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  • 1
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    Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials
    Elsevier BV ; 2023
    In:  The Lancet HIV ( 2023-12)
    Details
    In: The Lancet HIV, Elsevier BV, ( 2023-12)
    Type of Medium: Online Resource
    ISSN: 2352-3018
    URL: Article
    DOI: 10.1016/S2352-3018(23)00258-8
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
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  • 2
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    Sustained Antiretroviral Effect of Raltegravir After 96 Weeks of Combination Therapy in Treatment-Naive Patients With HIV-1 Infection
    Ovid Technologies (Wolters Kluwer Health) ; 2009
    In:  JAIDS Journal of Acquired Immune Deficiency Syndromes Vol. 52, No. 3 ( 2009-11), p. 350-356
    Details
    In: JAIDS Journal of Acquired Immune Deficiency Syndromes, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. 3 ( 2009-11), p. 350-356
    Type of Medium: Online Resource
    ISSN: 1525-4135
    URL: Article
    DOI: 10.1097/QAI.0b013e3181b064b0
    RVK:
    XA 10000
    RVK:
    XA 51942
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2009
    detail.hit.zdb_id: 2038673-4
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  • 3
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    Pharmacokinetics and Pharmacodynamics of Once-Daily versus Twice-Daily Raltegravir in Treatment-Naïve HIV-Infected Patients
    American Society for Microbiology ; 2012
    In:  Antimicrobial Agents and Chemotherapy Vol. 56, No. 6 ( 2012-06), p. 3101-3106
    Details
    In: Antimicrobial Agents and Chemotherapy, American Society for Microbiology, Vol. 56, No. 6 ( 2012-06), p. 3101-3106
    Abstract: QDMRK was a phase III clinical trial of raltegravir given once daily (QD) (800-mg dose) versus twice daily (BID) (400 mg per dose), each in combination with once-daily coformulated tenofovir-emtricitabine, in treatment-naive HIV-infected patients. Pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analyses were conducted using a 2-step approach: individual non-model-based PK parameters from observed sparse concentration data were determined, followed by statistical analysis of potential relationships between PK and efficacy response parameters after 48 weeks of treatment. Sparse PK sampling was performed for all patients (QD, n = 380; BID, n = 384); selected sites performed an intensive PK evaluation at week 4 (QD, n = 22; BID, n = 20). In the intensive PK subgroup, daily exposures (area under the concentration-time curve from 0 to 24 h [AUC 0–24 ]) were similar between the two regimens, but patients on 800 mg QD experienced ∼4-fold-higher maximum drug concentration in plasma ( C max ) values and ∼6-fold-lower trough drug concentration ( C trough ) values than those on 400 mg BID. Geometric mean (GM) C trough values were similarly lower in the sparse PK analysis. With BID dosing, there was no indication of any significant PK/PD association over the range of tested PK parameters. With QD dosing, C trough values correlated with the likelihood of virologic response. Failure to achieve an HIV RNA level of 〈 50 copies/ml appeared predominantly at high baseline HIV RNA levels in both treatment arms and was associated with lower values of GM C trough in the 800-mg-QD arm, though other possible drivers of efficacy, such as time above a threshold concentration, could not be evaluated due to the sparse sampling scheme. Together, these findings emphasize the importance of the shape of the plasma concentration-versus-time curve for long-term efficacy.
    Type of Medium: Online Resource
    ISSN: 0066-4804 , 1098-6596
    URL: Article
    DOI: 10.1128/AAC.06417-11
    RVK:
    XA 24552
    Language: English
    Publisher: American Society for Microbiology
    Publication Date: 2012
    detail.hit.zdb_id: 1496156-8
    SSG: 12
    SSG: 15,3
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  • 4
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    Pharmacokinetics, Tolerability, and Safety of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Week 24 Results From IMPAACT 2014
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  JAIDS Journal of Acquired Immune Deficiency Syndromes Vol. 92, No. 2 ( 2023-02-1), p. 153-161
    Details
    In: JAIDS Journal of Acquired Immune Deficiency Syndromes, Ovid Technologies (Wolters Kluwer Health), Vol. 92, No. 2 ( 2023-02-1), p. 153-161
    Abstract: We studied the pharmacokinetics (PK) and safety of 100-mg doravirine and doravirine/lamivudine/tenofovir disoproxil fumarate fixed-dose combination (100/300/300 mg DOR FDC) treatment in adolescents with HIV-1. Methods: Adolescents ages 12 to younger than 18 years were enrolled in 2 sequential cohorts. Cohort 1 evaluated intensive PK and short-term safety of 100-mg single-dose doravirine in adolescents ≥35 kg. Cohort 2 participants either initiated treatment with DOR FDC (antiretroviral (ARV)-naïve) or switched to DOR FDC from a previous ARV regimen (virologically suppressed). The first 10 Cohort 2 participants had intensive PK evaluations, and safety, sparse PK, and HIV RNA were assessed through week 24. Results: Fifty-five adolescents, median age 15.0 years and baseline weight 51.5 kg, were enrolled. Nine participants completed Cohort 1 PK assessments (8 of the 9 participants weighed ≥45 kg) and 45 initiated study drug in Cohort 2. The doravirine geometric mean (GM) AUC 0–∞ was 34.8 μM∙hour, and the GM C 24 was 514 nM after a single dose, with a predicted steady-state GM C 24,ss,pred of 690 nM. Cohort 2 enrolled adolescents weighing ≥45 kg. Plasma concentrations of doravirine, tenofovir, and lamivudine achieved by Cohort 2 participants were similar to those reported in adults. No drug-related serious or grade 3 or 4 adverse events occurred. Forty-two of 45 participants (93.3%; 95% CI: [81.7, 98.6]) achieved or maintained HIV-1 RNA 〈 40 copies/mL. Conclusions: Doravirine and DOR FDC achieved target PK in adolescents with HIV-1. DOR FDC was well-tolerated and maintained excellent virologic efficacy through 24 weeks, offering a favorable option for adolescents.
    Type of Medium: Online Resource
    ISSN: 1525-4135
    URL: Article
    DOI: 10.1097/QAI.0000000000003116
    RVK:
    XA 10000
    RVK:
    XA 51942
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2038673-4
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  • 5
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    1169. In Vitro Activity of Posaconazole versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults Enrolled in a Clinical Trial
    Oxford University Press (OUP) ; 2020
    In:  Open Forum Infectious Diseases Vol. 7, No. Supplement_1 ( 2020-12-31), p. S609-S610
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 7, No. Supplement_1 ( 2020-12-31), p. S609-S610
    Abstract: Invasive aspergillosis (IA) is a life-threatening disease with limited treatment options and is associated with delays in effective treatment and significant early mortality. Posaconazole (POS) is a broad-spectrum triazole antifungal, that exhibits potent activity against yeasts and molds. We evaluated the antifungal susceptibility profiles of isolates collected during a randomized, prospective, phase 3, double-blind, double-dummy study comparing posaconazole with voriconazole (1:1 randomization) given for ≤12 weeks in the primary treatment of IA (ClinicalTrials.gov, NCT01782131; EudraCT, 2011-003938-14) using CLSI and EUCAST reference testing methodologies. Methods More than 90 study sites located in 23 countries enrolled subjects in the clinical trial. A total of 127 isolates were recovered from documented infections during 2013 through 2019. Fungal isolates were identified using molecular methods and antifungal susceptibility testing was performed by reference broth microdilution methods. The following antifungal agents tested were: posaconazole, itraconazole, voriconazole, caspofungin, and amphotericin B Results Of the 127 samples tested, 119 were identified as Aspergillus species. Aspergillus fumigatus (N=76) was the most prevalent species, followed by A. flavus species complex (N=19), A. section Nigri (N=10), A. section Terrei (N=7). Overall, posaconazole (MIC50/MIC 90, 0.5/1 mg/L) displayed similar activity to voriconazole (MIC50/MIC90, 0.5/1 mg/L) and itraconazole (MIC50/MIC90, 1/2 mg/L) against 119 Aspergillus species Isolates, by both, CLSI and EUCAST method. Posaconazole (MIC50/MIC90, 0.5/0.5 mg/L) and voriconazole (MIC50/MIC90, 0.25/0.5 mg/L) inhibited all 76 A. fumigatus isolates at MIC of 1 mg/L. Among 19 A. flavus species complex isolates recovered from this study, posaconazole (MIC50/MIC90, 0.5/1 mg/L), voriconazole (MIC50/MIC90, 1/1 mg/L) and itraconazole (MIC50/MIC90, 0.5/1 mg/L) displayed equivalent activity. Conclusion Posaconazole displayed good activity against all Aspergillus species isolates included in this study. In addition, posaconazole in vitro activity against Aspergillus species was similar to that observed by voriconazole and itraconazole. Disclosures Mariana Castanheira, PhD, 1928 Diagnostics (Research Grant or Support)A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Allergan (Research Grant or Support)Allergan (Research Grant or Support)Amplyx Pharmaceuticals (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Cipla Ltd. (Research Grant or Support)Cipla Ltd. (Research Grant or Support)Fox Chase Chemical Diversity Center (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Merck (Research Grant or Support)Merck (Research Grant or Support)Merck & Co, Inc. (Research Grant or Support)Merck & Co, Inc. (Research Grant or Support)Paratek Pharma, LLC (Research Grant or Support)Pfizer (Research Grant or Support)Qpex Biopharma (Research Grant or Support) Leah Woosley, n/a, Merck & Co, Inc. (Research Grant or Support) Mary Motyl, PhD, Merck & Co, Inc (Employee, Shareholder) Seongah Han, PhD, Merck & Co, Inc. (Employee) Havilland Campbell, BS, Merck & Co, Inc. (Employee)
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofaa439.1355
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2757767-3
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  • 6
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    Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial
    Elsevier BV ; 2011
    In:  The Lancet Infectious Diseases Vol. 11, No. 12 ( 2011-12), p. 907-915
    Details
    In: The Lancet Infectious Diseases, Elsevier BV, Vol. 11, No. 12 ( 2011-12), p. 907-915
    Type of Medium: Online Resource
    ISSN: 1473-3099
    URL: Article
    DOI: 10.1016/S1473-3099(11)70196-7
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2011
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  • 7
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    1161. Effectiveness of Posaconazole in the Treatment of Rare Invasive Fungal Infections: A Systematic Literature Review
    Oxford University Press (OUP) ; 2020
    In:  Open Forum Infectious Diseases Vol. 7, No. Supplement_1 ( 2020-12-31), p. S607-S607
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 7, No. Supplement_1 ( 2020-12-31), p. S607-S607
    Abstract: Rare invasive fungal infections (IFIs) such as chromoblastomycosis (CBM), fungal mycetoma (mycetoma), hyalohyphomycosis/phaeohyphomycosis (hyalo/phaeo), and mucormycosis (mucor) cause significant morbidity and mortality in immunocompromised patients. Few effective treatment options are available for these IFIs, therefore we assessed the clinical efficacy of posaconazole, a broad-spectrum triazole antifungal compound with demonstrated activity against IFIs. Methods We performed a systemic literature review of Medline and EMBASE to identify studies published from 2005 (year of posaconazole approval) to October 30, 2019, reporting the efficacy/effectiveness of posaconazole monotherapy or combination therapy for treating CBM, mycetoma, hyalo/phaeo, and mucor. Two reviewers screened and extracted data based on predefined PICOS criteria. Effectiveness outcomes included cure, response, relapse, radiologic improvement; mortality and any other effectiveness measures reported. Study quality was assessed using National Institute for Health and Care Excellence-recommended checklists. A narrative descriptive summary was used to summarize study findings. Results Of 2612 articles identified, 351 articles (mostly case reports) were included. Positive clinical outcomes with posaconazole therapy were observed in most patients with CBM (73.9%, 17/23), mycetoma (100%, 2/2), hyalo/phaeo (53.3%, 49/92), and mucor (66.7%, 564/845). The population for mycetoma was small; only 2 positive cases (Figure). Overall survival was ~70% or greater across the IFIs examined. Posaconazole efficacy and mortality differed by line of therapy as well as for monotherapy versus combination therapy. Positive response was higher in second line monotherapy than first line monotherapy in CBM and mucor. Higher mortality was observed with combination therapy than monotherapy in hyalo/phaeo and mucor infections (except for first line use in mucor). Figure. Overall Results of Posaconazole Treatment Conclusion Despite the rarity of these IFIs, substantial data have been published since posaconazole’s initial approval in the year 2005, and the evidence demonstrates that posaconazole is an effective therapeutic option alone or in combination for the treatment of these rare IFIs. Disclosures Mark Bernauer, BPharm, RPh, Merck & Co, Inc. (Consultant) Hetty Waskin, MD/MPH, Merck & Co, Inc. (Employee) Nicole Cossrow, PhD, Merck & Co, Inc. (Employee) Allysen Kaminski, BA, Merck & Co, Inc. (Consultant) Havilland Campbell, BS, Merck & Co, Inc. (Employee) Dipen Patel, BPharm, PhD, Merck & Co, Inc. (Consultant)
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofaa439.1347
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2757767-3
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  • 8
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    1148. Activity of Posaconazole and Comparator Antifungal agents Tested Against Filamentous Fungi
    Oxford University Press (OUP) ; 2020
    In:  Open Forum Infectious Diseases Vol. 7, No. Supplement_1 ( 2020-12-31), p. S601-S601
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 7, No. Supplement_1 ( 2020-12-31), p. S601-S601
    Abstract: Posaconazole (POS) is a broad-spectrum triazole antifungal that exhibits potent antifungal activity against a variety of yeasts and molds. We evaluated the in vitro activities of posaconazole and comparator antifungal agents against 2,554 isolates of filamentous fungi including 2,100 Aspergillus species and 454 non-Aspergillus moulds (98 Fusarium, 81 Mucorales and 76 Scedosporium species isolates) collected worldwide in 2010-2018 from clinically significant infections. Methods Isolates were identified using sequencing and/or MALDI-TOF MS methods. Posaconazole, itraconazole, voriconazole, caspofungin, anidulafungin, micafungin, and amphotericin B were tested using the reference broth microdilution method according to CLSI guidelines. Results Posaconazole showed comparable activity to itraconazole and voriconazole against A. fumigatus. Categorical agreement between posaconazole and the other azoles tested against A. fumigatus ranged from 98.2-98.7%. Most of the Aspergillus species isolates tested ( & gt;90%) were WT to all azoles and echinocandins. Among the isolates of A. fumigatus, the rate of NWT strains varied across the different geographic regions. The frequency of azole NWT strains of A. fumigatus from Europe increased steadily from 2010 to 2018. There was no consistent trend for an increased frequency of NWT strains from other geographic areas. The azoles and echinocandins showed poor activity against Fusarium and Scedosporium species. Posaconazole (MIC50/90, 1/2 mg/L) and amphotericin B (MIC50/90, 1/2 mg/L) were the most active agents against the Mucorales isolates. Conclusion Posaconazole exhibited excellent activity against most species of Aspergillus and was comparable to itraconazole and voriconazole. Most Aspergillus species remain susceptible to triazoles. Although there was no evidence for an increasing frequency of NWT strains among A. fumigatus isolates from North America, Latin America or the Asia-Pacific region, we confirm an increase in the rate of NWT strains to all three triazoles among isolates from Europe. Disclosures Mariana Castanheira, PhD, 1928 Diagnostics (Research Grant or Support)A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Allergan (Research Grant or Support)Allergan (Research Grant or Support)Amplyx Pharmaceuticals (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Cipla Ltd. (Research Grant or Support)Cipla Ltd. (Research Grant or Support)Fox Chase Chemical Diversity Center (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Merck (Research Grant or Support)Merck (Research Grant or Support)Merck & Co, Inc. (Research Grant or Support)Merck & Co, Inc. (Research Grant or Support)Paratek Pharma, LLC (Research Grant or Support)Pfizer (Research Grant or Support)Qpex Biopharma (Research Grant or Support) Cecilia G. Carvalhaes, MD, PhD, A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Allergan (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Cipla Ltd. (Research Grant or Support)Fox Chase Chemical Diversity Center (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Merck (Research Grant or Support)Merck (Research Grant or Support)Merck & Co, Inc. (Research Grant or Support)Pfizer (Research Grant or Support) Mary Motyl, PhD, Merck & Co, Inc (Employee, Shareholder) Seongah Han, PhD, Merck & Co, Inc. (Employee) Havilland Campbell, BS, Merck & Co, Inc. (Employee)
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofaa439.1334
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2757767-3
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  • 9
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    Efficacy, safety, and tolerability of doravirine/lamivudine/tenofovir disoproxil fumarate fixed dose combination tablets in adolescents living with HIV: results through week 96 from IMPAACT 2014
    Oxford University Press (OUP) ; 2023
    In:  Journal of the Pediatric Infectious Diseases Society ( 2023-10-10)
    Details
    In: Journal of the Pediatric Infectious Diseases Society, Oxford University Press (OUP), ( 2023-10-10)
    Abstract: IMPAACT 2014 study is a phase I/II, multicenter, open-label, non-randomized study of doravirine (DOR) co-formulated with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) as fixed dose combination (DOR FDC) in adolescents with HIV-1. We report the efficacy, safety, and tolerability of DOR FDC through 96 weeks. Methods Participants were adolescents aged 12 to & lt;18 years who weighed at least 45 kg and who were either antiretroviral (ARV)-naïve or virologically suppressed without documented resistance mutations to DOR/3TC/TDF. The efficacy endpoint was the proportion of participants with HIV-1 RNA & lt;40 copies/mL assessed at week 48 and 96 using the observed failure approach. Safety and tolerability outcomes were incidence of adverse events and treatment discontinuations. Results A total of 45 adolescents, median age 15 (range, 12 - 17) years, 58% females, were enrolled, 2 (4.4%) participants were ARV-naïve. Of the 45 participants, 42 (93.3%) completed the study and 41 (91.1%) completed study treatment. At week 48, 41/42 (97.6%; 95% confidence interval [CI], 87.4 - 99.9) and week 96, 37/40 (92.5%; 95% CI, 79.6 - 98.4) participants had achieved or maintained HIV-1 RNA & lt;40 copies/mL. There were no treatment-related discontinuations due to adverse events and no drug-related adverse events ≥ grade 3 or deaths. Conclusions We found once daily dosing of DOR FDC to be safe and well tolerated for maintaining viral suppression through 96 weeks in adolescents living with HIV-1.
    Type of Medium: Online Resource
    ISSN: 2048-7207
    URL: Article
    DOI: 10.1093/jpids/piad078
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2668791-4
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