Evaluation of Human Immunodeficiency Virus Type 1-Infected Chinese Patients Treated with Highly Active Antiretroviral Therapy for Two Years

Abstract

The purpose of this study was to evaluate the long-term efficacy and safety of nevirapine in combination with didanosine and stavudine in the treatment of human immunodeficiency virus (HIV)1-infected Chinese patients in routine clinical practice. The study, from April 2003 to May 2005, with follow-up through 24 mo, was conducted at the Department of Infectious Diseases, Second Xiangya Hospital, Central-South University in Changsha, Hunan Province, China. Twenty-seven HIV1-infected patients received didanosine, stavudine, and nevirapine. Information from case notes regarding age, sex, side effects, viral load, naive and memory T cells, and CD4(+) and CD8(+) T cell count at baseline, 3, 6, 12, 18, and 24 mo was collected and analyzed. Virologic suppression, defined as an HIV RNA concentration of less than 50 copies/mL at months 3, 6, 12, 18, and 24, was considered the main outcome measure. Of 27 patients, 17 were men with a mean age 33.5 yr. The mean baseline viral load was 5.15 log copies/mL and the mean CD4(+) cell count was 185 cells/dL. Of 27 patients, 3 patients discontinued study medication; treatment was changed, because of side effects, from didanosine (ddI), stavudine (d4T), and nevirapine (NVP) to zidovudine, lamivudine, and NVP for 24 patients who had completed 24 mo of treatment with ddI, d4T, and NVP; and viral load suppression was attained in 17 patients (70.8%) at 12 mo, in 14 patients (58.3%) at 18 mo, and in 13 patients (56.6%) at 24 mo. The CD4 T cell count increased by 114 cells/microL (mean, 299 cells/microL) after 12 mo of treatment and by 132 cells/microL (mean, 317 cells/microL) after 24 mo of treatment. Naive T cells and memory cells also increased in number, but at a slower rate. Activated (CD38(+)) CD8(+) T cells were elevated at baseline (67.7%) and declined by month 24 (49.7%), but did not reach normal levels. We conclude that a regimen of NVP with ddI and d4T provided durable suppression of plasma viral load in HIV-infected patients, with significant improvement in the CD4 cell count, and can be well tolerated by patients with HIV-1 infection.