A session was dedicated to these topics on Tuesday at the Rome 2011 IAS conference.
Andrew Pozniak showed the results of a trial comparing EFV and Lersivirine at 48 weeks.
Naive patients were randomized to 2 doses (500 or 700 mg OD) of LRV or EFV, plus Truvada. The primary end point was percentage of patients < 50 copies/ml at 48 weeks. Randomization concerned 195 patients. There were 53 remaining patients in each LRV group at W48 and 54 in the EFV group. All three arms performed equally at W48 in terms of viral load suppression, which was 79% for the LRV arms and 86% for the EFV arm. However, in South Africa, EFV performed better than LRV at baseline viral load >100,000 copies/ml, probably due to adherence issues. There were more nausea in the LRV arms. There were more grade 3-4 adverse events in the EFV arm than the LRV arms. LRV had a positive effect on LDL cholesterol.
Jan van Lunzen presented the W48 results of SPRING-1, a study designed to 3 doses of DTG (10, 29 or 50 mg) or EFV, plus Truvada (2/3) or Kivexa (1/3).
All doses of DTG produced a very rapid response in terms of viral load suppression, more rapid than EFV. At W48, no efficacy difference was found between the 4 arms. No diffrence was also found at W48 between DTG and EFV when using the RNA assay with 2 copies/ml cutoff; although patients on DTG reached more rapidly viremia < 2 copies/ml than those on EFV. No side effects were observed on DTG. DTG had a lower impact on plasma lipid levels than EFV. DTG demonstrated low pharmacokinetics variability and drug exposure increased with dose. There were no Integrase Inhibitors mutations detected through W48 in patients failing therapy.
Antony Mills presented a comparison of OD Maraviroc (MRV, 150 mg) + boosted Atazanavir (ATV) compared to Truvada plus boosted ATV.
The number of naive randomized patients was 121. The number of patients continuing the study is respectively 53 and 54. It did not allow to perform reliable statistics and it was mainly a pilotbstudy. Patients were around 350 CD4 at baseline. At the limit of 50 copies/ml, 83.6% on the second arm were undetectable compared to 74.6 in the MRV + ATV/r arm. However, this pilot study showed the potency of MRV + ATV/r, and no resistance selection was found. A new phase III study using the same design but with Darunavir/r and more than 800 patients is planned.
Scott Letendre pointed out that MRV + ATV/r should not be the best combination in terms of CSF diffusion.
Steven Reynolds spoke about the impact of HSV-2 suppression by acyclovir in HIV-infected patients in Uganda.
Acyclovir was given at 400 mg BID versus PCB in 440 HIV/HSV-2 infected patients between 300 and 400 CD4 and no antiretroviral therapy. Survival analysis was done. Seventeen patients were censored. The Kaplan Maier curve showed an overal reduction of 27% in disease progression with acyclovir, with a 38% reduction in those with higher viral loads. HIV viral load decreased significantly of -0.463 log in the acyclovir arm compared to PCB.
The last presentation of this session concerned the use of MRV OD or BID with boosted PI. It was a post-hoc analysis of MOTIVATE patients. It showed no difference between the QD MRV 150 mg dosing or the BID 150 mg MRV dosing in combination with boosted PIs ( except for TPV/r and FPV/r).
Key words: Hiv, ias, new anti retroviral drugs