Tripterygium wilfordii Hook F extract in cART-treated HIV patients with poor immune response: a pilot study to assess its immunomodulatory effects and safety

Abstract

Background:Despite combination antiretroviral therapy (cART), 20% of HIV-infected patients are unable to achieve adequate immunologic recovery, in which immune activation plays a crucial role. We hypothesize that extract of Tripterygium wilfordii Hook F (TwHF), a Chinese medication used to treat autoimmune diseases, has immunomodulatory effects that may help CD4 cell recovery.Methods:Eighteen cART-treated HIV-infected patients virally suppressed for over 12 months with suboptimal CD4 cell recovery were enrolled. TwHF extract was administered at a dosage of 10 mg three times daily for 12 months. T-cell subsets and activation markers were evaluated at baseline and during follow-up. The trial was registered at Clinicaltrials.gov (NCT02002286).Results:TwHF extract was associated with a mean increase in CD4 cell count of 88 cells/μl (95% confidential interval [CI], 72–105 cells/μl) after one year of treatment. A significant increase in the mean rate of CD4 cell recovery (26 before vs 75 cells/μl/year after TwHF use, P < 0.001) was observed. Analysis of 13 patients with activation profiles suggested that TwHF extract was associated with a decrease in T-cell immune activation which was temporally correlated with CD4 cell recovery. No discontinuation of TwHF extract was reported.Conclusion:Use of TwHF extract in HIV-infected patients was associated with a reduction in T-cell activation and improved CD4 recovery with an excellent safety profile.