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Dual HIV therapy noninferior to triple therapy
Recent findings demonstrated that dual therapy with darunavir/ritonavir and lamivudine was noninferior to triple therapy with darunavir/ritonavir plus tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine for the maintenance of HIV-1 viral suppression.
“Darunavir-boosted with ritonavir or cobicistat is the preferred protease inhibitor in most international guidelines of HIV therapy due to its efficacy and safety profile,” Federico Pulido, MD, from the Hospital Universitario Doce de Octubre in Madrid, Spain, and colleagues wrote in Clinical Infectious Diseases. “There are no clinical trial data about the efficacy of dual therapy with boosted darunavir and lamivudine.”
Researchers examined whether dual therapy with darunavir/ritonavir and lamivudine was noninferior to triple therapy with darunavir/ritonavir plus tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine for viral suppression of HIV. They randomly assigned 257 patients on triple therapy to either continue their treatment regimen or switch to darunavir/ritonavir and lamivudine to determine how many patients without resistance had HIV-RNA less than 50 copies/mL after 48 weeks of follow-up.
Their analysis showed that 112 of 126 participants (88.9%) who received dual therapy and 114 of 123 (92.7%) participants who received triple therapy had HIV-RNA less than 50 copies/mL (difference –3.8% [95% CI, –11 to 3.4]) at week 48. Changing to dual therapy was linked to significant increases in low-density lipoprotein (LDL), high-density lipoprotein (HDL) and total cholesterol, and minor improvement in estimated creatinine clearance. However, dual therapy was not associated with a notable increase in the total/HDL-cholesterol ratio compared with triple therapy. Virological failure occurred in four patients receiving dual therapy and two patients receiving triple therapy. The proportion of patients in dual vs. triple therapy who experienced serious adverse events and those who discontinued treatment because of these events was 4.8% vs. 4.9% and 0.8% vs. 1.6%, respectively. These differences were not statistically significant.
“The results ... indicate that the combination of darunavir/ritonavir and lamivudine is as efficacious as triple therapy with darunavir/ritonavir and two nucleos(t)ides for maintenance of virological suppression in HIV-infected participants without resistance to darunavir or lamivudine,” Pulido and colleagues wrote. “This strategy has the benefit of using darunavir — a boosted protease inhibitor with a good efficacy and safety profile — and lamivudine, a nucleoside with an excellent long-term safety profile.” – by Savannah Demko
Disclosure: The researchers report that Janssen provided trial funding but did not participate in the study design, management of the trial or writing of the report. The company did receive a final draft of the manuscript for review and comments.