A preliminary study on plasma concentration, short-term efficacy, and safety profile of dolutegravir in Chinese people with HIV

ABSTRACT

Background

This study examined the plasma concentration, clinical efficacy, and safety of dolutegravir (DTG) in Chinese people with HIV (PWH).

Methods

In this observational study, HIV-positive individuals on DTG-based regimens for at least 6 months were included. Plasma DTG concentrations were measured 1 month after initiating treatment. Viral loads (VL) and CD4+ T cell counts were evaluated at baseline and after 1 and 6 months of therapy. High-performance liquid chromatography was used for measuring DTG concentrations, polymerase chain reaction for VL, and flow cytometry for CD4+ T cell counts. Safety assessments included monitoring liver enzymes, serum creatinine estimated glomerular filtration rate, and adverse reactions.

Results

Eighty-two Chinese PWH were enrolled. Average VL decreased significantly from baseline by 3.1 log at 1 month and 3.5 log at 6 months. CD4+ T cell counts increased from 273 cells/mm³ at baseline to 378 cells/mm³ and 446 cells/mm³ after 1 and 6 months, respectively. Seventy-five percent achieved undetectable VLs (<20 copies/mL) by 6 months. C_max and C_τ were 4.63 and 1.98 μg/mL, respectively. The safety profile was favorable with only 4.88% experiencing transient dizziness.

Conclusion

Preliminary findings suggest higher DTG plasma concentrations in Chinese PWH compared to Western populations, with promising short-term efficacy and safety.

KEYWORDS:

• Dolutegravir
• AIDS
• plasma concentration
• efficacy
• safety
• Chinese

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

The study was approved by the ethics committee of Peking Union Medical College Hospital. Informed consent was obtained from participants prior to study enrollment.

Author contributions

T. Li and X. Du conceived the study. Sample determination and data collection were conducted by D. Li, R. Xiao, Q. Fu, X. Song, and Y. Han. Data analyses were done by D. Li, R. Xiao, and X. Du D. Li and R. Xiao wrote the first draft of the manuscript. All authors critically reviewed and revised the manuscript and approved the final version.

Acknowledgments

The authors thank the participants in the present study for their cooperation.

Additional information

Funding

This work was supported by the National Key Technologies R&D Program for the 13th Five-year Plan, Beijing, China [grant number 2017ZX10202101], Special Research Fund for the Central High-level Hospitals of Peking Union Medical College Hospital, Beijing, China [grant number 2022-PUMCH-D-008] and Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences [grant number 2021-I2M-1-037].