Evaluation of the Side Effects of Antiretroviral Treatment

Abstract

Introduction: The frequency of antiretroviral therapy (ART)-induced side effects varies in HIV-infected patients. In this study, we aimed to compare drug-induced side effects developing in patients receiving different ART regimens. Materials and Methods: This study was performed after obtaining approval of İstanbul Kartal Dr. Lütfi Kırdar Training and Research Hospital"s Ethics Committee (89513307/1009/515) on 30.12.2015. Ninety-five patients with HIV infection followed-up between January 2012 and December 2015 who received ART were included in this study. Their clinical and laboratory findings were evaluated retrospectively and possible drug-related side effects were investigated. Antiretroviral therapy regimens were compared using chi-square test and Fisher"s exact test for categorical variables and with Mann-Whitney U test for numerical variables; changes in numerical variables were compared using Wilcoxon test. SPSS 22.0 software (Chicago, IL, USA) was used for data analyses. Results: All cases were treated with regimens consisting of tenofovir/emtricitabine (TDF/FTC). Three patients restarted treatment after quitting for several months, thus 98 regimens administered to 95 patients were evaluated. Forty-nine of them received protease inhibitors (PIs), 44 received integrase inhibitors (INSTIs), and five received non-nucleoside reverse transcriptase inhibitors. The median (IQR) follow-up period was seven (4-13) months. None of the patients had renal function abnormality before ART but during treatment three (3.1%) of them needed renal dose adjustment for TDF/FTC. Compared to baseline values, there were significant differences in creatinine and creatinine clearance levels during treatment (p<0.001). Hyperlipidemia developed in 50% of the patients who did not have hyperlipidemia at start of treatment and this rate differed significantly between the PI and INSTI regimens (69% and 26%, respectively, χ2 =11.214, p=0.001). Seventeen percent of the patients developed an elevation in ALT levels during the treatment, but none required treatment change for this reason. Treatment changes were made 27 times in 21 patients while 15 of these changes were due to probable side effects. Thus, of 125 treatment regimens, possible clinical side effects were observed in 30 (24%), 13 of which were diarrhea. Gastrointestinal side effects were observed in 26% with PI-based regimens and neuropsychiatric side effects were observed in 6% with INSTI-based regimens. Conclusion: The most common side effects were hyperlipidemia (50%) and diarrhea (23%). Diarrhea was responsible for two-thirds of the ART switches in our study. It is important to monitor patients receiving ART for possible side effects. The results of longer and more comprehensive follow-up are needed to obtain more definitive data.

Keywords

• HIV
• antiretroviral therapy
• tenofovir
• dolutegravir
• darunavir