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Effectiveness and Safety of Combination of Antiretroviral therapy in HIV-1 infected patients in Western India
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| Author:
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NIRAJ SHAH, DR. I S ANAND, DR. VIPUL SHAH
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| Abstract:
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Introduction: The safety and efficacy of triple combination of antiretroviral therapy for Human Immunodeficiency Virus-1 infection in Indian population are lacking. The current study was aimed to assess the immunological efficacy and safety of combination of 2 Nucleoside Reverse Transcriptase Inhibitor and 1 Non-nucleoside Reverse Transcriptase Inhibitors in Indian population.
Materials and Methods: This was an open-label, non-randomized, multicentre study compared the immunological efficacy and safety of combination of Zidovudine/Lamivudine and Nevirapine and Tenofovir/Efavirenz/Emtricitabine. Each subject was followed up for 24 weeks. The immunological efficacy was assessed by change in CD4 cells count and CD8 cells count from baseline. Safety was assessed by recording of adverse events, laboratory data, vital signs, clinical and physical examination.
Result: A total of 200 subjects were enrolled, 100 subjects in each treatment group. The statistically significant (<0.001) increase in CD4 cells count was reported with mean increase from 222.71 cells/mm3 to 352.69 cell/mm3 and 212.39 cells/mm3 to 339.42 cell/mm3, respectively in treatment group 1 and 2. The statistically significant (<0.001) increase in CD8 cells count was reported with median increase of 294 cells/mm3 and 251 cell/mm3, respectively in group 1 and 2. The change in CD4 cells count and CD8 cells count from baseline was not statistical significant (p=0.81 and p=0.17, respectively) between the two treatment groups. There was no new safety signal reported in the study.
Conclusion: The combination of Zidovudine/Lamivudine and Nevirapine and Tenofovir/Efavirenz/Emtricitabine proves the immunological efficacy and safety and tolerability and promotes the use in the patients with HIV-1 infection of India.
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| Keyword:
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Zidovudine, Lamivudine, Nevirapine, Tenofovir, Efavirenz, Emtricitabine
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| EOI:
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| DOI:
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