7 Original Articles Two-year treatment outcomes of patients enrolled in India’s national first-line antiretroviral therapy programme DAMODAR BACHANI, RENU GARG, BHARAT B. REWARI, LEA HEGG, SIKHAMANI RAJASEKARAN, ALAKA DESHPANDE, K. V. EMMANUEL, POLIN CHAN, K. SUJATHA RAO ABSTRACT Background. We aimed to analyse treatment outcomes of patients receiving first-line antiretroviral therapy (ART) through the national AIDS control programme of India. Methods. Using routinely collected programme data, we analysed mortality, CD4 evolution and adherence outcomes over a 2-year period in 972 patients who received first-line ART between 1 October 2004 and 31 January 2005 at 3 government ART centres. Cox regression analysis was used to identify independent predictors of mortality. Results. Of the 972 patients (median age 35 years, 66% men), 71% received the stavudine/lamivudine/nevirapine regimen. The median CD4 count of enrolled patients was 119 cells/cmm (interquartile range [IQR] 50–200 cells/ cmm) at treatment initiation; 44% had baseline CD4 count <100 cells/cmm. Of the 927 patients for whom treatment outcomes were available, 71% were alive after 2 years of treatment. The median increase in CD4 count was 142 cells/ cmm (IQR 57–750 cells/cmm; n=616) at 6 months and 184 cells/cmm (IQR 102–299 cells/cmm; n=582) at 12 months after treatment. Over 2 years, 124 patients (13%) died; the majority of deaths (68%) occurred within the first 6 months of treatment. Those with baseline CD4 count <50 cells/cmm were significantly more likely to die (adjusted hazard ratio 2.5, 95% confidence interval 1.3–3.2) compared with patients who had baseline CD4 count >50 cells/cmm. Over the 2-year period, 323 patients (35%) missed picking up their monthly drugs at least once and 147 patients (16%) were lost to follow up. Conclusion. Survival rates of HIV-infected patients on first-line ART in India were comparable with those from other resource-limited countries. Most deaths occurred early and among patients who had advanced disease. Earlier initiation of HIV treatment and improving long term treatment adherence are key priorities for India’s ART programme. Natl Med J India 2010;23:7–12 INTRODUCTION In recent years, numerous country-level antiretroviral therapy (ART) programme initiatives have been rolled out in developing countries to rapidly increase access to treatment for those who need it. While ART programmes in resource-limited countries such as Malawi, 1 Brazil, 2 Zambia, 3 Uganda 4,5 and Haiti, 6 have shown dramatic improvements in the survival of HIV-infected patients on ART, these programmes are facing several challenges of operational and clinical management including staff shortages, 7 infrastructural deficits and inequitable access to care in rural areas, 8 ART toxicity 9 and treatment failure. 10 With an estimated 2.5 million people living with HIV (PLHIV), India has the third highest HIV burden in the world, after South Africa and Nigeria. 11 India launched its free national ART programme in April 2004 with financial support from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM). From April 2004 to December 2009, the national ART prog- ramme scaled up from 8 to 230 public sector health facilities. 12 While several studies have assessed the safety, tolerability and immunological improvements among Indian patients receiving ART in the private and non-governmental sectors, 13–19 there are no published data on survival rates of patients being treated in the free national ART programme that is being scaled up using a public health approach. With 888 000 patients cumula- tively enrolled in HIV care and 288 000 patients currently receiv- ing ART at public sector health facilities by November 2009, © The National Medical Journal of India 2010 National AIDS Control Organization, Ministry of Health and Family Welfare, Government of India, New Delhi, India DAMODAR BACHANI, K. SUJATHA RAO World Health Organization, Regional Office for South-East Asia, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi 110002, India RENU GARG, BHARAT B. REWARI, POLIN CHAN The Johns Hopkins University, Bloomberg School of Public Health, Baltimore, USA LEA HEGG General Hospital for Thoracic Medicine (GHTM) Tambaram, Chennai, Tamil Nadu, India SIKHAMANI RAJASEKARAN Sir J.J. Hospital, Mumbai, Maharashtra, India ALAKA DESHPANDE Osmania Medical College Hospital, Hyderabad, Andhra Pradesh, India K. V. EMMANUEL Correspondence to RENU GARG; gargr@searo.who.int THE NATIONAL MEDICAL JOURNAL OF INDIA VOL. 23, NO. 1, 2010