Safety and Effectiveness of Nevirapine and Dolutegravir Based Regimens in Hiv Patients at the Kenyatta National Hospital, Nairobi, Kenya

Abstract

background: the antiviral drug dolutegravir (dtg) is relatively new in the kenyan market having been launched for use in mid 2017. this integrase strand transfer inhibitor has been shown to have a faster viral suppression rate, less susceptibility to viral mutations and favourable tolerability. these properties have led to a sharp increase in its use as a drug of choice in various scenarios in the management of the human immunodeficiency virus (hiv). as a strategy for treatment optimization of hiv, there is an ongoing transition of hiv positive patients from a nevirapine (nvp) based to a dtg based regimen. however, available data on the safety and effectiveness of dtg largely came from clinical trials and from studies done in the developed countries hence the need for this study. main objective: to compare the safety and effectiveness of a dtg and a nvp based regimen in hiv patients at the kenyatta national hospital. methods: this study which used a mixture of cross-sectional and historical cohort study designs was conducted at the comprehensive care centre of kenya’s largest hospital, the kenyatta national hospital. data on patient demographics, routine viral load test results and documented adverse drug reactions (adrs) was extracted from electronic and physical patient records using a structured data collection tool. additional data on adrs was obtained from patient interviews using a pre-tested questionnaire. two laboratory tests to assess liver function and glucose levels were also carried out on each participant. the chi-square test was used to assess for any difference in viral suppression between the two groups. the influence of other variables was tested by use of multivariable logistic regression. results: a total of 111 patients met the eligibility criteria and were enrolled into the study (86 on tdf/3tc/dtg and 25 on tdf/3tc/nvp). overall, the tdf/3tc/dtg regimen had a statistically significant (p=<0.001) higher viral suppression rate (93%) than the tdf/3tc/nvp regimen (56%). there was no statistically significant difference between the two regimens in the prevalence of hepatotoxicity (p=0.549) and hyperglycaemia (p=1.0). the tdf/3tc/nvp regimen had a slightly higher prevalence of grade i headaches (8%) than tdf/3tc/dtg (7%) which was statistically significant (p=0.01). similarly, the prevalence of grade i pruritus was found to be

statistically significantly higher in the tdf/3tc/nvp arm (16%) than the tdf/3tc/dtg arm (5.8%) (p=0.008). conclusion: the tdf/3tc/dtg regimen.................................................................................................................................................................