Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation

Официальное название

Effectiveness and Persistence of Same-day Re-start with B/F/TAF Among Patients with HIV Who Experienced Discontinuation from Previous NNRTI Based Regimens in China

Обзор

In China, free first-line ART regimens typically consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTI). As of the end of 2022, approximately 1.135 million individuals were receiving ART, achieving a coverage rate of 92.8%, largely due to participation in free treatment programs. However, around 36,000 patients have discontinued treatment, primarily due to side effects associated with Efavirenz (EFV), a common NNRTI. The challenges posed by side effects and resistance profiles of existing NNRTIs highlight the need for effective re-initiation of ART to improve overall treatment coverage. INSTIs, particularly B/F/TAF (Bictegravir/emtricitabine/tenofovir alafenamide), demonstrates effective viral suppression and a higher barrier to resistance than NNRTIs. B/F/TAF has shown efficacy in patients with resistance mutations, making it a strong candidate for same-day ART re-initiation, especially in resource-limited areas where genotypic resistance testing may be unavailable. This study aims to evaluate the feasibility and effectiveness of rapidly restarting B/F/TAF in patients with treatment interruptions from previous NNRTI regimens.

Вмешательства

• Препарат Regimen：BIC+FTC+TAF
  Same-day restart of "BIC+FTC+TAF" among HIV patients who experienced discontinuation from previous NNRTI-based regimens

Первичные конечные точки

• The efficacy of re-initiation of B/F/TAF [Срок оценки: From enrollment to the end of treatment at 24 weeks]

Вторичные конечные точки (7)

• Drug resistance status [Срок оценки: From enrollment to the end of treatment at 48 weeks]
• The reasons for discontinuation of prior therapy [Срок оценки: From enrollment to the end of treatment at 1 week]
• The efficacy of B/F/TAF [Срок оценки: From enrollment to the end of treatment at Week 12, Week24 and Week 48]
• The persistence on B/F/TAF . [Срок оценки: From enrollment to the end of treatment at 48 weeks]
• The changes in parameters of quality of life and treatment satisfaction [Срок оценки: From enrollment to the end of treatment at Week24 and Week 48]
• The safety and tolerability on B/F/TAF [Срок оценки: From enrollment to the end of treatment at 48 weeks]
• The emergence of drug resistance [Срок оценки: From enrollment to the end of treatment at 48 weeks]

Критерии участия

Критерии включения

• Patients with 18 years old or above.
• Discontinuation of previous NNRTI based regimen for more than 90 days.
• No known CrCl< 30mL/min or severe hepatic impairment.
• No known or suspected resistance to BIC.
• No known pregnancy

Критерии исключения

••Patients who are pregnant.

• Patients who have abnormal liver and kidney function indicators(Child-pugh class C, CrCl< 30).Hepatitis virus co-infection does not serve as an exclusion criterion.
• Patients who have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC.
• Patients who are psychiatric illness or active tuberculosis co-infection.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changp — Chian

Идентификаторы

NCT: NCT06830668 · CO-US-380-7381

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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