Pharmacological Data of a Successful 4-days-a-week Regimen in HIV Antiretroviral Therapy (ANRS 162-4D Trial)

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Retreatment with sofosbuvir plus grazoprevir plus elbasvir plus ribavirin of patients with Hepatitis C virus Genotype 1 or 4 with RASs at failure of a sofosbuvir plus ledipasvir or plus daclatasvir or plus simeprevir regimen (ANRS HC34 REVENGE study)

International audience67th Annual Meeting of the American-Association-for-the-Study-of-Liver-Diseases (AASLD) - Boston, MA - 2016-11-1

Dual therapy combining raltegravir with etravirine maintains a high level of viral suppression over 96 weeks in long-term experienced HIV-infected individuals over 45 years on a PI-based regimen: results from the Phase II ANRS 163 ETRAL study—authors’ response

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Dual therapy combining raltegravir with etravirine maintains a high level of viral suppression over 96 weeks in long-term experienced HIV-infected individuals over 45 years on a PI-based regimen: results from the Phase II ANRS 163 ETRAL study

International audienceBackground:Dual therapy combining integrase inhibitors and NNRTIs represents a promising regimen in ageingHIV-infected individuals with long exposure to nucleoside analogues and PIs.Methods:The ANRS 163 ETRAL trial (NCT02212379) was a 96 week, multicentre, single-arm study evaluatingthe efficacy and safety of raltegravir (400 mg twice daily)/etravirine (200 mg twice daily) in individuals.45 years,on a PI-containing regimen who were integrase inhibitor and etravirine naive. The primary endpoint was the pro-portion of participants with virological success, defined by the absence of virological failure up to week 48. Mainsecondary outcomes included evolution of metabolic parameters, CD4/CD8 count, bone mineral density and in-flammatory markers. The study was designed to show an efficacy.90%, assuming a success rate95%, with apower of 80% and a 5% type-1 error.Results:One hundred and sixty-five participants (median age 52 years, duration of ART 16.9 years, viral suppres-sion 6.9 years and CD4 count 700 cells/mm3) were enrolled. By ITT analysis, viral suppression was maintained in99.4% of participants (95% CI"95.6%–99.9%) at week 48 and 98.7% (95% CI"95.0%–99.7%) at week 96. Twovirological failures occurred (week 24 and week 64) without emergence of integrase inhibitor resistance. Eightparticipants discontinued raltegravir/etravirine for adverse events, leading to a strategy success rate of 95.1%(95% CI"90.5%–97.5%) at week 48 and 92.7% (95% CI"87.5%–95.8%) at week 96. Over 96 weeks, lipid frac-tions improved (P,0.001), CD4/CD8 ratio increased, IFNc-induced protein 10 (IP-10) decreased (#8.1%), solubleCD14 decreased (#27%,P,0.001) bone mineral density improved and BMI increased.Conclusions:Raltegravir plus etravirine dual therapy demonstrated durable efficacy in virologically suppressedageing patients

Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial

International audienceBackground:Intermittent treatment could improve the convenience, tolerability and cost of ART, as well as patients' quality of life. We conducted a 48 week multicentre study of a 4-days-a-week antiretroviral regimen in adults with controlled HIV-1-RNA plasma viral load (VL).Methods:Eligible patients were adults with VL  90%, with a power of 87% and a 5% type 1 error. The study was registered with ClinicalTrials.gov (NCT02157311) and EudraCT (2014-000146-29).Results:One hundred patients (82 men), median age 47 years (IQR 40-53), were included. They had been receiving ART for a median of 5.1 (IQR 2.9-9.3) years and had a median CD4 cell count of 665 (IQR 543-829) cells/mm3. The ongoing regimen included PI/r in 29 cases and NNRTI in 71 cases. At 48 weeks, 96% of participants (95% CI 90%-98%) had no failure while remaining on the 4-days-a-week regimen. Virological failure occurred in three participants, who all resumed daily treatment and became resuppressed. One participant stopped the strategy. No severe treatment-related events occurred.Conclusions:Antiretroviral maintenance therapy 4 days a week was effective for 48 weeks in 96% of patients, leading to potential reduction of long-term toxicities, high adherence to the antiretroviral regimen and drug cost saving