Effectiveness of integrase strand transfer inhibitors among treatment-naive HIV-infected patients in China: A retrospective real-world study

Abstract

Abstract Background Integrase strand transfer inhibitors (INSTIs) in anti-retroviral therapy (ART) have been recommended by the World Health Organization for their higher efficacy, favorable safety and tolerability. However, the clinical evidence supporting switching to INSTI-containing regimes in low-and-middle-income countries is limited, as few patients have access to these regimes. We aimed to assess the effectiveness of INSTI-containing regimens in real-world settings in China compared to government-provided free ART. Method We compared the short-term and long-term effectiveness between INSTI-containing regimens and free ART drugs provided by the Chinese government in four dimensions: viral suppression status, immune response, liver and kidney function, and AIDS-related diseases. To control baseline confounders, we used propensity score matching, calculated using logistic regression including sociodemographic and baseline factors. Results Among 12,836 patients initiating ART from 2012 to 2019, 673 (5.2%) used INSTI-containing regimens. Compared with patients initiating ART with free drugs, patients initiating ART with INSTI-containing regimens were more likely to be older (43.26±14.87 vs. 36.43±12.19; p<0.001), not single (66.6% vs. 51.0%; p<0.001), infected with HIV through sexual behavior with an opposite-sex partner (50.7% vs. 42.2%; p<0.001), had a lower baseline CD4 cell count (50 cells/μL vs. 239 cells/μL; p<0.001), present more AIDS-related diseases and abnormal results of liver and kidney function, and had more TB infection. For short-term effectiveness, patients initiating INSTI-containing regimens were more likely to achieve viral suppression (81.4% vs. 52.0%; p<0.001). The differences in immune response, liver and kidney function and AIDS-related diseases were not significant between the two groups. For long-term effectiveness, viral suppression rates were similar (87.96% vs. 84.59%; p=0.135), with no significant differences in immune response, liver and kidney function, or AIDS-related diseases. Conclusions Our study suggests that patients initiating ART with INSTI-containing regimens have worse physical status at baseline than patients starting with free ART drugs. Furthermore, we found better virological performances of INSTI-containing regimens in the short-term but not in the long-term due to a high rate of drug changes. Our findings have clinical implications and provide new evidence regarding the effectiveness of INSTI-containing regimes in LMICs.