- |||||||||| lamivudine / Generic Mfg., Tivicay (dolutegravir) / ViiV Healthcare
Comparing NRTI-sparing dual regimens using data from the Swiss HIV cohort study (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_66; Estimates of relative effectiveness suggest that both dolutegravir regimens are not inferior to the alternative regimens used previously. Updated analyses show the stability of the earliest estimates with a slight gain in precision with each update.
- |||||||||| cabotegravir (GSK1265744) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
PK/PD data, Journal: Pharmacokinetics and Pharmacodynamics of Cabotegravir, a Long-Acting HIV Integrase Strand Transfer Inhibitor. (Pubmed Central) - Nov 14, 2019 Indeed, preclinical and clinical studies have consistently shown that LAI cabotegravir is readily absorbed following intramuscular and subcutaneous administration, with an elimination half-life of approximately 40 days, permitting infrequent dosing, possibly once every 1 or 2 months (eventually combined with rilpivirine). Here, we reviewed the existing literature on the preclinical and clinical pharmacokinetics and pharmacodynamics of LAI cabotegravir, with emphasis on the actual pharmacokinetic challenges of this novel formulation, as well as its potential to act as a victim or perpetrator of drug-drug interactions.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Safety and efficacy of dolutegravir in hemodialysis. (Pubmed Central) - Nov 10, 2019 Eighty percent of the patients were virally suppressed at six months with 62.5% of those suppressed maintaining suppression and 37.5% achieving suppression over the course of the six months. In a retrospective review of ten patients receiving dolutegravir while on hemodialysis for at least six months, dolutegravir was generally safe and effective for use at standard dosages.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Dolutegravir Resistance and Failure in a Kenyan Patient. (Pubmed Central) - Nov 8, 2019 In this large cohort representative of PLWH in care in the US, ART-naïve PLWH prescribed DTG had better virologic outcomes than RAL and DRV, but had virologic failure risks comparable to EVG, although RAL and DRV were preferentially prescribed to sicker individuals. No abstract available
- |||||||||| Clinical, Journal: Drug-Drug Interactions Studies between HCV Antivirals Sofosbuvir/Velpatasvir and Boosted and Unboosted HIV Antiretroviral Regimens in Healthy Volunteers. (Pubmed Central) - Nov 6, 2019
SOF/VEL and ARV regimens were administered alone and in combination; ARVs (and pharmacokinetic enhancers) included atazanavir (ATV), cobicistat (COBI), darunavir (DRV), dolutegravir (DTG), efavirenz (EFV), elvitegravir (EVG), emtricitabine (FTC), lopinavir (LPV), raltegravir (RAL), rilpivirine (RPV), ritonavir (RTV), tenofovir alafenamide (TAF), and tenofovir disoproxil fumarate (TDF)...No clinically relevant differences in the pharmacokinetics (PK) of SOF, SOF metabolite GS-331007, or VEL were observed other than an approximate 50% decrease in VEL exposure when administered with EFV/FTC/TDF...SOF/VEL and ARV regimens including ATV, COBI, DRV, DTG, EVG, FTC, LPV, RAL, RPV, RTV, TAF, or TDF may be coadministered without dose adjustment. Use of SOF/VEL with EFV-containing regimens is not recommended due to ~50% reduction in VEL exposure.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Two cases of dolutegravir failure with R263K mutation. (Pubmed Central) - Oct 31, 2019 Our results suggest continual assessment of total cholesterol among young children initiating a LPV/r-based regimen to monitor cardiometabolic health. No abstract available
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
Journal: The transition to dolutegravir and other new antiretrovirals in low- and middle-income countries - what are the issues? (Pubmed Central) - Oct 29, 2019 Most of these patients are using the combination of tenofovir (TDF), lamivudine (3TC) and efavirenz (EFV)...The prodrug of TDF, tenofovir alafenamide (TAF) is cheaper to manufacture than TDF...However, the clinical development programmes for DTG and TAF did not include extensive analysis of several key populations: pregnant women, people with HIV-tuberculosis (TB) coinfection taking rifampicin-based treatment, and treatment-naive or pretreated patients with NRTI drug resistance...Clinical trials of new antiretrovirals in key populations should be conducted earlier in their development. This will ensure that new treatments can be introduced into LMICs soon after their launch in high-income countries.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Analyses of HIV-1 integrase sequences prior to South African national HIV-treatment program and available of integrase inhibitors in Cape Town, South Africa. (Pubmed Central) - Oct 27, 2019 Furthermore, protein modeling showed, naturally occurring polymorphisms impact the stability of the intasome-complex and therefore may contribute to an overall potency against InSTIs. Our data suggest the prevalence of InSTI RAMs, against InSTIs, is low in South Africa, but natural polymorphisms and subtype-specific differences may influence the effect of individual treatment regimens.
- |||||||||| Truvada (emtricitabine/tenofovir disoproxil fumarate) / Gilead, Tivicay (dolutegravir) / GSK, ViiV Healthcare
Journal: Emergence of Integrase Resistance Mutations During Initial Therapy Containing Dolutegravir. (Pubmed Central) - Oct 27, 2019 Dolutegravir (DTG) is a preferred drug for initial treatment of human immunodeficiency virus type 1 infection. We present next-generation sequencing analysis of integrase genotypes during a period of virologic failure in a treatment-naive man who initiated tenofovir disoproxil fumarate/emtricitabine plus DTG.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare
Review, Journal: Antiretroviral treatment for HIV: is it time for 2 drug regimens? (Pubmed Central) - Oct 27, 2019 We present next-generation sequencing analysis of integrase genotypes during a period of virologic failure in a treatment-naive man who initiated tenofovir disoproxil fumarate/emtricitabine plus DTG. No abstract available
- |||||||||| Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, Journal: Prevalence of drug resistance in children recently diagnosed with HIV-1 infection in France (2006-17): impact on susceptibility to first-line strategies. (Pubmed Central) - Oct 10, 2019 The prevalence of PI-, NRTI-, efavirenz/nevirapine-, etravirine/rilpivirine- and doravirine-associated RAMs was 0%, 3.6%, 6.0%, 11.9% and 2.4%, respectively...Additionally, 3/60 (5%) strains had integrase inhibitor (INI)-related RAMs (an isolated E157Q mutation, which could mostly affect the susceptibility to raltegravir/elvitegravir rather than that to dolutegravir)...The proportion of NRTI- and NNRTI-related TDR in children is lower in France than in low- and middle-income countries. However, we suggest favouring PI- or dolutegravir- over NNRTI-based combinations to treat newly diagnosed HIV-infected children, even in the absence of previous exposure to antiretroviral prophylaxis of MTCT.
- |||||||||| Prezista (darunavir) / J&J, Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Preclinical, Journal: Differential Effects of Antiretroviral Drugs on Neurons In Vitro: Roles for Oxidative Stress and Integrated Stress Response. (Pubmed Central) - Oct 9, 2019 Further, we expanded our assessment to include three integrase strand transfer inhibitors, raltegravir, dolutegravir, and elvitegravir...Future in vivo studies will be critical to confirm the neurotoxicity profiles of these drugs for incorporation of these findings into patient management. The EAR and ISR pathways are potential access points for the development of adjunctive therapies to complement antiretroviral therapies and limit their contribution to HAND persistence.
- |||||||||| PK/PD data, Journal: Pharmacokinetics of Tenofovir Alafenamide When Co-administered With Other HIV Antiretrovirals. (Pubmed Central) - Oct 9, 2019
The EAR and ISR pathways are potential access points for the development of adjunctive therapies to complement antiretroviral therapies and limit their contribution to HAND persistence. Evaluation of the drug interaction between TAF and other commonly prescribed boosted and unboosted ARVs provides characterization of the susceptibility of TAF and/or TFV PK to inhibitors or inducers of Pgp/BCRP transporters.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare
Journal: Genital HIV-1 Shedding with Dolutegravir (DTG) plus Lamivudine (3TC) Dual Therapy. (Pubmed Central) - Oct 8, 2019 Evaluation of the drug interaction between TAF and other commonly prescribed boosted and unboosted ARVs provides characterization of the susceptibility of TAF and/or TFV PK to inhibitors or inducers of Pgp/BCRP transporters. No abstract available
- |||||||||| 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) - Oct 8, 2019 P=N/A, N=30, Recruiting, No abstract available Trial completion date: Sep 2019 --> Sep 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare
Journal: HIV-1 integrase inhibitors that are broadly effective against drug-resistant mutants. (Pubmed Central) - Sep 28, 2019 Of the three FDA-approved INSTIs, dolutegravir (DTG) is the least apt to select for resistance...Two of the new compounds, 4c and 4d, had superior antiviral profiles against the mutants we tested compared to DTGThe susceptibility profiles of 4c and 4d suggest that these compounds are candidates for development as INSTIs. Modeling the binding of 4d to HIV-1 IN reinforced the significance of mimicking the DNA substrate in developing compounds that broadly effective in their ability to inhibit HIV-1 INs with mutations in the active site.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, Journal: Integrase strand-transfer inhibitors for treatment of early HIV infection: A case series. (Pubmed Central) - Sep 27, 2019 Furthermore, subgroup sensitivity analyses failed to detect significant correlations based on definite or probable diagnoses, treatment using elvitegravir or dolutegravir, or the time from HIV diagnosis to ART initiation.This series of EHI cases indicate that using ART with ISTI-based regimens is efficacious and well-tolerated. However, earlier initiation of treatment was not significantly correlated with common parameters of immunological recovery.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare, Sovaldi (sofosbuvir) / Gilead
RESOLUTION OF HEPATOPULMONARY SYNDROME WITH SUCCESSFUL TREATMENT OF CHRONIC HEPATITIS C INFECTION (Ernest N. Morial Convention Center - Exhibit Hall - Poster Area 2) - Sep 25, 2019 - Abstract #CHEST2019CHEST_2754; For her HCV, the patient was later started on a 12-week course of sofosbuvir, velpatasvir and ribavarin, which was confirmed to have eliminated her HCV infection at 24 weeks post-treatment...In conclusion this case report describes the successful reversal of HPS following the treatment of chronic HCV infection. These findings suggests that further research may discover a role for the use of DAAs in treatment of HPS.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial completion: Dolutegravir Pediatric Liquid Formulation Study (clinicaltrials.gov) - Sep 22, 2019 P1, N=22, Completed, Active, not recruiting --> Completed Active, not recruiting --> Completed
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