Advancement of ART in China: Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese HIV/AIDS Patients

Department of Infectious Disease，Peking Union Medical College Hospital, Chinese Academy of Medical Science. Beijing 100730, China

Background: The purpose of this study was to evaluate the efficacy and safety of three nevirapine-based antiretroviral treatments(ART) for antiretroviral-naïve Chinese HIV patients.

Methods：This was a prospective, multicentre, pilot study, also as the biggest ART clinical trail in China. Of the 362 subjects screened, 198 antiretroviral-naïve subjects with CD4 lymphocyte counts between 100/ul and 350/ul were randomized to start three NVP-based antiretroviral treatments: group A, NVP+AZT+ddI; group B, NVP+3TC+d4T; group C, NVP+AZT+3TC. Viral responses, immunologic responses, adverse events and drug resistence were monitored at baseline and the end of week 4, 12, 24, 36, 52.

Results: At baseline, the plasma HIV-1 RNA was 4.44±0.68, 4.52±0.71 and 4.41±0.63 lg copies/ml in group A, B and C respectively (p=0.628). At the end of the study, suppression of plasma HIV-1 RNA to less than 50 copies/ml was achieved in more patients in group B and C than in group A (68.2%, 69% vs. 39.7%; p<0.001). There were no statistically significant differences among three groups in immunological response wthin any of the CD4 or pVL strata. 3 out of 193 patients with available genotype at baseline showed primary drug resistant. Of 26 patients with virologic failure, 17 patients showed secondary drug resistant, 16 subjects in group A and 1 subject in group B.

Conclusion: Our findings strongly support the use of 3TC+d4T and 3TC+AZT as the nucleoside analogue combination in NVP-based antiretroviral therapy. The regimen of AZT+ddI+NVP produced poor virological response,and more patients showed secondary drug resistant in this arm too.