OBJECTIVES

To study the incidence and risk factors for failure of treatment with antiretroviral therapy among adults in the national treatment program in India, and to estimate the possible number of persons living with human immunodeficiency virus (HIV) who will need a second-line treatment regimen in the next 3 and 3.5 years.

DESIGN AND SETTING

Data of a cohort of HIV-positive adult patients, who were enrolled in the government-sponsored antiretroviral therapy program, were obtained from the electronic medical record system of the largest HIV care center in India and subjected to analysis.

MAIN OUTCOMES

Treatment failure defined by the World Health Organization criteria, assessed immunologically on the basis of CD4 T cell count, with a minimum period of 12 months of follow-up and with a minimum of two CD4 T cell follow-up measures.

RESULTS

The cumulative incidence of treatment failure in the 1370 adult patients included in the study was 3.9% (95% confidence interval [CI] 2.9 to 4.9). Men had a 3.5 (1.6 to 7.4) times significantly greater risk of treatment failure. Patients who had negative changes in absolute lymphocyte count, hemoglobin concentration and body weight had 3.1 (1.6 to 6.2), 3.2 (1.6 to 6.2), and 3.5 (1.9 to 6.4) times significantly greater risk of treatment failure. In India, after 2007, by 2, 3, and 3.5 years, respectively, an estimated 16 000, 35 000, and 51 000 patients receiving antiretroviral therapy are likely to require second-line treatment.

CONCLUSION

Monitoring of hemoglobin concentration, absolute lymphocyte count, and body weight during follow-up emerged as inexpensive predictors of treatment failure in a resource-poor setting. A significant number of patients will need second-line therapy as a result of failure of their first-line antiretroviral therapy regimen in 3 and 3.5 years in India, and therefore the development of an appropriate policy for second-line drugs is urgently needed.