During the study period, a total of 75 HIV-positive children were eligible for the ART, but 21 (28%) children were excluded for dropping out. The remaining 54 children who had been started on ART were included in the study. Of these 54 children, 8 (14.8%) had expired by the end of 1 year of follow up. Male children (55.6%) were more than females, which was similar to other studies.[16
] The majority (74%) of the children were above 5 years age in contrast to Agrawal et al
] and Merchant et al
In this study, the probable mode of transmission of HIV infection was from mother to children 52/54 (96.2%). Only one child was reported to have been infected through blood transfusion. Similar findings were reported by various authors[18
] in India. Tuberculosis (17%) was the only opportunistic infection reported among study children, unlike other studies on HIV in children.[18
] High prevalence of tuberculosis in HIV-infected adults leads to an increased risk of this infection in their HIV-infected children.[20
] Therefore, it is essential to monitor these children carefully and institute treatment early, since response to treatment is good. As the tuberculin test may be negative in a significant proportion of these children, chest radiographs must be obtained when tuberculosis is suspected. In contrast to the current study, other authors have reported various other opportunistic infections, such as candidiasis, herpes zoster, and pneumocystis carinii pneumonia. Almost three fourths (74%) of the parents of seropositive children had already been diagnosed positive for HIV, whereas for one quarter (26%) of the children, only the mother had been diagnosed as HIV positive. One quarter of the study children had already lost both parents, whereas both parents were still alive for 40.8% of the children.
At the beginning of ART, 29.6% children were asymptomatic (stage I), 24% had mild disease (stage II), 31.5% had moderate disease (stage III), and 14.8% had severe disease (stage IV). Reitz et al
] reported more children in stage III (51.2%) and stage IV (29.1%) at the initiation of ART in South Africa compared with present study. After 6 months of ART, stage IV cases had decreased from 14.8% to 5.5%, stage III had decreased from 31.5% to 9.3% and stage II from 24% to 13%. The number of asymptomatic cases increased from 29.6% to 63% (stage I) after 6 months of ART, and up to 70.4% after 12 months of ART. Similar findings have also been reported in South Africa[21
] after 39 weeks of ART. Significant reduction in clinical stages from severe to mild/normal clinical stage were reported by Patel et al
] and Newell et al
] in their respective studies. We report 14.8% mortality at the end of 1 year follow-up after starting ART, which is similar to the Reitz et al
] study, which reported 14% mortality after 39 weeks of ART.
The nutritional status was graded according to the classification of the Indian Academy of Pediatrics.[12
] At the beginning of ART, 15% children had normal nutrition, 25.9% children in grade 2, 27.8% children in grade 3, and 14.8% children in grade 4 protein energy malnutrition (PEM). Daga et al
] in their study at Mumbai reported more pediatric cases with grades 2, 3, and 4 PEM at the time of diagnosis of HIV. The nutritional status was normal in only 14.8% of the children at the beginning of ART, but improved to 45.7% after 12 months of ART. Similarly, the nutritional status of children in grades 2, 3, and 4 improved after 12 months of antiretroviral therapy, consequently increasing the number of children in grade 1. Many studies have reported benefits of ART with respect to both clinical and immunologic progression of disease in HIV-infected children.[24
Two groups formed for comparison of CD4% with WHO clinical stage were (1) age group 1.5–5 years and (2) age group 5–15 years. In the group of children aged 1.5–5 years, CD4% increased in WHO clinical stages I, II, and III after 6 and 12 months of ART. Similar findings were reported in a European collaborative study.[23
] After 12 months of ART in clinical stage I, CD4% significantly (P
< 0.05) increased from 15.25% to 35.36%, but in clinical stage IV in the present study, the CD4% remained the same even after 12 months of ART. In the comparison made among the group of children aged 5–15 years, CD4% increase was reported in all 4 clinical stages. The significant (P
< 0.05) CD4% increase was reported after 6 and 12 months of ART in all children, including stage 4 (severe disease). The mean CD4 count and % improved for all WHO clinical stages at 12 months of ART in the 2 age groups. Both mean CD4 count and relative percent shows a significant increase (P
< 0.01) in both age groups 1 year after initiation of antiretroviral therapy. Almost all 54 children tolerated ART very well with the exception of the 2 who developed the tuberculosis after 1 year of ART. No other side effects were reported from any child.
Frequent CD4 estimation at 3 months interval will help to track CD4 cell count more effectively, but CD4 estimation was done at 6 months intervals as per NACO guidelines. Viral load estimation was not available in the present study. A longer follow-up is required to observe adverse reactions and any treatment failure. There was no group to provide a better comparison and interpretation of results in the study. Besides, the small sample size may have negatively affected the validity of the study. A larger sample size and a group for comparison would have given the study a much stronger conclusion.