Real-world evaluation of the safety and tolerability of abacavir/dolutegravir/lamivudine in an incarcerated population.

Abstract

A trend of increased adverse effects and laboratory abnormalities was observed in patients treated at the University of Illinois Hospital and Health Sciences System (UIH) HIV Telemedicine Clinic after switching to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). Therefore, we sought to investigate if major clinical trials overestimated the safety and tolerability of DTG-based antiretroviral therapy (ART). This study was a single-center, retrospective, pre- and post-analysis of incarcerated patients receiving care at the UIH HIV Telemedicine Clinic, USA. Patients included were adults with HIV switched from previous ART to ABC/DTG/3TC. Primary endpoints included patient-reported adverse effects and changes in renal and hepatic function from baseline. A total of 95 patients were included in the study. After switching from previous ART to ABC/DTG/3TC, 20% of patients reported incidence of adverse effects. Most common were headache (7.4%), nausea (6.3%) rash (3.2%), fatigue (3.2%), and insomnia (2.1%). There were statistically significant increases in serum creatinine (SCr), in 20% of the patients (P < 0.0001), with a median increase of 0.38 mg/dl. ABC/DTG/3TC appears to have similar or fewer adverse effects in the real-world incarcerated population compared to clinical trials. DTG-based ART can cause statistically significant increases in SCr in some patients.