The clinical efficacy of sedoxin injection monotherapy in HIV-infected patients: A pilot study

Background: Sedoxin injection is developed from the peroral formulation of an extract of traditional Chinese medicine compound prescription that had previously shown promising antiretroviral and immune-enhancing potential in HIV -infected patients, but the effect of the intravenous form remained not determined.  Objective: To evaluate the clinical efficacy of intravenous infusion of Sedoxin injection in HIV-infected patients. Study design: an open-label, pilot study. Setting: Outpatient clinic in the Zhengcheng County Hospital, Henan, China. Patients: 28 HIV-infected adults (≥18 years, 10 male, 18 female) with HIV infection (CD4 count: 12-732 cells/µl; plasma HIV-1 RNA viral load (pVL): 7 patients<lower detection limit (LDL, 20 copies/ml), the other 11 patients 190–383810 copies/ml) who had previously received various durations of antiretroviral chemotherapy but had terminated the treatment due to severe side effects for at least a month. Intervention: Monotherapy with intravenous infusion of Sedoxin 1500 mg/day, once daily for 4 weeks. Results: After treatment, the pVL of 14 (67%) of the 21 patients whose baseline pVL>LDL decreased as compared with the baseline (-0.8±0.27 log₁₀ copies/ml, P=0.009 ), among which, 4 (19%) decreased to below the LDL (P=0.015); 17 (68%) of the 25 blood samples that were analyzed for T-cell subsets showed that an increase in the CD4⁺ cell counts from baseline (P=0.028). In addition, the disease-related symptoms of the participants also decreased as compared with the baseline, suggesting that the overall immune function of the participants improved after the treatment. No adverse effect was found. Conclusions: Sedoxin monotherapy for 4 weeks produced significant reductions in pVL level and increases in CD4⁺ cell counts, improved the overall health status and was well tolerated in HIV-infected patients. These results warrant further evaluation of the long-term clinical efficacy and tolerability of Sedoxin.
Key words: Sedoxin, HIV, AIDS, antiretroviral, CD4, Traditional Chinese medicine