Prospective observation for seven-year's highly active antiretroviral therapy in Chinese HIV-1 infected patients

To prospectively observe the efficacy, tolerability, immune reconstitution and toxicity of long-term highly active antiretroviral therapy (HAART) in Chinese patients infected HIV. 437 cases originally received two nucleoside reverse transcriptase inhibitors (NRTIs) and one non-nucleoside reverse transcriptase inhibitor (NNRTI) during a mean period of 4.3 years (3.1-7.3). Patients were followed up by HIV RNA levels, T lymphocyte subsets, blood routine test, and biochemical parameters. If active opportunistic infections, apparent side effects or virological failure appeared, appropriate treatment would be taken immediately. 30 patients (6.86%) died, most in the first 6 months of HAART. The proportion of subjects with HIV-1 RNA <500 copies/ml was 90.8%, 63.5%, 69.4%, 70.0% and 72.2% at 1, 4, 5, 6 and 7 year. The CD4+ T cell count was 115, 246, 301, 334, 363, 356,386 and 373 cells/ul at 0, 1, 2, 3, 4, 5, 6 and 7 year. 67.9% showed various drug-related side effects, most including gastrointestinal side-effects, nervous disorder, myelotoxicity and abnormal liver function, rashes, serum cholesterol elevation, mostly appearing in the first 12 months. Grade 3 and Grade 4 adverse events occurred in 41 cases. This is the first to report results from the prospectively 7-year follow-up of Chinese patients infected HIV taking HAART. It demonstrates that two NRTIs and one NNRTI regimens may persistently suppress HIV viremia and continuously induce CD4 cell increase, with good safety and tolerance. The majority took first-line regimens effectively. 19.2% changed to other first-line drug due to drug-related side effects, 10.2% switched to second-line regimens due to viral resistance. Some discontinued or got virological failure because of poor compliance.