- |||||||||| Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
[VIRTUAL] VIROLOGIC OUTCOMES BY RESISTANCE CATEGORY AND PRETREATMENT IN THE DUALIS STUDY ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_876; No emergence of RAMs during follow-up was observed. As shown in the DUALIS study, dual therapy with DTG+bDRV tends to be an effective treatment option with no treatment-emergent resistance for PLWH on suppressive first- or further-line ART with or without evidence of pre-existing NRTI, NNRTI or PI RAMs.
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[VIRTUAL] CLINICAL OUTCOMES OF 2-DRUG REGIMENS (2DRS) VS 3-DRUG REGIMENS (3DRS) IN HIV ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_870; After accounting for demographic and clinical characteristics, there was a similar incidence of non-AIDS events on 2DRs and 3DRs, however confounding by indication cannot be excluded. With a median follow-up of 1.7 years, 2DRs appear to be a viable treatment option with regard to clinical outcomes, although further research on long-term durability and potential toxicities of 2DRs is needed.
- |||||||||| Prezista (darunavir) / J&J, lamivudine / Generic mfg., Tivicay (dolutegravir) / ViiV Healthcare
[VIRTUAL] EMULATION OF AN RCT OF DOLUTEGRAVIR VS BOOSTED-DARUNAVIR IN ADVANCED ART NAIVE ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_507; Calendar year of starting was a key factor but results were consistent across periods of ART initiation. Under the assumptions of no unmeasured confounding and correct model specification, our analysis suggests that a RCT conducted in the target population of ART-nave patients with CD4 count<200 or AIDS is likely to show a notable reduction in risk of treatment failure in people initiated with dolutegravir vs. boosted-darunavir based therapies.
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[VIRTUAL] PLASMA & INTRACELLULAR PK AND RENAL SAFETY OF TAF 25MG WITH BOOSTED PI AND LDV/SOF ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_496; Ledipasvir/sofosbuvir (LDV/SOF) is a recommended therapy for Hepatitis C virus (HCV)...Ten participants (1 black female; 9 males [5 Hispanic, 4 white]) were enrolled; 9 were on darunavir (5 RTV, 4 COBI) and 1 on atazanavir/RTV...Unlike prior findings with TDF, adding LDV/SOF with TAF did not significantly increase plasma TFV or TFV-DP in PBMC. This is likely due to differences in hydrolysis pathways between TDF and TAF, and reassures on the safety of TAF + b/PI + LDV/SOF in HIV/HCV-coinfected patients.
- |||||||||| Prezista (darunavir) / J&J, Vemlidy (tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
[VIRTUAL] UTILITY OF MINIMALLY INVASIVE SPECIMENS TO INFORM ARV ADHERENCE TEST DEVELOPMENT ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_492; Development of POC tests to detect ARV drugs from minimally invasive specimens may be attractive to assess adherence. Our results suggest that POC assays targeting TFV, FTC or DRV in urine or FTC, EVG or DRV in whole blood may provide the most reliable indicators of ARV adherence.
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[VIRTUAL] IMMUNOLOGICAL AND CYTOKINE CHANGES IN BLOOD AND GUT MUCOSA FROM PHI BY AN EARLY ART ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_432; P3 In addition, levels of Th1 (IFN-, IL-12, MIP-1), Th2 (IL-4, IL-10) and Th17 cytokines and chemokines decreased similarly in both cases and controls at w48. An extremely early and intensified ART in PHI patients allowed good immunological reconstitution, decreased immune activation and reduced inflammatory profile in different body compartments.
- |||||||||| Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Low plasmatic concentration of intensified antiretroviral therapy in a pregnant woman: a case report. (Pubmed Central) - Jan 31, 2020 Physiological changes during pregnancy can affect pharmacokinetics and reduce a mother's bioavailability of antiretroviral drugs, potentially altering their pharmacological activity. A personalized treatment and a careful follow-up are hence mandatory for this key population.
- |||||||||| Enrollment closed, Trial primary completion date: RESIST-2: 2nd-line ART for HIV-2 Infection (clinicaltrials.gov) - Jan 22, 2020
P=N/A, N=150, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2022 --> May 2020
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Clinical, Observational data, Journal, Adverse events: Cardiovascular adverse events during treatment with darunavir-based regimens in an Italian observational study. (Pubmed Central) - Jan 21, 2020 Models that also adjusted for previous ARV exposure showed no statistically significant association between any-type CVAEs and either DRV doses, 1,200 or 800 mg/daily (as also suggested by propensity score stratification), or previous DRV exposure duration. We found no evidence of a relationship between DRV use and increased CV risk.
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Journal: Structural Adaptation of Darunavir Analogs Against Primary Mutations in HIV-1 Protease. (Pubmed Central) - Dec 21, 2019 Collective analysis of protease-inhibitor interactions in the crystal structures using principle component analysis was able to distinguish inhibitor identity and relative potency solely based on vdW contacts. Our results reveal the complexity of the interplay between inhibitor P1' moiety and S1' mutations, and validate principle component analyses as a useful tool for distinguishing resistance and inhibitor potency.
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Enrollment open: Body Composition Sub-study of the D2EFT Trial (clinicaltrials.gov) - Dec 19, 2019 P4, N=300, Recruiting, Our results reveal the complexity of the interplay between inhibitor P1' moiety and S1' mutations, and validate principle component analyses as a useful tool for distinguishing resistance and inhibitor potency. Not yet recruiting --> Recruiting
- |||||||||| Use of ibalizumab in a heavily treatment-experienced HIV-1-infected subject harbouring a multidrug-resistant virus (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_2147;
A Genotyping Susceptibility Tests (GSTs) was performed and, according to the Stanford HIVdb interpretation, identified: - on plasma RNA: susceptibility to doravirine (DOR)/etravirine (ETV)/rilpivirine (RPV), all integrase strand transfer inhibitors (INSTIs) and enfuvirtide (ENF); different degrees of resistance to DRV/r, all nucleoside reverse transcriptase inhibitors (NRTIs); a R5-tropic virus was found; - on blood DNA: susceptibility to DRV/r and emtricitabine (FTC)/abacavir (ABC); different degrees of resistance to tenofovir(TDF)/ABC, DOR/ETV, RPV, dolutegravir (DTG), ENF; a X4-tropic virus was found...Thanks to the “5% Fund” of the Italian Medicines Agency, this man received an initial loading dose of IBA (2000 mg/iv) followed by maintenance doses (800 mg/iv every 15 days) in association with a recycling regimen including FTC/RPV/tenofovir alafenamide 200/25/25 mg QD, DTG 50 mg BID, maraviroc 150 mg BID, ENF 90 mg BID (replaced with DRV/r 600/100 mg BID after 12 weeks to improve acceptability)...In this man IBA, plus an OBT with residual antiviral activity, favoured the achievement of virological control, at least in the short-term. Management of patients with no fully active drugs is an unmet clinical need and novel classes such as CD4-binding monoclonal antibodies may have a key role.
- |||||||||| Prezista (darunavir) / J&J, bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Rapid ART start in primary HIV infection: time to viral suppression in a London cohort (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_2074; Rapid start with INSTI regimens results in quicker viral suppression than with PI-based regimens in PHI, even when PIs are subsequently switched to INSTIs. Concerns about lack of a baseline VRT result prior to rapid ART start may potentially be overcome by the use of the newer INSTIs with a high genetic barrier such as dolutegravir and bictegravir.
- |||||||||| Prezista (darunavir) / J&J, emtricitabine/tenofovir disoproxil fumarate / Generic Mfg., Vitekta (elvitegravir) / Japan Tobacco, Gilead
Evaluation of the “test and treat” strategy in an high-income setting: data from a multicenter Italian cohort (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_1978; We enrolled 196 patients from 9 Italian clinical centers: 120 patients started a triple therapy with tenofovir/emtricitabine plus an integrase inhibitor (83 with dolutegravir, 21 with elvitegravir and 16 with raltegravir), 32 with abacavir/lamivudine/dolutegravir, 17 with tenofovir/emtricitabine plus boosted darunavir, 11 with tenofovir/emtricitabine plus rilpivirine. In our cohort, we did not observe an advantage in using a one-day treatment approach compared to other strategies of ARV initiation.
- |||||||||| Predictors of weight gain in patients treated with dolutegravir (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_1844;
In SCOLTA the use of TDF/FTC resulted as independent factor associated with weight gain in PLWHIV treated with DTG. Male patients with lower baseline weight and lower CD4 were those more prone to gain weight.
- |||||||||| Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
No metabolic or renal benefits when switching to an NRTI-free dolutegravir-containing 2 drug regimen (2DR) - a subanalysis of the DUALIS study (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_1697; Purpose: The DUALIS study assessed efficacy and safety of switching to Dolutegravir (DTG) and boosted darunavir (bDRV) (2DR) and has demonstrated non-inferiority as compared to 2 NRTI+bDRV (3DR). While being non-inferior with regard to virologic suppression, a switch to a 2DR consisting of DTG+bDRV does not yield significant metabolic or renal advantages by substituting the NRTI components of a comparative 3DR antiretroviral therapy.
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