Issn  2249-7579
e Issn  2249-7579
Publisher JOURNAL OF PHARMACEUTICAL BIOLOGY
Title

EFFECTIVENESS AND SAFETY OF ZIDOVUDINE/ LAMIVUDINE/ NEVIRAPINE IN HIV-1 INFECTED PATIENTS IN WESTERN INDIA

Authors
I S Anand
Professor, Asmara College of health sciences, Asmara, Ertirea
Vipul Shah
Physician, HIDC Clinic, Ahmedabad, Gujarat, India
Niraj Shah
Medical writing and scientific communication, SiroClinPharm, Hyderabad, Telangana, India, Research Department, Hemchandracharya North Gujarat University, Patan, Gujarat, India
Keywords
Zidovudine ,Lamivudine ,Nevirapine ,HIV-1 infection ,

Abstract

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. This was an open-label, non-randomized, multicentrestudy. The study comprised of fixed dose combination of Zidovudine 300 mg and Lamivudine 150 mg + Nevirapine 200 mg twice a day. 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. The paired t-test was used to analyze the data to measure the efficacy in terms of change from baseline to endpoint. A total of 100 subjects were enrolled. The statistically significant (<0.001) increase in CD4 and CD8 cells count was reported with mean increase from 212.39 cells/mm3 to 339.42 cell/mm3 and 758.50 cells/mm3 to 1058.40 cells/mm3, respectively. There was no new safety signal reported in the study. The combination of Zidovudine 300 mg and Lamivudine 150 mg + Nevirapine 200 mg proves the immunological efficacy and safety and tolerability and hence, promotes the use in the patients with HIV-1 infection of India

Volume / Issue / Year

6 , 1 , 2016

Starting Page No / Endling Page No

1 - 6