Evaluation of response to protease inhibitor based first line anti-retroviral therapy (ART) regimens in human immunodeficiency virus infected children compared to standard first line non-protease inhibitor ART regimens: An Indian experience

Background: Children exposed to single dose nevirapine at birth, if tested human immunodeficiency virus (HIV) positive, cannot be given nevirapine based anti-retroviral therapy (ART). Therefore protease inhibitor (PI) based combinations are being used as first line therapy in such children. However, experience is limited regarding their efficacy and adverse effects in the Indian population. Objectives: To document clinical and immunological responses to PI based regimens as first line therapy in HIV infected children less than 5 years old compared to responses to standard nonprotease inhibitor (NPI) first line regimens recommended by National AIDS Control Organisation and World Health Organisation. Method: An observational prospective cohort study was conducted in a tertiary care hospital in Surat, India, from December 2011 to June 2013 on children less than 5 years of age with confirmed HIV status. At diagnosis, clinical staging, growth parameters and CD4 levels were assessed and the children were allotted to NPI and PI groups depending on prior nevirapine exposure. Clinical, immunological and biochemical alterations after ART initiation were assessed and compared after 6 months of therapy. Results: During the study period, there were 43 children less than 5 years of age with confirmed HIV status. Children in both NPI and PI groups showed significant improvement in clinical stage of the disease after 6 months of therapy (P<0.001). Fewer children remained in stages 3 and 4 at the end of the study in the PI group. The mean height, weight and CD4 counts of children in the PI group were significantly higher than those in NPI group after 6 months of ART therapy. Total white blood cell counts and cholesterol levels were considerably higher in the PI group (p<0.001). Conclusions: PI based regimens were effective as first line therapy in HIV infected children less than 5 years old. Both PI and NPI regimens were equally effective at 6 months of therapy but PI based regimens achieved significantly better growth parameters and CD4 levels. Elevated total cholesterol levels were observed after therapy with PI regimens.