Safety, Tolerability and Adherence of Dtg-based Regimen Among Adult Hiv Patients Attending Kenyatta National Hospital

Abstract

Background Integrase Strand Transfer Inhibitors (ISTIs) are the latest drugs to be introduced for management of Human Immunodeficiency Virus (HIV). A fixed dose combination antiretroviral therapy (ART) regimen containing Dolutegravir (DTG), a second-generation ISTI, has been rolled out as a first line treatment regimen for adult HIV patients in low- and middle-income countries. There is limited post market surveillance safety data on DTG-based ART regimens and a myriad of side effects and adverse effects have been reported. The aim of this study was to assess the safety, tolerability and adherence of DTG-based regimens among adult HIV patients at Kenyatta National Hospital. Methods The study was a descriptive cross sectional conducted at Kenyatta National Hospital. A total of 219 eligible HIV patients on DTG-based regimens were recruited and interviewed after signing informed consent forms. Data on socio-demographics, clinical, experience of adverse side effects and measures of tolerability and adherence was obtained using a pre-designed questionnaire. Data analysis was done using IBM SPSS Statistics version 21. Categorical and numerical variables were presented in frequency, distributions and measures of central tendency. To test for associations, bivariate and multivariate analysis was done using chi- square. Results A total of 219 adults HIV patients participated in the study. There were more (58%) male participants than female (42%) and their mean age was 47.6 years. Prevalence of DTG-based ART patients among adult HIV patients attending Kenyatta National Hospital Comprehensive Care Center was 24.7% (95% Confidence Interval: 10.9, 30.92; p< 0.001). The most frequent drug effects were insomnia (24.1%), headaches (19.0%) and skin hypersensitive reactions (13.9%). 87.3% of these drug effects were mild and resolved without any intervention. 2(0.9%) patients with severe skin reactions were switched from XVI DTG-based regimen. There were no deaths reported related to a DTG-based regimen adverse drug reaction. Adherence to DTG-based ART regimen was high (>80%) and 9.6% of the patients reported to be intolerant to the DTG-based regimen because of adverse drug reactions. Conclusion This study established that the DTG-based regimen was associated with mostly mild adverse drug reactions. Skin reactions were the least tolerated and resulted in DTG-based regimen switch. Generally, the DTG-based regimen had an acceptable safety profile and was tolerated by adult HIV patients attending KNH CCC.