao Yue Gao Zhangli Wang Jiangzhu Ye Gulimila A bu dou re xi ti Zaicun Li Lijun Sun Yanjie Yin An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1 Chinese Medical Journal |
| title | An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1 |
| title_full | An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1 |
| title_fullStr | An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1 |
| title_full_unstemmed | An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1 |
| title_short | An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1 |
| title_sort | open label evaluation of safety and tolerability of coformulated bictegravir emtricitabine tenofovir alafenamide for post exposure prophylaxis following potential exposure to human immunodeficiency virus 1 |
| url | http://journals.lww.com/10.1097/CM9.0000000000002494 |
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