96-week data from ATLAS – M trial – a multicenter, open labeled, randomized trial on simplification to atazanavir/ritonavir and lamivudine versus maintaining atazanavir/ritonavir with 2 NRTI (Triple therapy) in virologically suppressed HIV infected patients was presented by Roberta Gagliardini, Catholic University from Rome, Italy.
- A total of 266 patients (78%males with a median CD4 of 603 cells, 79% of them had Tenofovir in their treatment regimen) were enrolled in this trial.
- 96 week data were available for 254 (126 in dual therapy arm and 128 in triple therapy arm).
At 96 weeks, the proportion of patients free of treatment failure were 77.8% (95% CI 70.5 – 85.1) in the dual therapy arm compared to 65.6% (95% CI 57.4 – 78.3) in the triple therapy arm.
Virological failure was observed in two patients (1.6%) randomized to dual therapy arm and eight (6.3%) patients in the triple therapy arm (p=0.056).
- Data demonstrated non-inferiority of treatment simplification to dual therapy in virologically suppressed patients.
- Additionally, switch was associated with improved renal function but with increased total cholesterol and bilirubin levels in dual therapy arm.
ANRS 12286/MOBIDIP trial investigator Laura Ciaffi from France presented 96-week data to show that dual therapy with a boosted protease inhibitor plus lamivudine is an effective maintenance strategy in patients on second-line antiretroviral therapy in Africa.
- This randomised, open-label, clinical trial was conducted in Cameroon, Senegal and Burkina Faso.
- Recruited HIV-1 positive patients on stable protease inhibitors plus NRTIs as second-line Antiretroviral therapy.
- All patients had HIV viral load below 200 copies/mL, CD4 above 100 cells/mm3 and adherence was ≥90%.
- Two arms of the trial compared monotherapy with the ongoing protease inhibitor/ritonavir(PI/r): darunavir (DRV/r) or lopinavir (LPV/r) with the same PI/r associated with lamivudine 300 mg in the dual therapy arm.
- From March 2014 to January 2015, 265 patients were randomised (133 in mono-therapy arm and 132 in dual therapy arm).
- Most patients were women (73%).
- At failure of first line, 96% had the M184V mutation.
At 48 weeks, Data Safety Board instructed to stop mono therapy arm.
In the ITT analysis, 3.0% (95% CI 0.8–7.6) in the dual therapy arm and 22.6% (95% CI 15.8–30.6) in the mono- therapy arm had virological failure (p<0.001).
- Median time to failure was 24 weeks.
- All failing patients, except one, re-suppressed to less than 200 copies/mL in a median time of 12 weeks after reintroduction of the NRTI backbone.
- Increase in CD4 was significantly higher in the dual therapy arm (48 vs 7 cells/mm3).
- No differences in adverse events were observed.
Investigators concluded that
- after viral suppression with PI/r plus NRTIs in second-line therapy, maintenance with PI/r plus lamivudine is associated with a high rate of success despite the presence of M184V.
- PI/r mono therapy cannot be recommended.