[Evaluation for two-year highly active antiretroviral therapy in Chinese HIV-1 infection patients].

Objective: To observe that antiretroviral efficacy, immune reconstitution of two-year HAART, and evaluate its side effect in Chinese HIV-1-infected patients.

Methods: Three drug regimen composed of didanosine (ddI), stavudine (d4T), and nevirapine (NVP) was used on 27 HIV-1 infected patients, Within 2 weeks before treatment, and 3, 6, 12, 18, and 24 months after the beginning of treatment peripheral blood samples were collected to measure the HIV-RNA viral load (VL) by fluorescent quantitative polymerase chain reactions (FQ-PCR), and the counts of CD3+CD4+ cells, CD3+CD8+ cells, CD4+CD45RA+CD62L+ cells, CD4+CD45RO+ cells, CD8+CD38+ cells, and CD8+CD38+/CD3+CD8+ percentage. The side effects, blood routine, main biochemical parameters, and other disadvantageous accidents were monitored during the 24-mouth treatment period. 17 males and 10 females, aged 33 +/- 11. Thirty-one sex- and age-matched healthy persons were used as controls.

Results: FQ-PCR showed that the plasma HIV-1 RNA levels 2 weeks before treatment, and 3, 6, 12, 18, and 24 months after the beginning of treatment were 5.15 logs (copies/ml), 3.37 logs, 2.24 logs, 2.02 logs, 1.97 logs, and 2.15 logs respectively. 24 months after the treatment. In 56.6% (13/24) of the patients the HIV-1 VL was < 50 copies/ml 24 months after treatment, and the counts of CD3+CD4+ cells, CD4+CD45RA+62L+ cells (nave cells), and CD4+CD45RO+ cells (memory cells) 24 months after treatment were (317 +/- 175) cells/microl, (133 +/- 65) cells/microl, and (207 +/- 85) cells/microl respectively, all significantly hoi/higher than the baseline levels [(185 +/- 73) cells/microl, (51 +/- 21) cells/microl, and (115 +/- 57) cells/microl respectively]. And the CD3+CD8+ cell count, CD8+CD38+ cell count, and CD8+CD38+/CD3+CD8+ percentage decreased from (907 +/- 435) cells/microl, (614 +/- 299) cells/microl, and 67.7% to (775 +/- 303) cells/microl, (385 +/- 131) cells/microl, and 49.7% respectively, with the lowest values in the months 3 and 6. But by the month 24, all of the parameters failed to reach the normal level. 19 of the 27 patients had side effects, such as peripheral polyneuropathy, various rashes, central nervous system disorders, abdominal pain, fullness or bloating, fever, and baldness, 21 showed abnormalities in blood routine, liver function, renal function, or lipid tests and increased gamma glutamyl transferase (GGT) and amylase. The regimen had to be changed for 3 of these patients because of paresthesia and suspected lactic acidosis.

Conclusion: The regimen with ddI, d4T and NVP foe 24 months showed a good antiretroviral effect and immune reconstitution on the HIV-1 infected persons. However, there are side effects, especially in the respect of gastrointestinal disorder and peripheral neuritis, decrease of WBC and increase of GGT and amylase.