efavirenz / Generic mfg. 
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  • ||||||||||  Journal:  The quality of antiretroviral medicines: an uncertain problem. (Pubmed Central) -  Mar 20, 2023   
    The 95-95-95 target for 2026 and other international targets could be greatly hampered if even 1% of the millions of people taking ARV (for both prevention and prophylaxis) receive medicines that do not meet quality standards. More surveillance of SF ARV is needed to ensure issues are detected.
  • ||||||||||  efavirenz / Generic mfg.
    Journal:  Efavirenz-Based Antiretroviral Therapy but Not Pregnancy Increased Unbound Piperaquine Exposure in Women during Malaria Chemoprevention. (Pubmed Central) -  Mar 15, 2023   
    The results suggest that the impact of pregnancy and EFV-based ART on the exposure and, in turn, the efficacy of PQ for malaria prevention may not be as significant as was suggested by the changes in the total PQ exposure. Further study during the terminal elimination phase (e.g., on day 28 post-dose) would help better characterize the unbound PQ exposure during the full dosing interval and, thus, the overall efficacy of PQ for malaria chemoprevention in this special population.
  • ||||||||||  efavirenz / Generic mfg.
    Journal:  Stability and intrinsic dissolution of vacuum compression molded amorphous solid dispersions of efavirenz. (Pubmed Central) -  Mar 13, 2023   
    While the EFV intrinsic dissolution rates from the VCM ASDs were partly depending on the polymer dissolution rate, no correlation was observed between EFV matrix crystallization and its miscibility in the polymer. Altogether, the observations of the study underline the importance of combining preformulation miscibility determination and dissolution studies to rationally decide on both stability and viability of ASD formulations.
  • ||||||||||  Nexplanon (etonogestrel implant) / Organon
    Trial completion:  Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women (clinicaltrials.gov) -  Mar 13, 2023   
    P2,  N=72, Completed, 
    Altogether, the observations of the study underline the importance of combining preformulation miscibility determination and dissolution studies to rationally decide on both stability and viability of ASD formulations. Active, not recruiting --> Completed
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Cost-Effectiveness of Dolutegravir Versus Efavirenz-Based Combined Antiretroviral Regimens in HIV Infected Treatment-Na () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_825;    
    In conclusion, 3D spheroid PHHs is a valid model to investigate mRNA and protein induction of hepatic drug-metabolizing enzymes and transporters, and this model provides a solid basis to study induction of CYPs and transporters, which translates to clinical relevance. DTG- based regimen is associated with a higher cost of treatment compared to EFV-based regimen and was more effective in treating HIV na
  • ||||||||||  efavirenz / Generic mfg.
    Synthesis of various structural analogs of efavirenz (Virtual Session (Virtual Only)) -  Feb 14, 2023 - Abstract #ACSSp2023ACS_SP_4372;    
    Efforts toward the synthesis of higher order analogs including cyclobutylacetlylene and cyclopentylaceytlene will be discussed. Various reaction paramitters will be included.
  • ||||||||||  efavirenz / Generic mfg.
    Journal:  Late-onset efavirenz toxicity: A descriptive study from Pretoria, South Africa. (Pubmed Central) -  Feb 9, 2023   
    Recent changes in guidelines favour dolutegravir, but many patients remain on efavirenz, and awareness of the condition is vital. This large, single-centre study contributes to the limited data of HIV-positive patients with late-onset efavirenz toxicity and emphasises its ongoing relevance in clinical practice.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment closed, Trial primary completion date:  Biktarvy in Treatment-Na (clinicaltrials.gov) -  Feb 8, 2023   
    P4,  N=250, Active, not recruiting, 
    This large, single-centre study contributes to the limited data of HIV-positive patients with late-onset efavirenz toxicity and emphasises its ongoing relevance in clinical practice. Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Dec 2022
  • ||||||||||  edralbrutinib (TG-1701) / TG Therap
    Trial completion:  A Trial of DDI Between SHR1459 and Efavirenz With Healthy Subjects (clinicaltrials.gov) -  Feb 2, 2023   
    P1,  N=20, Completed, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Dec 2022 Active, not recruiting --> Completed
  • ||||||||||  lumacaftor (VX-809) / Vertex
    Review, Journal:  The impact of N-nitrosamine impurities on clinical drug development. (Pubmed Central) -  Jan 29, 2023   
    Consequent interruption or discontinuation of the manufacturing and distribution of several marketed drugs has culminated into shortages of marketed drugs, including the antidiabetic drug metformin and the potentially life-saving drug rifampin for the treatment of tuberculosis...In particular, rifampin is a key clinical index drug employed in drug-drug interaction (DDI) studies, and as a result of nitrosamine impurities regulatory bodies no longer accept the administration of rifampin in DDI studies involving healthy subjects. Drug developers are now forced to look at alternative approaches for commonly employed perpetrators, which will be discussed in this review.
  • ||||||||||  artemether/lumefantrine / Generic mfg.
    Journal:  Artemether-lumefantrine efficacy among adults on antiretroviral therapy in Malawi. (Pubmed Central) -  Jan 29, 2023   
    Nevertheless, lumefantrine levels tend to be low in this population, particularly in those on efavirenz-based regimens, with lower concentrations associated with more frequent malaria infections following treatment. These results highlight the importance of understanding drug-drug interactions when diseases commonly co-occur.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Retrospective data, Journal, Metastases:  A retrospective clinical study of dolutegravir- versus efavirenz-based regimen in treatment-naïve patients with advanced HIV infection in Nanjing, China. (Pubmed Central) -  Jan 27, 2023   
    Age (P < 0.001), baseline CD4+ T-cell count (P < 0.001), baseline VL (P < 0.001) and ART regimens (P = 0.019) were associated with the CD4+ T-cell count ≥ 350 cells/μL after adjusting for potential confounders. Among ART-naïve adults with advanced HIV infection, it appeared that DTG-based regimens were better options for initial therapy compared to regimens including EFV; in addition, ART regimens, age, baseline VL and CD4+ T-cell count were associated with immune recovery.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  The effect of ARVs on the MEKKK1 gene promoter, inflammatory cytokine expression and signalling in acute treated Jurkat T cells. (Pubmed Central) -  Jan 14, 2023   
    ARVs decreased IL-10 gene expression, showing no anti-inflammatory activity.The data shows that the inflammation caused by ARVs is not related to the methylation status of MEKKK1 gene promoter and suggests an alternative stimulus via post-transcriptional/post-translational modifications may activate the canonical MEKKK1/NFκB pathway that leads to inflammation. Finally, an increase in NFκB activity and pro-inflammatory cytokine activation seemed to occur via the MAPK/ERK pathway following ARV treatments in Jurkat T cells.
  • ||||||||||  ganaplacide (KAF156) / Novartis
    Trial completion, Enrollment change:  Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz (clinicaltrials.gov) -  Jan 12, 2023   
    P1,  N=14, Completed, 
    Finally, an increase in NFκB activity and pro-inflammatory cytokine activation seemed to occur via the MAPK/ERK pathway following ARV treatments in Jurkat T cells. Recruiting --> Completed | N=60 --> 14
  • ||||||||||  atazanavir / Generic mfg., efavirenz / Generic mfg., ritonavir / Generic mfg.
    Journal:  HIV-Tat Exacerbates the Actions of Atazanavir, Efavirenz, and Ritonavir on Cardiac Ryanodine Receptor (RyR2). (Pubmed Central) -  Jan 9, 2023   
    Collectively, these new data show that HIV-Tat, ATV, EFV, and RTV can bind to and modulate the activity of RyR2 and that HIV-Tat can exacerbate the actions of ATV, EFV, and RTV on RyR2. Whether the modulation of RyR2 by these agents increases the risk of arrhythmias and SCD remains to be explored.
  • ||||||||||  efavirenz / Generic mfg., artemether/lumefantrine / Generic mfg.
    Enrollment open:  OPTIMAL: Optimizing Malaria Treatment for HIV-Malaria Co-infected Individuals (clinicaltrials.gov) -  Jan 6, 2023   
    P4,  N=888, Recruiting, 
    The use of the pot-plant system can be recommended because it closely relates to the agricultural world. Not yet recruiting --> Recruiting
  • ||||||||||  metformin / Generic mfg., efavirenz / Generic mfg., fluoxetine / Generic mfg.
    Journal:  Combination of metformin/efavirenz/fluoxetine exhibits profound anticancer activity via a cancer cell-specific ROS amplification. (Pubmed Central) -  Jan 3, 2023   
    Oral administration with M + E + F combination for 3 weeks caused dramatic reductions in tumor volume and weight in HCT116 xenograft model of nude mice when compared with untreated ones. Our results suggest that M + E + F have profound anticancer activity both in vitro and in vivo via a cancer cell-specific ROS amplification (CASRA) through ROS-induced DNA damage, apoptosis, autophagy, and necroptosis.
  • ||||||||||  efavirenz / Generic mfg.
    Biomarker, Journal:  Pharmacogenetics of CYP2A6, CYP2B6, and UGT2B7 in the Context of HIV Treatments in African Populations. (Pubmed Central) -  Dec 24, 2022   
    A subset of variants of clinical interest with statistically significant inter-population frequency differences was identified for further inspection, which provides evidence of an African population-specific variant frequency profile. This study highlights the need for additional research and African genetics data given the presence of this unique frequency profile to better facilitate the genetic pre-screening of patients as a standard of practice in HIV care, particularly on the African continent where HIV is highly prevalent.
  • ||||||||||  Isentress (raltegravir) / Merck (MSD)
    Journal, Adherence:  Determinants of Antiretroviral Treatment Success and Adherence in People With Human Immunodeficiency Virus Treated for Tuberculosis. (Pubmed Central) -  Dec 22, 2022   
    Antiretroviral pill burden was the only factor associated with pill count adherence ratio ≥95% (OR, 0.81; 95% CI, .71-.92; P = .0018). In PWH with tuberculosis receiving raltegravir or efavirenz-based regimens, female sex, optimal adherence, and baseline HIV-1 RNA <100 000 copies/mL were associated with virologic success, and the number of antiretroviral tablets taken daily was a strong predictor of adherence.
  • ||||||||||  efavirenz / Generic mfg., rifampicin / Generic mfg.
    Journal:  A quantitative method for the study of HIV-1 and Mycobacterium tuberculosis co-infection. (Pubmed Central) -  Dec 21, 2022   
    We report that HIV-1 infection inhibited intracellular replication of M. tuberculosis and demonstrate the therapeutic activity of antiviral treatment (efavirenz) and antimicrobial treatment (rifampicin). The described method could be applied for detailed mechanistic studies to inform the development of novel treatment strategies.
  • ||||||||||  Preclinical, Journal:  In Vitro Susceptibility of HIV Isolates with High Growth Capability to Antiretroviral Drugs. (Pubmed Central) -  Dec 12, 2022   
    These antiretroviral drugs showed IC values close to or above the maximum plasma concentration against HIV isolates with high growth capability without any known drug resistance-related mutation. Our results may contribute to the development of effective strategies to tailor and individualize antiretroviral therapy in patients harboring HIV isolates with high growth capability.
  • ||||||||||  edralbrutinib (TG-1701) / TG Therap
    Enrollment closed:  A Trial of DDI Between SHR1459 and Efavirenz With Healthy Subjects (clinicaltrials.gov) -  Dec 12, 2022   
    P1,  N=20, Active, not recruiting, 
    Our results may contribute to the development of effective strategies to tailor and individualize antiretroviral therapy in patients harboring HIV isolates with high growth capability. Not yet recruiting --> Active, not recruiting