Patients with HIV and a low viral load after undergoing a triple antiretroviral therapy (ART) regimen for at least 12 months who de-escalated their therapy to 4 days per week achieved non-inferior treatment success compared with patients who continued to receive a triple ART regimen daily, according to recent research from an open-label, randomized, multi-center, phase III trial.

Roland Landman, MD, from Institut de Médecine et Epidémiologie Appliquée, Hôpital Bichat, Université Paris, in Paris, France, presented the results of the ANRS 170 QUATUOR trial at the International AIDS Society (IAS) meeting in Mexico City.

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“Intermittent treatment could improve the convenience, tolerability and cost of ART,” Landman and colleagues said in their study abstract.

ANRS, the French agency for research on AIDS and viral hepatitis that conducted the trial, said in a press release that the results show daily ART “may not be indispensable.” They cited results from the ANRS 162-4D pilot trial in 2017, which showed 96% success in viral replication control in patients receiving ART for more than 1 year who lowered therapy to 4 days per week.

The results presented by Dr. Landman at IAS extended those results out to 48 weeks, with 647 patients who had a viral load below 50 copies per mL after undergoing protease inhibitor (PI), non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI) ART for at least 12 months randomly assigned to continue therapy or reduce therapy to 4 days per week. Patients were median 49 years old, 85% male and recruited between September 2017 and January 2018, and 636 patients were included in the final analysis, with 318 patients each in the intervention and control arms. 

The researchers found 95.6% of patients who received ART 4 days per week maintained viral control compared with 97.2% of patients in the group that continued receiving triple ART every day (adjusted difference, -1.6%; 95% confidence interval, -4.5%-1.3%). Patients in the 4-day ART group had moderate improvements in estimated glomerular filtration rate (5.5 [-1.2-+13.6] ml/min) compared with patients in the control group (+1.3[-6.1-+7.5] ml/min; P < .001).

With regard to virological failure, 6 patients in the 4-day ART group (1.9%) experienced failure with resistance mutation in 3 cases, while 4 patients in the control group (1.3%) experienced virological failure with 1 resistance mutation case. Landman and colleagues noted no significant difference in adverse events between groups.