Antiretroviral Therapy (ART) for HIV-1 infection significantly suppresses viremia, improves CD4 count and reduces overall disease progression [1, 2]. The debate over which Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) should be prescribed in combination with Antiretroviral Therapy (ART) for the treatment of HIV infection has been growing recently[3]. The standard therapy consists of two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and one non-nucleoside reverse transcriptase inhibitor (NNRTI). Nevirapine (NVP)–based ART has shown effective antiretroviral efficacy, even in patients with advanced HIV disease, and it has been widely used in resource-limited countries [4]. The controversy over which of the two NNRTI drugs should be started in combination with NRTI for the treatment of HIV infection has been growing recently [1, 3]. Previous studies comparing NVP-based and EFV-based regimens in adult patients have shown comparable effectiveness. However, some studies have shown the superiority of EFV. There are limited data comparing NVP to EFV in HIV-infected children. A study from the United States and Uganda found an increased risk of virologic failure for patients on NVP compared to EFV based regimen [5]. However, study from Nepal showed that patient taking NVP based regimen had superior clinical outcomes than EFV based regimen [6, 7]. Compared with a regimen of didanosine, lamivudine, and EFV, a regimen of once-daily didanosine, lamivudine, and NVP was inferior and was associated with more frequent virologic failure and death [8].

In this study, wedifferences at six months assessed clinical and immunological and virological outcomes of NVP+AZT+3TC versus EFV+AZT+3TC ART regimen among HIV-1 infected children.

A cross-sectional descriptive study was conducted from May-August 2017 by reviewing ART documents of children infected with HIV-1 who were on ART at pediatric ART clinic, Asella Teaching and Referral Hospital (ATRH)

The hospital is one of the federal teaching and referral hospitals. Pediatric and child health department is one of the major departments delivering patient care service, teaching and research activities under different subunits categories. Pediatric ART clinic is one of the well-organized clinics of the hospital giving care for pediatric HIV/AIDS care and treatment.

2.1. Sample

At the time of data collection about 545 children with HIV infection were on follow up at pediatric infectious disease clinic. The sampling procedure was determined by patients’ ART regimen and to minimize sampling error and to control the effects of other NRTI patients taking AZT+3TC were included and matched under NVP+3TC+AZT versus EFV+3TC+AZT. Before and during the study period the utilization of EFV-based was low as the national guideline by then was not strongly recommending this regimen in pediatric age group. Accordingly for one patient included from EFV- based regimen two patients from NVP based regimen were included (1:2) making the sample size of (n1=61) from (EFV+3TC+AZT) and 122 from (NVP+3TC+AZT) (Fig. 1). A simple random sampling technique was used to select patient charts from each regimens using computer-generated random number.

Fig. (1). Schematic flow chart demonstrating sampling technique, ATRH, 2017.

In this study, after six months of NVP+3TC+AZT ART regimen the mean CD4 cell count increment was 215/ml, and 205/ml from EFV+AZT+3TC group the mean CD4 cell with no significant difference among the two groups which is in agreement with report from adult HIV- infection clinical trial which showed no significant differences between the groups with respect to the change in the CD4 cell count from base line [1]. Similarly, ART regimen variable was not significantly associated with recovery of CD4 counts [2, 9, 10, 11]. However; another study from Uganda reported higher mean CD4 increment among patients taking EFV based ART than their NVP-based counterparts even if NRTI back bone was not matched in this study and the study was conducted among adult patients [5].

This study also demonstrated optimal virological suppression (<1000copy/ml) in 82%(100/122) and 83%(44/61) among NVP+3TC+AZT and EFV+AZT+3TC respectively. This is incongruent with WHO recommendation which highlighted no evidence of EFV virologically superior to NVP [12]. Likewise; a cochrane review of seven randomized clinical trials demonstrated that the two drugs provided comparable levels of viral suppression in non-TB patients infected with HIV when combined with two nucleoside reverse transcriptase inhibitors [7]. How ever; in a meta-analysis patients in the EFV+AZT+3TC treatment group achieved statistically higher rates of virological response and low risk of viral failure, likely due to the effects of rifampin on NVP metabolism while a study from Nepal showed EFV based regimen had less virus suppression effects than NVP-based [6, 13, 14]. Another cohort study in Thai adult patients with advanced HIV infection showed that NVP+3TC+AZT and EFV+AZT+3TC ART regimens were equally effective in terms of virological and immunological responses [5, 15, 16, 17, 18].

Presence of chronic diarrhea during ART treatment is associated with poor CD4 cell recovery independent of the nutritional status of the patient which is in agreement with most previous studies. The reason was not clearly identified so far but could be because of associated mal-absorption and poor adherence during diarrheal episode. This research also uncovered higher baseline CD4 cell value strongly predicted good six month CD4 cell recovery and viral suppression response in both groups of patients which was supported with a large cohort study involving 861 adult patients living with HIV in Spain that showed patients with baseline CD4 count of 200 and of 201 to 350 cells/mm³ had a significantly lower chance of achieving CD4 count of 500 cells/mm³ compared with patients with baseline CD4 350 cells/mm³ and above [19].

This study also showed optimal weight recovery after initiation of ART strongly associated with better CD4 response and viral suppression which is in line with study report from South Africa which elaborated lower percentiles of weight gain after six months of ART were associated with poor subsequent treatment outcomes and a higher risk of mortality independent of other baseline characteristics. Likewise, normal weight at the start of ART was independent predictors of favorable immunological and virological outcomes in both wings which was coinciding with other observational studies where patients who were underweight had a two-fold increased risk of poor treatment outcomes [20, 21]

This research finding concluded that there is no difference in clinical, immunological and virological outcomes among patient taking NVP+AZT+3TC versus EFV+AZT+3TC regimen. The conflicting results from different studies could be explained by study design, patient selection and possible concomitant HIV-TB treatment which could significantly affect the outcomes.