Incidence and predictors of regimen-modification from first-line antiretroviral therapy in Thailand: a cohort study

Abstract

BackgroundAntiretroviral therapy markedly reduced mortality in HIV-infected individuals. However, in the previous studies, up to 50% of patients are compelled to modify their regimen in middle and low-income countries where salvage drug is still limited. This cohort study aimed to investigate the incidence and predictors of regimen modification from the first-line antiretroviral regimen in northern Thailand.MethodsAll HIV-infected patients starting antiretroviral therapy (ART) with generic drug (GPOvir®; stavudine, lamivudine and nevirapine) at a governmental hospital in northern Thailand from 2002 to 2007 were recruited. Baseline characteristics and detailed information of regimen modification until the end of 2010 were ascertained from cohort database and medical charts. As a potential genetic predictor of regimen modification, HLA B allele was determined by bead-based array hybridization (WAKFlow® HLA typing kit). We investigated predictors of the regimen modification using Cox’s proportional hazard models.ResultsOf 979 patients, 914 were eligible for the analysis. The observed events of regimen modification was 377, corresponding to an incidence 13.8/100 person-year-observation (95% CI:12.5-15.3) over 2,728 person years (PY) follow up. The main reasons for regimen modification were adverse effects (73.5%), especially lipodystrophy (63.2%) followed by rash (17.7%). Sixty three patients (17.1%) changed the regimen due to treatment failure. 2% and 19% of patients had HLA-B*35:05 and B*4001, respectively. HLA-B*35:05 was independently associated with rash-related regimen modification (aHR 7.73, 95% CI:3.16-18.9) while female gender was associated with lipodystrophy (aHR 2.11, 95% CI:1.51-2.95). Female gender (aHR 0.54, 95% CI: 0.30-0.96), elder age (aHR 0.56, 95% CI: 0.32-0.99) and having HLA-B*40:01 (aHR 0.29, 95% CI: 0.10-0.82) were protective for treatment failure related modification.ConclusionHLA-B*35:05 and female gender were strong predictors of regimen modification due to rash and lipodystrophy, respectively. Female gender, elder age, and having HLA-B*40:01 had protective effects on treatment failure-related regimen modification. This study provides further information of regimen modification for future tailored ART in Asia.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-014-0565-5) contains supplementary material, which is available to authorized users.

Rate of initial highly active anti-retroviral therapy regimen change and its predictors among adult HIV patients at University of Gondar Referral Hospital, Northwest Ethiopia: a retrospective follow up study

“…The rate of initial regimen change among adult HIV patients on HAART was found to be 10.11/100PY (95 % CI 8.29, 12.6 PY). This finding is lower than a study conducted in Thailand 13.8/100PY [ 8 ], multicenter study in North America and Europe 14.4/100PY [ 7 ], Brazil 28.3/100PY [ 10 ] and Swiss 41.5/100PY [ 9 ]. This might be explained by the difference in defining outcome variables, since in our case we did not considered treatment discontinuation as regimen change unless they restart with different regimen.…”

“…A multi-center study in North America and Europe showed that the incidence of regimen change were 14.4/100 person years (PY) [ 7 ]. Furthermore, 13.8/100PY in Thailand [ 8 ], 41.5/100PY in Swiss [ 9 ], 28.3/100PY in Brazil [ 10 ], 16.2/100PY in West Africa [ 11 ], 18.6/100PY in Kenya [ 12 ] and the proportion of regimen change in Ethiopia was 21.8 % [ 13 ]. Different studies revealed that baseline regimen [ 1 , 12 , 14 ], WHO stage [ 12 , 15 ], CD4 count [ 6 , 16 , 17 ] and patient weight [ 12 , 15 ] were some predictors of initial regimen change.…”

<p>Incidence and Predictors of Initial Antiretroviral Therapy Regimen Change Among HIV-Infected Adults Receiving Antiretroviral Therapy at Arba Minch General Hospital, Southern Ethiopia</p>

“…An assessment of the rate of initial regimen changes continuously and its predictor helps to keep patients on the first ART regimen as much as possible. 19 In this study, the incidence rate of initial ART regimen change was 11.36 (95% CI: 9.32, 13.83) per 100 personyears and the median time to initial regimen change was found to be 54 months (95% CI: 47.614, 59.819). The cumulative probability of surviving on the initial regimen at the end of the follow-up period was 52%.…”

Rate of Initial Anti-retroviral Treatment Modification and Its Predictors Among Adult Hiv/aids Patients at Pawe General Hospital, Benishangul Gumuz Region, Northwest Ethiopia

“…A rate of treatment modi cation was 41.5 per 100 person year from the Swiss HIV Cohort Study 6.3 per 100 person years in a Swaziland Cohort and 13.8/100 person-year in Northern Thailand (7,8,9). Moreover, 20% of patients in Southern India, 83% in Nigeria changed their rst ART regimen (10,11).…”