ViiV Healthcare, Durham, North Carolina, USA.
ViiV Healthcare, Collegeville, Pennsylvania, USA.
J Int AIDS Soc. 2022 Sep;25(9):e26006. doi: 10.1002/jia2.26006.
The CUSTOMIZE hybrid III implementation-effectiveness study evaluated implementation of once-monthly long-acting (LA) cabotegravir + rilpivirine in diverse US healthcare settings. Here, we report patient participant perspectives after 12 months in CUSTOMIZE.
CUSTOMIZE was a phase IIIb, 12-month study conducted from July 2019 to October 2020 at eight diverse US HIV clinics that enrolled virologically suppressed people living with HIV-1 (PLHIV) on a stable oral regimen to receive monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. Participants were administered quantitative surveys before injections at months 1 (baseline), 4 and 12. A randomly selected subset of participants was interviewed at baseline and month 12. Data collection at month 12 was completed by October 2020 (during the COVID-19 pandemic).
At baseline, 109 and 34 participants completed surveys and interviews, respectively; 87% were male; 35% were Black or African American. All participants who remained in the study at month 12 (n = 102) maintained HIV-1 RNA <50 copies/ml; two participants withdrew due to injection-related reasons. Mean total scores measuring acceptability and appropriateness of cabotegravir + rilpivirine LA were high at baseline (4.5-4.6 out of 5) and month 12 (4.7-4.9). At month 12, 74% of participants reported nothing interfered with receiving LA injections; injection pain or soreness was the most common concern (15%). Time spent in the clinic and coming to the clinic for monthly injections was very or extremely acceptable after 12 months for most participants (93% and 87%, respectively), with 64% reporting having spent ≤30 minutes in the clinic for injection visits. At month 12, 92% of participants preferred LA injections to daily oral tablets (3%); 97% plan to continue LA treatment going forward. In month 12 interviews, 24 (77%) of 31 participants reported the COVID-19 pandemic did not impact their ability to receive treatment.
Once-monthly cabotegravir + rilpivirine LA was highly acceptable among PLHIV who were virologically suppressed on a stable antiretroviral regimen and interested in trying LA therapy, with few participants reporting challenges receiving LA injections. Implementation data from CUSTOMIZE suggest that monthly LA injections provide a convenient and appealing treatment option for PLHIV.
CUSTOMIZE 混合 III 实施效果研究评估了在不同美国医疗保健环境中每月一次长效（LA）卡替拉韦和利匹韦林的实施情况。在此，我们报告了 CUSTOMIZE 中 12 个月后的患者参与者的观点。
CUSTOMIZE 是一项为期 12 个月的 IIIb 期研究，于 2019 年 7 月至 2020 年 10 月在八家不同的美国 HIV 诊所进行，该研究招募了病毒学抑制的 HIV-1 感染者（PLHIV），他们正在服用稳定的口服药物治疗方案，在接受为期 1 个月的口服导入期后，每月接受一次卡替拉韦和利匹韦林 LA 注射。参与者在注射前的第 1 个月（基线）、第 4 个月和第 12 个月接受定量调查。在基线和第 12 个月随机选择了一部分参与者进行访谈。第 12 个月的数据收集于 2020 年 10 月完成（在 COVID-19 大流行期间）。
在基线时，109 名参与者完成了调查，34 名参与者完成了访谈；87%为男性；35%为黑种人或非裔美国人。所有在第 12 个月仍在研究中的参与者（n=102）均保持 HIV-1 RNA<50 拷贝/ml；两名参与者因注射相关原因退出。基线时，测量可接受性和适宜性的卡替拉韦+利匹韦林 LA 的总得分均较高（5 分制中得分为 4.5-4.6），第 12 个月时得分为 4.7-4.9。在第 12 个月时，74%的参与者报告没有任何事情干扰他们接受 LA 注射；注射疼痛或酸痛是最常见的问题（15%）。大多数参与者在第 12 个月时非常或极其接受在诊所花费的时间和每月到诊所接受注射（分别为 93%和 87%），64%的参与者报告在注射就诊时在诊所花费的时间≤30 分钟。在第 12 个月时，92%的参与者更喜欢 LA 注射而不是每日口服片剂（3%）；97%的参与者计划继续进行 LA 治疗。在第 12 个月的访谈中，31 名参与者中的 24 名（77%）报告 COVID-19 大流行并未影响他们接受治疗的能力。
对于病毒学抑制的、正在服用稳定抗逆转录病毒药物治疗方案且有兴趣尝试 LA 治疗的 PLHIV 来说，每月一次的卡替拉韦+利匹韦林 LA 非常容易接受，很少有参与者报告在接受 LA 注射方面存在挑战。来自 CUSTOMIZE 的实施数据表明，每月一次的 LA 注射为 PLHIV 提供了一种方便且有吸引力的治疗选择。
