Switch to ATV/r + 3TC: ATLAS-M Study

The ATLAS-M Study focused on switching to ATV/r + 3TC in participants with specific criteria, aiming to assess non-inferiority compared to ATV/r + 2 NRTIs. Results at W48 indicated a higher proportion free of treatment failure with ATV/r + 3TC, with notable differences in virologic failure rates and adverse events between the two groups. Additional details on baseline characteristics, efficacy results, and adverse events were also reported.

• ATV
• ATV/r
• 3TC
• HIV
• treatment

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1. Switch to ATV/r + 3TC ATLAS-M Study

2. ATLAS-M Study: switch to ATV/r + 3TC Design Randomisation 1:1 Open-label W48 W96 > 18 years N = 133 On ATV/r + 2 NRTI 3 months HIV RNA < 50 c/mL > 6 months CD4 > 200/mm3> 6 months No previous treatment failure on or resistance to ATV and/or 3TC HBs Ag negative ATV/r 300/100 mg QD + 3TC 300 mg QD Continuation ATV/r 300/100 mg QD + 2 NRTI N = 133 Objective Primary Endpoint: proportion without treatment failure at W48 Treatment failure: virological failure (the 1st of 2 consecutive HIV RNA levels > 50 c/mL or a single level > 1 000 c/mL), any treatment modification or discontinuation, loss to follow-up, consent withdrawal, progression to AIDS, or death for any cause Non-inferiority of ATV/r + 3TC (ITT-e and per protocol analyses) ; lower limit of the 95% CI for the difference = -12%, 80% power Di Giambenedetto S. J Antimicrob Chemother 2017;72:1163-1171 ATLAS-M

3. ATLAS-M Study: switch to ATV/r + 3TC Baseline characteristics and disposition at W48 ATV/r + 3TC N = 133 ATV/r + 2 NRTI N = 133 Median age, years 44 46 Female, % 16 25 Previous AIDS event, % 13.5 12.0 Baseline CD4/mm3, median 622 616 Nadir CD4/mm3, median 274 257 Duration of HIV RNA < 50 c/mL (months), median 23.5 20.8 Duration of ART prior to study entry (years), median 2.8 2.7 HCV co-infection, % 10.5 10.5 NRTI backbone, % TDF + FTC/3TC ABC/3TC Other 79 19 2 84 14 2 Discontinued at W48, N (%) 13 (10%) 26 (20%) Virologic failure / Adverse event 2 / 4 5 / 8 Withdrew consent / Lost to follow-up 2 / 5 7 / 4 Di Giambenedetto S. J Antimicrob Chemother 2017;72:1163-1171 ATLAS-M

4. ATLAS-M Study: switch to ATV/r + 3TC Efficacy Results (W48) % free of treatment failure Treatment failure ATV/r + 3TC ATV/r + 2 NRTI p ATV/r + 3TC ATV/r + 2 NRTI Total 14 27 0.042 Virologic failure 2 6 % 100 Adverse event (treatment related) 90.1 2 5 89.5 79.8 79.7 Adverse event (not treatment related) 80 2 3 Withdrew consent 2 7 60 Loss to F-U 5 4 Other 1 2 40 Virologic failure Genotype and quantification of ATV levels in 2/2 ATV/r + 3TC and 5/6 ATV/r + 2 NRTI No mutations on RT or PRO genes Undetectable ATV levels (< 0.05 mg/L): 1/2 ATV/r + 3TC and 3/5 ATV/r + 2 NRTI 20 0 ITT-e Per protocol Switch = failure (95% CI) 10.3 (1.7 to 18.9) Switch = failure (95% CI) 9.8 (1.2 to 14.8) Di Giambenedetto S. J Antimicrob Chemother 2017;72:1163-1171 ATLAS-M

5. ATLAS-M Study: switch to ATV/r + 3TC Adverse events ATV/r + 3TC N = 133 ATV/r + 2 NRTI N = 133 Clinical adverse events of any grade, % CNS Gastrointestinal Skin and soft tissues Urinary tract Respiratory tract Infections Neoplasm Bone Other Grade 3-4 clinical adverse events (none related to treatment), N Renal colic Osteopenia/osteoporosis Emerging grade 3-4 laboratory abnormalities, % Total cholesterol LDL-cholesterol Triglycerides Total bilirubin ALT 2.3 4.5 3.0 3.8 6.0 9.0 2.3 0 9.0 3.0 6.8 0 6.0 4.5 9.8 0.8 3.0 15.0 3 4 2 0 3 4 4.8 9.0 6.3 44.4 0 0.8 4.3 1.6 28.3 0 Di Giambenedetto S. J Antimicrob Chemother 2017;72:1163-1171 ATLAS-M

6. ATLAS-M Study: switch to ATV/r + 3TC Mean change in eGFR (CKD-EPI formula) at W48, mL/min/1.73 m2 ATV/r + 3TC ATV/r + 2 NRTI p All patients + 2 - 5 < 0.001 Patients on TDF at baseline + 3 - 5 < 0.001 Lipids Significant increase in total cholesterol (p < 0.001), HDL-cholesterol (p = 0.001) and LDL-cholesterol (p = 0.047) in ATV/r + 3TC group, compared with ATV/r + 2 NRTI group Adherence Self-reported adherence not different between study arms Di Giambenedetto S. J Antimicrob Chemother 2017;72:1163-1171 ATLAS-M

7. ATLAS-M Study: switch to ATV/r + 3TC Conclusion Simplification to ATV/r + 3TC in virologically suppressed patients on ATV/r + 2 NRTI is non-inferior and superior in a post-hoc analysis as compared with the continuation of the previous triple therapy at 48 weeks A significant beneficial effect of ATV/r + 3TC in the evolution of eGFR was also observed, particularly in subjects discontinuing TDF In virologically suppressed patients on ATV/r + 2 NRTI who are not coinfected with hepatitis B virus, a switch to dual therapy with ATV/r + 3TC may be considered Di Giambenedetto S. J Antimicrob Chemother 2017;72:1163-1171 ATLAS-M