The Immunomodulatory Effects of Artesunate on Immunological Non-responders in Long-term ART-treated People Living with HIV in Selected Provinces in China: A Non-randomized Concurrent Control Trial

To investigate the immunomodulatory effects of artesunate in the immunologic non-responders (INRs) in people living with HIV (PLWH), and suggest new adjuvant strategies for HIV treatment in INRs. A total of 197 INRs receiving antiretroviral therapy (ART) for at least 24 months from eight medical centers in China were enrolled. Artesunate tablets at different dosages were administered based on the conventional antiviral treatment regimen for 48 weeks. We evaluated immunological parameters at the baseline and during the follow-up period. There were significant increases in CD4+ T cell counts and CD45RA+ T cell counts in the ART + high-dose artesunate group after 24 and 48 weeks of treatment (P < 0.05). The recovery level of CD8+CD38+ T cell counts after 24 and 48 weeks was significantly lower in ART + low-dose artesunate group than ART + high-dose artesunate group (Padj = 0.007 and P = 0.002, respectively). The level of CD4+Ki67+/CD4+, early apoptosis cell counts/CD4+ and early apoptosis cell counts/CD8+ in ART + high-dose artesunate group were significantly recovered during duration (P < 0.05). There were no significant differences in the level of CD4+CD25+T cell counts and CD4+CD38+T cell counts among the three groups after 24 and 48 weeks of treatment (P > 0.05). High-dose artesunate could benefit INRs in terms of CD4+ T cell counts by enhancing the functional recovery of the thymus and decreasing the level of immune activation and apoptosis. This study was registered at the Chinese Clinical Trial Registry with DOL number as CHiCTR1800015289.