ASHM Report Back

Clinical posts from members and guests of the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) from various international medical and scientific conferences on HIV, AIDS, viral hepatitis, and sexual health.

96-week data on two dual therapy studies presented at the session on treatment strategies on Monday 24th October.

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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

  1. 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.
  2. PI/r mono therapy cannot be recommended.

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