- |||||||||| Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
New P3 trial: ALTAR: Reducing Antiretroviral Treatments (clinicaltrials.gov) - Aug 8, 2019 P3, N=360, Not yet recruiting,
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare
Journal: Nanoformulated Antiretroviral Therapy Attenuates Brain Metabolic Oxidative Stress. (Pubmed Central) - Aug 8, 2019 ...To address this, dolutegravir (Tivicay, DTG), a potent and durable HIV integrase inhibitor used effectively in combination ART was tested...Surprisingly, the oxidative stress-related metabolites were completely attenuated when DTG was administered as nanoformulations. These data demonstrate the importance of formulation design in control of DTG or perhaps other antiretroviral drug-associated CNS events.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Enrollment closed, Trial completion date, Trial primary completion date: Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept. (clinicaltrials.gov) - Aug 7, 2019 P2, N=40, Active, not recruiting, These data demonstrate the importance of formulation design in control of DTG or perhaps other antiretroviral drug-associated CNS events. Recruiting --> Active, not recruiting | Trial completion date: Jun 2019 --> Jul 2021 | Trial primary completion date: Apr 2019 --> May 2021
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare
Journal: HIV in 2019: it's all about dolutegravir. (Pubmed Central) - Aug 2, 2019 INSTI core agents had superior efficacy and similar safety to PIs and NNRTIs at Week 48 in treatment-naïve patients with HIV-1, with DTG being among the most efficacious, including in patients with baseline VL > 100,000copies/mL or ≤ 200 CD4cells/μL, who can be difficult to treat. No abstract available
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare, Epzicom (abacavir/lamivudine) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
Clinical, Journal: Adipocytes impair efficacy of antiretroviral therapy. (Pubmed Central) - Aug 1, 2019 In HIV-infected persons, LC-MS/MS analysis of intracellular lysates derived from adipose tissue stromal-vascular-fraction cells or mature adipocytes suggested that integrase inhibitors penetrate adipose tissue, whereas penetration of nucleoside/nucleotide reverse transcriptase inhibitors such as TDF, emtricitabine, abacavir, and lamivudine is restricted. The limited distribution and functions of key antiretroviral drugs within fat depots may contribute to viral persistence in adipose tissue.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Probing Resistance Mutations in Retroviral Integrases by Direct Measurement of Dolutegravir Fluorescence. (Pubmed Central) - Jul 26, 2019 Accordingly, the two latter mutants are highly resistant to dolutegravir while F190Y shows only moderate or no resistance. Intrinsic fluorescence properties of dolutegravir are thus particularly suitable for a thorough characterization of both DNA-binding properties of integrase and resistance mutations.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal, Monotherapy: Dolutegravir resistance mutations: lessons from monotherapy studies. (Pubmed Central) - Jul 21, 2019 Infant elimination is prolonged, with half-life over twice that of historical adult controls. Monotherapy with dolutegravir has a high rate for resistance selection in the integrase gene through different pathways in case of virological failure.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Absence of HIV-1 drug resistance mutations supports the use of dolutegravir in Uganda. (Pubmed Central) - Jul 19, 2019 Of fourteen drugs currently available for cART in Uganda, resistance was readily observed to all antiretroviral drugs (except for DTG) in Ugandan patients failing first-, second-, or even third-line treatment regimens. The high NNRTI resistance in first line treatment in Uganda even among treatment naïve patients, calls for the use of DTG to reach the UNAIDS 90:90:90 goals.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare
Journal: Efficient biosynthesis of (R)-3-amino-1-butanol by a novel (R)-selective transaminase from Actinobacteria sp. (Pubmed Central) - Jul 17, 2019 (R)-3-amino-1-butanol is a key intermediate of Dolutegravir for the treatment of HIV/AIDS and its green and efficient biosynthesis has attracted a great deal of attention...(R)-3-amino-1-butanol with a maximum yield of 29.6 g/L and 99.9% e.e. value was obtained. This was the first time demonstrating the successful biosynthesis of (R)-3-amino-1-butanol with transaminase as biocatalyst and the obtained As-TA enriched the enzyme pool of transaminase with (R)-specificity.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare
Clinical, Journal: Risk of elevation of serum creatine kinase among HIV-positive individuals receiving dolutegravir-based combination antiretroviral therapy. (Pubmed Central) - Jul 11, 2019 While dolutegravir group had a higher rate of CK elevation of any level than non-InSTI group (22.9 vs 17.4 per 100 PYFU, P = .01), the risk was associated with weight (adjusted odds ratio [aOR], per 10-kg increase, 1.03; 95% CI, 1.02-1.04), duration of exercise (aOR, per 1-hour increase, 1.02; 95% CI 1.01-1.03), but not with dolutegravir-based ART (aOR, 1.00; 95% CI, 0.99-1.06) after adjusting for the testing frequency of serum CK in the multivariate generalized estimating equation model. No patients were hospitalized or switched ART due to CK elevation.Serum CK elevation was associated with weight and duration of exercise among HIV-positive patients receiving ART, but not with dolutegravir-based ART.
- |||||||||| Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Pathway involving the N155H mutation in HIV-1 integrase leads to dolutegravir resistance. (Pubmed Central) - Jun 28, 2019 Our results indicate that the stability of STI IN/DNA complexes is an important parameter that must be taken into account when evaluating dolutegravir resistance. This study confirms that a pathway including N155H can be selected in patients treated with dolutegravir with the help of the polymorphic K156N that acts as a secondary mutation that enhances the resistance to dolutegravir.
- |||||||||| Zinbryta (daclizumab) / Biogen, AbbVie, Tivicay (dolutegravir) / GSK, ViiV Healthcare
Journal, Adverse events: Pharmacovigilance update (Pubmed Central) - Jun 26, 2019 Cobicistat-boosted antiretrovirals exposure is decreased during pregnancy. Fourth generation pills containing drospirenone : a greater propensity to prolong the QT interval than 2nd generation pills.
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