Trends and factors associated with modification or discontinuation of the initial antiretroviral regimen during the first year of treatment in the Turkish HIV-TR Cohort, 2011–2017

Abstract

Background There is limited evidence on the modification or stopping of antiretroviral therapy (ART) regimens, including novel antiretroviral drugs. The aim of this study was to evaluate the discontinuation of first ART before and after the availability of better tolerated and less complex regimens by comparing the frequency, reasons and associations with patient characteristics. Methods A total of 3019 ART-naive patients registered in the HIV-TR cohort who started ART between Jan 2011 and Feb 2017 were studied. Only the first modification within the first year of treatment for each patient was included in the analyses. Reasons were classified as listed in the coded form in the web-based database. Cumulative incidences were analysed using competing risk function and factors associated with discontinuation of the ART regimen were examined using Cox proportional hazards models and Fine-Gray competing risk regression models. Results The initial ART regimen was discontinued in 351 out of 3019 eligible patients (11.6%) within the first year. The main reason for discontinuation was intolerance/toxicity (45.0%), followed by treatment simplification (9.7%), patient willingness (7.4%), poor compliance (7.1%), prevention of future toxicities (6.0%), virologic failure (5.4%), and provider preference (5.4%). Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (aHR = 4.4, [95% CI 3.0–6.4]; p < 0.0001) or protease inhibitor (PI)-based regimens (aHR = 4.3, [95% CI 3.1–6.0]; p < 0.0001) relative to integrase strand transfer inhibitor (InSTI)-based regimens were significantly associated with ART discontinuation. ART initiated at a later period (2015-Feb 2017) (aHR = 0.6, [95% CI 0.4–0.9]; p < 0.0001) was less likely to be discontinued. A lower rate of treatment discontinuation for intolerance/toxicity was observed with InSTI-based regimens (2.0%) than with NNRTI- (6.6%) and PI-based regimens (7.5%) (p < 0.001). The percentage of patients who achieved HIV RNA < 200 copies/mL within 12 months of ART initiation was 91% in the ART discontinued group vs. 94% in the continued group (p > 0.05). Conclusion ART discontinuation due to intolerance/toxicity and virologic failure decreased over time. InSTI-based regimens were less likely to be discontinued than PI- and NNRTI-based ART.

Antiretroviral Therapy Regimen Modification Rates and Associated Factors in a Cohort of HIV/AIDS Patients in Asmara, Eritrea: A 16-year Retrospective Analysis

“…Many studies have reported toxicity/intolerance as a major driver of cART modi cation globally (8,11,(19)(20)(21). In Ethiopia, pooled data from 17 studies identi ed intolerance/toxicity as the major cause of treatment modi cation (8% (95% CI: 46, 69%; Range: 14.4-88.5%) (11).…”

Antiretroviral therapy regimen modification rates and associated factors in a cohort of HIV/AIDS patients in Asmara, Eritrea: a 16-year retrospective analysis

“…The recommendation was informed by high value evidence connecting d4T to lactic acidosis (LA), peripheral neuropathy, lipodystrophy, and AEs associated with mitochondrial toxicity 18 . In prior years, patients in these settings were retained on d4T (despite active www.nature.com/scientificreports/ Many studies have reported toxicity/intolerance as a major driver of cART modification globally 8,11,[19][20][21] . In Ethiopia, pooled data from 17 studies identified intolerance/toxicity as the major cause of treatment modification (8% (95% CI 46, 69%; Range: 14.4-88.5%) 11 .…”

Temporal evolution of antiretroviral therapy (2017-2021): analysis of treatment change and its economic impact

“…En este estudio retrospectivo describimos la evolución de la terapia antirretroviral en los últimos 5 años. Si analizamos estudios previos, como el de Korten et al [ 6 ] donde analizaban los motivos de cambio de TAR de 1ª línea (2011-2017), la interrupción por intolerancia/toxicidad fue la principal causa, mismo resultado que el obtenido en el estudio de SobrinoJiménez C. [ 7 ] durante diciembre del 2014. En ambos estudios el esquema ITIAN más frecuente era el que contenía tenofovir disoproxil en su forma de sal de fumarato (TDF), destacado por su toxicidad renal y ósea, y, a pesar de que estas toxicidades ya venían descritas en las guías, no fue hasta el 2018 cuando la guía geSIDA [ 8 ] menciona en sus recomendaciones de esquemas preferentes el uso únicamente de la forma tenofovir alafenamida (TAF).…”