- |||||||||| Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / ViiV Healthcare
[VIRTUAL] Dolutegravir and Doravirine in Combination: When Standard Antiretroviral Regimens are Unacceptable () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1223; Doravirine is attractive for this population as it can be used in renal impairment, moderate hepatic impairment, is unaffected by timing of meals, and (unlike rilpivirine) has no interaction with proton pump inhibitors. Dolutegravir is included in NRTI-sparing regimens that HHS guidelines suggest should be considered in older PWH, especially with CKD.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
[VIRTUAL] Contraception, Pregnancy and ART in Women of Child-Bearing Years () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1128; Dolutegravir is very commonly used due to its tolerability and simplicity. While recent reports show the risk of NTD to be lower than previously thought, it is still elevated compared to other ART and a more open discussion of pregnancy plans, contraception, and NTD if applicable, needs to occur in women living with HIV.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal, Real-World Evidence: Bone Safety of Dolutegravir-Containing Regimens in People Living with HIV: Results from a Real-World Cohort. (Pubmed Central) - Aug 9, 2020 As regards LS BMD, patients with osteopenia/osteoporosis at study entry experienced a high increase from baseline (20.6, 95% CI: 3.1, 38.1 mg/cm), as well as experienced subjects (16.9, 95% CI: 4.7, 29.2 mg/cm) and those on vitamin D supplementation (26.8, 95% CI: 7.7, 45.9 mg/cm). Dolutegravir-containing regimens could reduce the negative impact of antiretroviral therapy on bone, especially in patients with low BMD.
- |||||||||| Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal, Real-World Evidence: Real-World Experience with Dolutegravir-Based Two-Drug Regimens. (Pubmed Central) - Jul 30, 2020 Prior to commercial availability of the single-tablet 2DRs, DTG 2DR components were primarily used in treatment-experienced patients for treatment simplification and avoidance of long-term toxicities. Many of these patients achieved and maintained virologic suppression, with low discontinuation rates.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial initiation date: DoRIS: Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin (clinicaltrials.gov) - Jul 26, 2020 P4, N=36, Not yet recruiting, Ultrafiltration results greatly depended on analytical conditions, confirming the need to validate the method by comparison with ED in order to correctly interpret DTG Cu. Initiation date: Apr 2020 --> Nov 2020
- |||||||||| bictegravir (GS-9883) / Gilead
[VIRTUAL] Integrase-based first-line HIV antiretroviral treatment in the Mediterranean Resistance (MeditRes) HIV collaboration () - Jul 26, 2020 - Abstract #HIVGlasgow2020HIV-Glasgow_61; Here we describe the most recent data on transmitted drug resistance to integrase‐based first‐line regimens in Mediterranean Europe. Given the low prevalence of clinically relevant resistance to second‐generation INSTIs and to first‐line NRTIs, in the years 2018 and 2019 it is very unlikely that a newly diagnosed patient in MeditRes countries would present with baseline resistance to a first‐line regimen based on second‐generation INSTIs.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
[VIRTUAL] What is new in HIV paediatrics? () - Jul 26, 2020 - Abstract #HIVGlasgow2020HIV-Glasgow_12; This year sees the approval of a 5 mg dolutegravir tablet (dispersible) for use down to four weeks of age (3 kgs), but only seven years after approval for adults...Currently, children aged <6 years (<25 kgs) do not have access to fixed dose combinations, but pharmacokinetic modelling suggests that the FDC “Biktarvy” may be considered down to two years of age...Worldwide, there are now over 15 million HIV exposed uninfected children (HEUs), recent studies show that they have an increased risk of infections, developmental delays, stunting, and other issues. The future for HEUs should be not just HIV free, but also with every opportunity to thrive, studies are underway to better understand influences on their outcomes.
- |||||||||| Edurant (rilpivirine) / J&J, Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: Effect on HIV Medications on EPC Cells (clinicaltrials.gov) - Jul 23, 2020 P=N/A, N=30, Recruiting, In treatment-naïve and treatment-experienced women living with HIV, women taking DTG had the lowest risk for early (≤1 year) discontinuation. Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Jun 2020 --> Oct 2020
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Switch to dolutegravir and unboosted atazanavir in HIV-1 infected patients with undetectable viral load and long exposure to antiretroviral therapy. (Pubmed Central) - Jul 22, 2020 Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Jun 2020 --> Oct 2020 : We evaluated efficacy and safety of a two-drug regimen including dolutegravir (DTG) and unboosted atazanavir (uATV) in 151 HIV-1 infected patients with HIV-RNA > 50 copies/ml.During a median follow-up of 62 (42-97) weeks, 2 VFs (1%) and 13 treatment discontinuations (9%) occurred; the 48-week probability of VF was 0.8% (95% CI = 0.2%-5.6%).Switch to DTG + uATV may represent a boosting and RTIs sparing option in subjects with long exposure to ART and risk of cardiovascular disease.
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, lamivudine / Generic mfg., Tivicay (dolutegravir) / ViiV Healthcare
Biomarker, Clinical, Journal: Safety and tolerability of Triumeq in amyotrophic lateral sclerosis: the Lighthouse trial. (Pubmed Central) - Jul 22, 2020 P2a Funding: Funding was provided by the FightMND Foundation; MND Research Institute of Australia; MND Association, United Kingdom, and GSK. ViiV Healthcare provided the Triumeq.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals (clinicaltrials.gov) - Jul 20, 2020 P2, N=72, Not yet recruiting, This project illustrates how enhancements to the national HMIS can facilitate the use of routine patient-level data to monitor the transition to new ARVs and inform the national HIV response. Trial completion date: Feb 2021 --> Nov 2021 | Trial primary completion date: Feb 2021 --> Sep 2021
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare, abacavir/lamivudine / Generic mfg., Vemlidy (tenofovir alafenamide) / Gilead
Clinical, Journal: No impact of previous NRTIs resistance in HIV positive patients switched to DTG+2NRTIs under virological control: Time of viral suppression makes the difference. (Pubmed Central) - Jul 18, 2020 All HIV-1 positive drug-experienced patients who started a regimen composed by DTG+2NRTIs [abacavir/lamivudine or tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF)/emtricitabine (FTC)] in the ARCA collaborative group with HIV-RNA <50 cp/mL were included in the analysis...Conversely, the duration of viral suppression before switch resulted associated with a lower risk of VF (for 1 month increase, adjusted 0.98, 95%CI 0.96-0.99; p=0.024). Previous NRTIs mutations appeared to have no impact on the risk of VF in patients switched to DTG+2NRTIs, whereas a longer interval on a controlled viremia decreased significantly the risk of VF.
- |||||||||| Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Journal: Trends in HIV-1 Drug Resistance Mutations from a U.S. Reference Laboratory from 2006 to 2017. (Pubmed Central) - Jul 9, 2020 Sequences with ≥1 darunavir DRM declined from 18.1% to 4.8% by 2017...Prevalence of elvitegravir-associated DRMs T66A/I/K, E92Q, S147G, and the dolutegravir-associated DRM R263K increased...These trends may inform the need for baseline genotypic resistance testing. The detection of treatment-emergent DRMs in serially-tested patients confirms the value of genotypic testing following virologic failure.
- |||||||||| Prezista (darunavir) / J&J, ritonavir / Generic mfg., Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Efficacy and safety of dolutegravir plus boosted-darunavir dual therapy among highly treatment-experienced patients. (Pubmed Central) - Jul 9, 2020 P=N/A The detection of treatment-emergent DRMs in serially-tested patients confirms the value of genotypic testing following virologic failure. In highly treatment-experienced who were virologically suppressed, switching to the combination of dolutegravir plus boosted-darunavir dual therapy was effective and well tolerated, improving lipid and renal parameters.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Journal: Quantum-Chemistry Based Design of Halobenzene Derivatives With Augmented Affinities for the HIV-1 Viral G/C Base-Pair. (Pubmed Central) - Jul 9, 2020 This should enable the improvement in a modular piece-wise fashion, the affinities of halogenated inhibitors for viral DNA (vDNA). In view of large scale polarizable molecular dynamics simulations on the entirety of the IN-vDNA-inhibitor complexes, validations of the SIBFA polarizable method are also reported, in which the evolution of each ΔE(SIBFA) contribution is compared to its QC counterpart along this series of derivatives.
- |||||||||| Descovy (emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Enrollment open, Adherence: APTAMER: Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs (clinicaltrials.gov) - Jul 8, 2020 P1, N=30, Recruiting, In view of large scale polarizable molecular dynamics simulations on the entirety of the IN-vDNA-inhibitor complexes, validations of the SIBFA polarizable method are also reported, in which the evolution of each ΔE(SIBFA) contribution is compared to its QC counterpart along this series of derivatives. Not yet recruiting --> Recruiting
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
[VIRTUAL] When First-Line Fails: Salvage Therapy for Severe Pneuomcystis Pneumonia in Acquired Immunodeficiency Syndrome (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_4775; Antibiotics were de-escalated to azithromycin 1200 mg every week for Mycobacterium avium prophylaxis and clindamycin-primaquine with prednisone for 21 days. This case serves to alert providers to appropriate salvage therapy in severe pneumocystis pneumonia when TMP-SMX is contraindicated and can contribute to the dearth of positive data for clindamycin-primaquine in severe pneumocystis pneumonia.
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