A prospective study evaluating clinical outcomes and costs of three NNRTI-based HAART regimens in Kerala, India.
OBJECTIVE
This prospective, observational, study evaluates the clinical outcomes, drug utilization patterns, and adherence to treatment of patients on highly active anti retroviral therapy (HAART) at a government institution in Kerala, India.


METHODS
Patients who met criteria for treatment of HIV/AIDS were enrolled into the study, given free NNRTI-based combination therapy, and were followed for a period of 6 months. Data regarding demographics, clinical outcome, laboratory results, drug utilization, adherence and adverse effects were collected. Analysis was conducted utilizing descriptive statistics, anova, Fisher-exact, andt-test.


RESULTS
One hundred and forty-two patients with HIV-1 were enrolled in the study into three treatment groups. The mean age was 37.88 years, 64% of the patients were male, and 92% were married. Group 1 was given zidovudine, lamivudine, and nevirapine [n = 52 (37%)], group 2 was given lamivudine, stavudine, and nevirapine [n = 51 (36%)], and group 3 was given lamivudine, stavudine, and efavirenz [n = 39 (27%)]. The increase in CD4 was 107.46 (SD: 106.25). Mean medication adherence for the 104 patients who completed the study, was 90.7%; for group 1: 92.06%, group 2: 93.37%1, and group 3: 85.71% (P > 0.05). Forty (38%) patients have at least one adverse event to HARRT, with headache being the most common side effect (11.5%). Mortality rate was 3.5% during the course of the study.


CONCLUSIONS
Provision of free NNRTI-based combination therapy to patients in Kerala, India, resulted in greater than 90% adherence leading to better clinical outcomes in terms of increasing CD4 counts and low mortality, for patients consistently attending a treatment clinic.
George
C
C
Masterskill College of Nursing & Health, Kualalumpur, Malaysia.
Yesoda
A
A
Jayakumar
B
B
Lal
L
L
D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000191:economics* / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000191:economics*; D048588:Benzoxazines / Q000191:economics / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006784:Hospitals, Teaching; D006801:Humans; D007194:India; D019259:Lamivudine / Q000191:economics / Q000627:therapeutic use; D008297:Male; D055118:Medication Adherence; D019829:Nevirapine / Q000191:economics / Q000627:therapeutic use; D011446:Prospective Studies; D018119:Stavudine / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome; D015215:Zidovudine / Q000191:economics / Q000627:therapeutic use
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D018119:Stavudine; C098320:efavirenz