A study on individualized regimen for north Indians living with human immunodeficiency virus-1 subtype C: A public health approach

Abstract

Background: The study analyses several first line and second line drugs, CD4 counts and viral load in patients experiencing treatment failure over a period of 1 to 6 years of first line Antiretroviral Therapy (ART). The study emphasizes the implementation of tailor-made regimen and the drug resistance testing in the national programme in India. Aim and Objectives: A study on the efficacy of the first line individualized regimen of HIV-1 subtype C infected North Indian population and recommendation of first line tailor made regimen after detection of Drug Resistance Mutations (DRM) associated with first line drugs. Material and Methods: The study of HIV-1 patients taking first line ART (period 2009-2016) was conducted at ART centre, S.N Medical College, Agra, India. The follow-up of fiftyseven patients were conducted after a confirmation of genotyping test. The primary data analysis was done on the data availability based on inclusion criteria to observe the correlation between the CD4 counts and viral loads (markers of the clinical outcome) of the individual North Indian patients infected with HIV-1 Subtype C. The DRM in individual patients were analysed through the drug resistance database, Stanford University, United States of America. The study design was based on the primary data analysis of the 57 patients' drug profiles which were associated with DRM during the first line ART. The data of the resistance associated drugs, CD4 counts, viral loads of the individual patient were compiled and the patterns of drug resistance profiles were statistically analysed using Microsoft Excel 2016 and SPSS Version 22. The normality of the data was checked by Shapiro-Wilk test (p<0.05). Results: Fifty-one patients were detected with DRM. Out of 57 first line ART failure patients, 45 patients were continuing with first line and second line ART in alive condition. Twelve patients died during the treatment of first line and second line ART. Twenty four patients whose complete data of CD4 counts and viral load were available, did not show difference in drug adherence. Despite being resistant to most of the first line drugs, CD4 count increased and viral load decreased in 12 patients. Both CD4 count and viral load increased in 3 patients. Both markers declined in 2 patients while 7 of them with decrease in CD4 counts showed increase in viral loads. Median duration of treatment was 41.84 months while median treatment adherence was 98.25%. Among the 24 patients, 16 patients were shifted on second line regimen. Conclusion: The study suggests the provision of a tailor-made first line and second line individualized regimen to each patient under a policy program of National AIDS Control Organization (NACO), Govt. of India. The implementation of drug resistance testing of first- and second-line therapy is very essential for changing the suitable regimen to increase CD4 counts and decrease viral load of individual patients.

Keywords

• acquired immunodeficiency syndrome
• genotyping
• human immunodeficiency virus
• nucleoside reverse transcriptase inhibitors
• non-nucleoside reverse transcriptase inhibitor