Dolutegravir Plus Lamivudine Dual-Drug Regimen in Treatment-Naive HIV-1-Infected Patients With High-Level Viral Load: Preliminary Data From the Real World

Background: Some inpatients with HIV-RNA >= 500,000 copies/mL in China need to use 2-drug regimen for some reasons, although limited data are available for dolutegravir plus lamivudine (3TC) in those patients with ultra-high viral loads. Methods: We conducted a single-center retrospective-prospective study in China and enrolled 42 ART-naive HIV-infected inpatients who use a once-daily 2-drug regimen because of various reasons (drug interaction, renal impairment, age, and other related comorbidities).They were divided into 2 groups, low viral load group (baseline viral load <500,000 copies/mL, n = 20) and high viral load group (baseline viral load >= 500,000 copies/mL, n = 22). All patients were followed up for 48 weeks. Results: The median of baseline viral load was 5.74 log(10) copies/mL and CD4(+) T-cell count was 59 cells/mu L. At week 48, there was no significant difference (P = 0.598) in proportions of participants with HIV-1 RNA <50 copies/mL [90%, 95% confidence interval (CI) (75.6% to 104.4%) in low viral load groups vs 95.5%, 95% CI (86.0% to 104.9%) in high viral load groups]. No differences were found in mean increase of CD4(+) T-cell count from baseline between 2 groups (218 +/- 122 vs 265 +/- 127 cells/mu L, P = 0.245). There is no grade 3 or higher treatment-related adverse events and none discontinued treatment because of adverse events. Conclusions: The results of our study in real world support dolutegravir + 3TC dual regimen as a promising therapy option for treatment-naive HIV-infected patient with baseline viral load >= 500,000 copies/mL.

Automated summary

This study indicates that the dolutegravir plus lamivudine two-drug regimen can be a successful treatment option for HIV-infected patients with HIV-RNA >= 500,000 copies/mL in China, with no significant differences observed after 48 weeks and no severe treatment-related adverse events.