Abstrak
Pada tahun 2023 mulai diimplementasikan regimen Bedaquiline, Pretomanid, Linezolid dengan atau tanpa Moxifloxacin (BPaL/M) sebagai regimen pengobatan tuberkulosis resisten obat (TBC RO) dengan durasi 6–9 bulan. Meskipun memiliki durasi pengobatan yang lebih singkat, data nasional tahun 2023–2025 menunjukkan bahwa 19,4% pasien masih mengalami ketidakberhasilan pengobatan dengan cure rate sebesar 69,1%. Penelitian ini bertujuan menganalisis faktor risiko ketidakberhasilan pengobatan pada pasien TBC RO yang menggunakan regimen BPaL/M berdasarkan tingkat beban TBC di Indonesia tahun 2023–2025. Penelitian ini menggunakan desain kohort retrospektif dengan data sekunder Sistem Informasi Tuberkulosis (SITB). Sebanyak 8.746 pasien yang memenuhi kriteria inklusi dan eksklusi dianalisis menggunakan cox regression dan extended cox regression pada variabel yang tidak memenuhi asumsi proportional hazards dengan titik potong 120 hari. Hasil penelitian secara nasional menunjukkan bahwa tidak mengalami konversi sputum merupakan faktor risiko terkuat terhadap ketidakberhasilan pengobatan (aHR = 12,23; 95%CI: 10,92–13,71), diikuti oleh ketidakpatuhan pengobatan setelah 120 hari (aHR = 5,50; 95%CI: 3,82–7,91), HIV positif (aHR = 1,98; 95%CI: 1,61–2,44), HIV tidak diketahui (aHR = 1,91; 95%CI: 1,50–2,44), usia ≥45 tahun pada ≤120 hari pengobatan (aHR = 1,75; 95%CI: 1,56–1,97), riwayat pengobatan TBC sebelumnya setelah 120 hari (aHR = 1,48; 95%CI: 1,24–1,77), pola resistensi MDR (aHR = 1,17; 95%CI: 1,06–1,29), dan efek samping obat setelah 120 hari (aHR = 1,27; 95%CI: 1,04–1,54). Sebaliknya, inisiasi pengobatan >7 hari merupakan faktor protektif terhadap ketidakberhasilan pengobatan (aHR = 0,78; 95%CI: 0,71–0,86). Diperlukan penguatan pemantauan pasien berisiko tinggi, peningkatan kepatuhan pengobatan, serta pengembangan early warning system bagi pasien yang tidak mengalami konversi sputum.
In 2023, the Bedaquiline, Pretomanid, and Linezolid regimen with or without Moxifloxacin (BPaL/M) was introduced as a treatment regimen for drug-resistant tuberculosis (DR-TB), with a treatment duration of 6–9 months. Despite its shorter treatment duration, national data from 2023–2025 showed that 19.4% of patients experienced unsuccessful treatment outcomes, with a cure rate of 69.1%. This study aimed to identify the risk factors for unsuccessful treatment outcomes among patients with DR-TB receiving the BPaL/M regimen across regions with low, medium, and high TB burden in Indonesia during 2023–2025. A retrospective cohort study was conducted using secondary data from the Tuberculosis Information System (SITB). A total of 8,746 patients who met the inclusion and exclusion criteria were analyzed using Cox proportional hazards regression and extended Cox regression for variables that violated the proportional hazards assumption, with a 120-day time cut-off. Nationally, sputum non-conversion was the strongest risk factor for unsuccessful treatment outcomes (aHR = 12.23; 95% CI: 10.92–13.71), followed by treatment non-adherence after 120 days (aHR = 5.50; 95% CI: 3.82–7.91), HIV-positive status (aHR = 1.98; 95% CI: 1.61–2.44), unknown HIV status (aHR = 1.91; 95% CI: 1.50–2.44), age ≥45 years during the first 120 days of treatment (aHR = 1.75; 95% CI: 1.56–1.97), previous TB treatment after 120 days (aHR = 1.48; 95% CI: 1.24–1.77), multidrug-resistant (MDR) resistance pattern (aHR = 1.17; 95% CI: 1.06–1.29), and adverse drug events after 120 days (aHR = 1.27; 95% CI: 1.04–1.54). In contrast, treatment initiation more than 7 days after diagnosis was identified as a protective factor (aHR = 0.78; 95% CI: 0.71–0.86). These findings highlight the need to strengthen the monitoring of high-risk patients, improve treatment adherence, and implement an early warning system for patients who fail to achieve sputum conversion