Safety and efficacy of a fixed-dose combination of zidovudine, lamivudine, and nevirapine in antiretroviral-naive and -experienced HIV-1 infected patients

Abstract number: P788

Sungkanuparph S., Kiertiburanakul S., Piyavong B., Manosuthi W., Malathum K.

Objectives: To evaluate the safety and efficacy of a fixed-dose combination (FDC) of zidovudine, lamivudine, and nevirapine (AZT/3TC/NVP) which has recently been available in developing countries and is planned to replace the extensive use of the FDC of stavudine, lamivudine, and nevirapine (d4T/3TC/NVP).

Methods: A cohort study was conducted in HIV-1 infected patients who were initiated FDC of AZT/3TC/NVP as an initial antiretroviral therapy (ART) or as switching ART from other stable regimens at a medical-school hospital in 2006. Patients were followed up for 12 months and were categorised into initial ART and switching ART groups.

Results: A total of 241 patients were included; 62% were male and mean (SD) age was 40.4 (8.7) years. Mean (SD) body weight and hemoglobin were 60.2 (11.3) kg and 13.4 (1.8) g/dl, respectively. Of 241 patients, 51 were in initial ART group and 190 were in switching ART group. In initial ART group, median (IQR) baseline CD4 cell count and plasma HIV-1 RNA were 159 (70–210) cells/mm3 and 5.4 (4.6–5.9) log copies/ml, respectively. In switching ART group, median (IQR) baseline CD4 cell count was 386 (276–519) cells/mm3 and all had plasma HIV-1 RNA <50 copies/ml. Of 190 patients, 184 (97%) switched from NNRTI-based regimens and 116 (61%) were FDC of d4T/3TC/NVP. Median (IQR) duration of ART prior to switching was 34 (22–51) months. By intend-to-treat analysis, 78% in initial ART group and 91% in switching ART group had plasma HIV-1 RNA <50 copies/ml at 12 months of FDC of AZT/3TC/NVP. At 6 and 12 months, median CD4 cell count significantly increased from baseline to 303 (p =0.030) and 352 (p < 0.001) cells/mm3 in initial ART group; 415 (p = 0.026) and 436 (p = 0.018) cells/mm3 in switching ART group. During 12-month follow-up period, 14% and 6% of patients in initial ART group and switching ART group, respectively, had discontinued FDC of AZT/3TC/NVP due to adverse events. These adverse events (initial ART, switching ART) included anaemia (4%, 3%), rashes (6%, 0.5%), nausea/vomiting (4%, 1%), hepatitis (2%, 0%), myalgia (0%, 0.5%), and non-improved lipodystrophy (0%, 0.5%).

Conclusions: A FDC of AZT/3TC/NVP has good safety and efficacy for using as initial ART in antiretroviral-naive patients and for switching ART in patients with stable ART and complete viral suppression. The virological and immunological outcomes are favourable. In resource-limited settings, a FDC of AZT/3TC/NVP is an alternative for replacing a FDC of d4T/3TC/NVP.

Session Details

Date: 19/04/2008
Time: 00:00-00:00
Session name: 18th European Congress of Clinical Microbiology and Infectious Diseases
Location: Barcelona, Spain
Presentation type:
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