Tivicay (dolutegravir) / ViiV Healthcare 
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  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Journal, Adverse drug reaction:  Adverse drug reactions to integrase strand transfer inhibitors. (Pubmed Central) -  Sep 22, 2019   
    This study affirms INSTIs are well tolerated during routine clinical use. Consideration of differences in side effect profiles can inform ART individualization.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  AAHIV: Antiretroviral Therapy for Acute and Chronic HIV Infection (clinicaltrials.gov) -  Sep 19, 2019   
    P3,  N=621, Recruiting, 
    DTG demonstrated effectiveness in reducing VL with different kinetics in blood and semen, despite seminal viral suppression after 6 months of ART was not obtained in the totality of subjects. Trial completion date: Jul 2021 --> Jun 2033 | Trial primary completion date: Apr 2021 --> Jun 2033
  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Journal:  Accumulation of multiple mutations in vivo confers cross-resistance to new and existing integrase inhibitors. (Pubmed Central) -  Sep 18, 2019   
    The combination of major integrase inhibitor substitutions G140S/Q148H has been shown to confer high-level resistance to the approved integrase inhibitors raltegravir (RAL) and elvitegravir (EVG) but not necessarily dolutegravir (DTG)...The accumulation of multiple integrase substitutions confers high-level resistance to all five integrase inhibitors. There is extensive cross-resistance between DTG, BIC, and CAB (r = 0.96 - 0.97).
  • ||||||||||  Prezista (darunavir) / J&J, Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Changes in BMI Associated with Antiretroviral Regimens in Treatment-Experienced, Virologically Suppressed Individuals Living with HIV (Walter E. Washington Convention Center, 206) -  Sep 12, 2019 - Abstract #IDWeek2019IDWeek_779;    
    Small mean increases in BMI for all regimens were noted over time, for which the clinical significance is not yet known. Apparent differences in BMI changes favoring EVG/c, RAL and bDRV vs DTG over the short term were largely attenuated with longer follow-up, with significant differences mainly observed in those with a normal BMI at baseline.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Clinical, Journal, Monotherapy:  HIV-1 resistance dynamics in patients failing dolutegravir maintenance monotherapy. (Pubmed Central) -  Sep 12, 2019   
    P4
    The large variation in time-to-VF suggests that stochastic reactivation of a pre-existing provirus containing a single INSTI-RAM is the mechanism for failure. Changes in the 3'-PPT point to a new dolutegravir resistance mechanism in vivo.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Journal:  Resistance to dolutegravir--a chink in the armor? (Pubmed Central) -  Sep 11, 2019   
    Switching to DTG plus RPV improved viral suppression and LDL-C/HDL-C ratio. No abstract available
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Clinical, Journal:  What will it take to refute the possible safety signal for dolutegravir and neural tube defects? (Pubmed Central) -  Sep 10, 2019   
    Given the small number of events from a single study, more data are needed to confirm or refute this association. Difficulty finding these additional data highlights limitations of existing pharmacovigilance systems and challenges of combining disparate sources of data to understand rare but important events.
  • ||||||||||  Prezista (darunavir) / J&J, bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Review, Journal:  Simplifying ARV Therapy in the Setting of Resistance. (Pubmed Central) -  Sep 9, 2019   
    Currently, three- and two-drug ARV regimens may be considered in this population with most studies evaluating the use of DTG and bictegravir without baseline INSTI RAMs. Future studies should include heavily treatment-experienced patients with a variety of baseline RAMs and a larger sample size.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Journal:  Neural-Tube Defects and Antiretroviral Treatment Regimens in Botswana. (Pubmed Central) -  Sep 5, 2019   
    The prevalence of neural-tube defects was slightly higher in association with dolutegravir exposure at conception than with other types of ART exposure at conception (3 per 1000 deliveries vs. 1 per 1000 deliveries). (Funded by the National Institutes of Health.).
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Journal:  Dolutegravir-Based or Low-Dose Efavirenz-Based Regimen for the Treatment of HIV-1. (Pubmed Central) -  Sep 5, 2019   
    P3
    Among participants who had a viral load of at least 100,000 copies per milliliter when antiretroviral therapy was initiated, fewer participants than expected had viral suppression. (Funded by Unitaid and the French National Agency for AIDS Research; NAMSAL ANRS 12313 ClinicalTrials.gov number, NCT02777229.).
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
    Journal:  Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV. (Pubmed Central) -  Sep 5, 2019   
    P3
    There was significantly more weight gain with the DTG-containing regimens, especially in combination with TAF, than with the standard-care regimen. (ADVANCE ClinicalTrials.gov number, NCT03122262.).
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana (clinicaltrials.gov) -  Sep 3, 2019   
    P=N/A,  N=270, Recruiting, 
    These data suggest reduced monocyte activation following substitution of boosted PI with DTG, which could have important clinical implications. Trial completion date: Sep 2019 --> Mar 2020 | Trial primary completion date: Jul 2019 --> Jan 2020
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion:  Dolutegravir Plus 2 NRTIs, in Treatment-Na (clinicaltrials.gov) -  Sep 3, 2019   
    P2,  N=30, Completed, 
    Trial completion date: Sep 2019 --> Mar 2020 | Trial primary completion date: Jul 2019 --> Jan 2020 Recruiting --> Completed
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Virologic Failure In ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir Based Regimen () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2912;    
    Initiating on DTG or initiating therapy with a lower baseline VL was associated with a significant, reduced hazard of VF. Compared to DTG, the adjusted hazard ratio for VF was 1.29 (95% CI: 1.02, 1.63) for EVG.Conclusion : Among ART-naïve patients, DTG users were significantly less likely to experience virologic failure than EVG users after adjustment for important baseline covariates.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Real World Experience with Dolutegravir Plus Rilpivirine Two-Drug Regimen () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2910;    
    Physicians reported that most patients (91%) achieved the desired outcome from DTG+RPV use.Conclusion : Prior to commercial availability of DTG/RPV STR in the US, DTG+RPV was used primarily in treatment experienced patients, most commonly to avoid potential long-term toxicities. A high proportion of patients achieved the desired outcome and maintained virologic suppression while receiving DTG+RPV.
  • ||||||||||  Truvada (emtricitabine/tenofovir disoproxil fumarate) / Gilead, Tivicay (dolutegravir) / GSK, ViiV Healthcare
    HIV patient, recent Pneumocystis jirovecii (PCP) Pneumonia Treatment, now presenting with severe itching and jaundice. () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_1584;    
    In addition antiretroviral therapy was initiated with emtricitabine/tenofovir alafenamide and dolutegravir...After completing the three week treatment of intravenous ganciclovir, he was transitioned to valganciclovir 900mg tablet once daily...More data regarding the epidemiology, pathological processes, and natural history of the disease is needed to further understand clinical management in such cases. Final Diagnosis: AIDS Cholangiopathy due to Cytomegalovirus infection with Cytomegalovirus Hepatitis
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Weight gain among HIV-infected patients in Southern India on treatment with integrase strand transfer inhibitor-based anti-retroviral therapy () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_1137;    
    Background : Addition of integrase strand transfer-inhibitors (mainly dolutegravir) has strengthened anti-retroviral therapy (ART), to sustain viral suppression in HIV-1 and 2 infected patients...39% were initiated on TDF+3TC+DTG and 32% were initiated on TDF+FTC+DTG...Weight gain was positively correlated with time (r=+1); predicted increase in weight per 0.1 months after initiation of INSTI-based regimen (F=4.62, p=0.032). Conclusion : Access and adherence to INSTI have positively influenced viral suppression of HIV-infection.To ensure the prevention of obesity and apt use of ART for malnourished patients, it is imperative to monitor weight gain in patients who are initiated on INSTI-based regimens. Further research to study the mechanism of weight gain is warranted.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    Acute onset Diabetic Ketoacidosis/Hyperosmolar Hyperglycemic State in patients taking Integrase Strand Transfer Inhibitors () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_1117;    
    Background : A few case reports have noted uncontrolled hyperglycemia in patients switched to dolutegravir...The mechanism of action of INSTIs causing weight gain or an association with hyperglycemia is still under investigation.Conclusion : Although the temporal onset of DKA and HHS while receiving INSTIs was not precise, the possible association of INSTIs and their direct effects on insulin resistance and diabetes warrant additional attention from post-market data. Meanwhile, providers should monitor INSTI-treated patients closely, especially those with features of metabolic syndrome.
  • ||||||||||  Tivicay (dolutegravir) / GSK, ViiV Healthcare
    SWORD 1&2: Switch from TDF Containing Regimen to DTG+RPV Maintains Bone Mineral Density and Decreases Bone Turnover Markers Over 148 Weeks () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_1103;    
    The SWORD studies demonstrated noninferiority of the 2-drug regimen (2DR) dolutegravir (DTG) + rilpivirine (RPV) to continuing current triple-therapy ART (CAR) at 48 Wks and continued viral suppression on DTG+RPV through Wk 148...The favorable effects on skeletal health were observed despite the ageing of study pts and other factors decreasing BMD. A switch to DTG+RPV in suppressed pts provides a robust option for preserving bone health while continuing suppressive HIV treatment. 
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  Efficacy, Safety and Pharmacokinetics of DTG with RIF (clinicaltrials.gov) -  Aug 11, 2019   
    P2,  N=200, Recruiting, 
    No abstract available Not yet recruiting --> Recruiting | Trial completion date: Mar 2021 --> Jun 2021 | Initiation date: Mar 2019 --> Jun 2019 | Trial primary completion date: Mar 2021 --> Jun 2021