Dolutegravir (DTG) Based Fixed Dose Combination (FDC) of Tenofovir/Lamivudine/Dolutegravir (TLD) and Viral Load Suppression in Children in Port Harcourt, Nigeria

Abstract

Background: Currently, dolutegravir (DTG) based fixed dose combinations (FDC) of tenofovir/ lamivudine/dolutegravir (TLD) and Abacavir/lamivudine/dolutegravir (ABC/3TC/DTG) is now recommended by the World Health Organisation (WHO) as the preferred first-and second line antiretroviral drug necessitating transition of eligible children to TLD.
 Objective: The objective of this study is to compare the HIV viral suppression rate at baseline and after 6 months of transition to TLD and to determine adverse drug reaction associated with the use of TLD if any.
 Methods: This was a prospective cross-sectional study carried out among stable children who were on treatment and follow up for HIV disease at the Paediatric HIV clinic of the University of Port Harcourt Teaching Hospital (UPTH). All Children who were eligible for transition to TLD, whose care givers/parents gave a verbal consent and who gave consent or accent were recruited for the study. Information obtained included the sociodemographic characteristics, weight and height, ART regimen at initiation of treatment and when it was commenced, the baseline viral load and viral load 6 months after transition and any adverse drug reaction. Obtained data were analysed. Comparison of categorical variables was done using chi square and Fischer’s exact test while A p-value of < 0.05 was set as statistically significant.
 Results: A total 106 children aged 9 to 18 years with a mean age of 13.4±2.3 years were recruited for the study. Sixty (56.6%) were males, while 59 (55.5%) were from the lower socioeconomic class. The mean weight was 44.4±11.1 kg while the mean height was 151.3 ± 15.2 cm. At baseline, 48 (45.3%) were virally suppressed (viral load < 1000 copies/ml), however after 6 months, 97 (91.5%) became virally suppressed, the difference in viral suppression rate was statistically significant (X2 =53.77, p= 0.0001). Twenty-five (23.6%) had undetectable viral load (<20 copies/ml) at baseline while 61(57.5%) had undetectable viral load after transition. All those who were virally suppressed at baseline remained so 6 months after transition. Also, 80.6% (29/36) of those with treatment failure became virally suppressed. Only one child developed severe erythematous skin rashes. There was no statistically significant relationship between viral suppression and age, sex and social class (P >0.05).
 Conclusion: This study has shown that DTG-based FDC is efficacious in the treatment of eligible children and adolescents with HIV/AIDS with significant viral load suppression in all age groups, gender and social class. Adverse drug reaction with the use of DTG-based ART is low. Transition to TLD is therefore advocated in eligible patients.