82 research outputs found
Supplement_1 – Supplemental material for Intralesional Cidofovir for Treatment of Acyclovir-Resistant Laryngeal Herpes Manifesting as Supraglottic Mass
No full textSupplemental material, Supplement_1 for Intralesional Cidofovir for Treatment of Acyclovir-Resistant Laryngeal Herpes Manifesting as Supraglottic Mass by Charles Q. Yang, Anisha Mathur, Princy N. Kumar and Vaninder K. Dhillon in Annals of Otology, Rhinology & Laryngology</p
Collected Papers (on various scientific topics), Volume XII
No full textThis twelfth volume of Collected Papers includes 86 papers comprising 976 pages on Neutrosophics Theory and Applications, published between 2013-2021 in the international journal and book series “Neutrosophic Sets and Systems” by the author alone or in collaboration with the following 112 co-authors (alphabetically ordered) from 21 countries: Abdel Nasser H. Zaied, Muhammad Akram, Bobin Albert, S. A. Alblowi, S. Anitha, Guennoun Asmae, Assia Bakali, Ayman M. Manie, Abdul Sami Awan, Azeddine Elhassouny, Erick González-Caballero, D. Dafik, Mithun Datta, Arindam Dey, Mamouni Dhar, Christopher Dyer, Nur Ain Ebas, Mohamed Eisa, Ahmed K. Essa, Faruk Karaaslan, João Alcione Sganderla Figueiredo, Jorge Fernando Goyes García, N. Ramila Gandhi, Sudipta Gayen, Gustavo Alvarez Gómez, Sharon Dinarza Álvarez Gómez, Haitham A. El-Ghareeb, Hamiden Abd El-Wahed Khalifa, Masooma Raza Hashmi, Ibrahim M. Hezam, German Acurio Hidalgo, Le Hoang Son, R. Jahir Hussain, S. Satham Hussain, Ali Hussein Mahmood Al-Obaidi, Hays Hatem Imran, Nabeela Ishfaq, Saeid Jafari, R. Jansi, V. Jeyanthi, M. Jeyaraman, Sripati Jha, Jun Ye, W.B. Vasantha Kandasamy, Abdullah Kargın, J. Kavikumar, Kawther Fawzi Hamza Alhasan, Huda E. Khalid, Neha Andalleb Khalid, Mohsin Khalid, Madad Khan, D. Koley, Valeri Kroumov, Manoranjan Kumar Singh, Pavan Kumar, Prem Kumar Singh, Ranjan Kumar, Malayalan Lathamaheswari, A.N. Mangayarkkarasi, Carlos Rosero Martínez, Marvelio Alfaro Matos, Mai Mohamed, Nivetha Martin, Mohamed Abdel-Basset, Mohamed Talea, K. Mohana, Muhammad Irfan Ahamad, Rana Muhammad Zulqarnain, Muhammad Riaz, Muhammad Saeed, Muhammad Saqlain, Muhammad Shabir, Muhammad Zeeshan, Anjan Mukherjee, Mumtaz Ali, Deivanayagampillai Nagarajan, Iqra Nawaz, Munazza Naz, Roan Thi Ngan, Necati Olgun, Rodolfo González Ortega, P. Pandiammal, I. Pradeepa, R. Princy, Marcos David Oviedo Rodríguez, Jesús Estupiñán Ricardo, A. Rohini, Sabu Sebastian, Abhijit Saha, Mehmet Șahin, Said Broumi, Saima Anis, A.A. Salama, Ganeshsree Selvachandran, Seyed Ahmad Edalatpanah, Sajana Shaik, Soufiane Idbrahim, S. Sowndrarajan, Mohamed Talea, Ruipu Tan, Chalapathi Tekuri, Selçuk Topal, S. P. Tiwari, Vakkas Uluçay, Maikel Leyva Vázquez, Chinnadurai Veerappan, M. Venkatachalam, Luige Vlădăreanu, Ştefan Vlăduţescu, Young Bae Jun, Wadei F. Al-Omeri, Xiao Long Xin.
Efficacy and safety of raltegravir for treatment of HIV for 5 years in the benchmrk studies: final results of two randomised, placebo-controlled trials
No full textPrincipal investigators of BENCHMRK-1
Australia: A Allworth, J Anderson, M Bloch, D A Cooper, J Hoy,
C Workman. Belgium: N Clumeck, R Colebunders, M Moutschen;
Denmark: J Gerstoft, C Larsen, L Mathiesen, C Pedersen. France:
J F Delfraissy, P Dellamonica, C Katlama, J M Molina, F Raffi , J Reynes,
D Vittecoq, P Yeni. Germany: K Arasteh, G Fatkenheuer, H Jaeger,
J Rockstroh, A Stoehr. Italy: F Aiuti, G Carosi, R Cauda, F Chiodo,
G Di Perri, G Filice, M Galli, A Lazzarin, V Vullo. Peru: M Castaneda,
A Florez, F Mendo, A Paredes, R Salazar, E Ticona. Portugal: R Antunes,
A Diniz, K Mansinho, J Saraiva da Cunha, R Sarmento, E Teofi lo, J Vera.
Spain: J Arrizabalaga, B Clotet, P Domingo Pedrol, J Gatell Artigas,
S Moreno Guillen, V Soriano Vazquez. Switzerland: B Hirschel,
M Opravil. Taiwan: H-H Lin, W-H Sheng, J-H Wang. Thailand:
S Sungkanuparph, S Suwanagool. Principal investigators of BENCHMRK-2
Brazil: B Grinsztejn, J V Madruga, M Schecter. Canada: J-G Baril,
M R Loutfy, J S Montaner, C Tremblay, CM Tsoukas, S Vezina. Colombia:
J A Cortes, H Mendoza, J Velez. Mexico: N Quintero Perez, J Ramos,
E Rodriguez. Puerto Rico: J O Morales-Ramirez, G E Sepulveda. USA:
J Aberg, G W Beatty, P Benson, R K Bolon, U F Bredeek, C Bruno,
T Campbell, R Campo, G O Coodley, R B Corales, E DeJesus, J J Eron,
W J Fessel, R J Fetchick, C J Gonzalez, C Hicks, M A Horberg,
D B Klein, M J Kozal, P N Kumar, A LaMarca, J L Lennox,
K A Lichtenstein, R Liporace, S J Little, A Luetkemeyer, F Mariuz,
M Markowitz, D K McMahon, G Perez, G Pierone, R C Reichman,
F Rhame, P Shalit, P Sklar, W Short, P R Skolnik, R T Steigbigel,
E M Tedaldi, D J Ward, A A Wiznia, D P Wright.Background
Two randomised, placebo-controlled trials—BENCHMRK-1 and BENCHMRK-2—investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5 years (the end of the study).
Methods
Integrase-inhibitor-naive patients with HIV resistant to three classes of drug and who were failing antiretroviral therapy were enrolled. Patients were randomly assigned (2:1) to raltegravir 400 mg twice daily or placebo, both with optimised background treatment. Patients and investigators were masked to treatment allocation until week 156, after which all patients were offered open-label raltegravir until week 240. The primary endpoint was previously assessed at 16 weeks. We assessed long-term efficacy with endpoints of the proportion of patients with an HIV viral load of less than 50 copies per mL and less than 400 copies per mL, and mean change in CD4 cell count, at weeks 156 and 240.
Findings
1012 patients were screened for inclusion. 462 were treated with raltegravir and 237 with placebo. At week 156, 51% in the raltegravir group versus 22% in the placebo group (non-completer classed as failure) had viral loads of less than 50 copies per mL, and 54% versus 23% had viral loads of less than 400 copies per mL. Mean CD4 cell count increase (analysed by an observed failure approach) was 164 cells per μL versus 63 cells per μL. After week 156, 251 patients (54%) from the raltegravir group and 47 (20%) from the placebo group entered the open-label raltergravir phase; 221 (47%) versus 44 (19%) completed the entire study. At week 240, viral load was less than 50 copies per mL in 193 (42%) of all patients initially assigned to raltegravir and less than 400 copies per mL in 210 (45%); mean CD4 cell count increased by 183 cells per μL. Virological failure occurred in 166 raltegravir recipients (36%) during the double-blind phase and in 17 of all patients (6%) during the open-label phase. The most common drug-related adverse events at 5 years in both groups were nausea, headache, and diarrhoea, and occurred in similar proportions in each group. Laboratory test results were similar in both treatment groups and showed little change after year 2.
Interpretation
Raltegravir has a favourable long-term efficacy and safety profile in integrase-inhibitor-naive patients with triple-class resistant HIV in whom antiretroviral therapy is failing. Raltegravir is an alternative for treatment-experienced patients, particularly those with few treatment options
Diffuse pneumonitis from coronavirus HKU1 on checkpoint inhibitor therapy
No full textBackground Immune checkpoint inhibitors (ICIs) can produce specific immune-related adverse events including pneumonitis. The impact of ICI therapy on the severity of acute coronavirus infection symptomatology warrants further exploration.Case presentation We report a 65-year-old man diagnosed with stage IV melanoma who developed pulmonary and brain metastases and was treated with bilateral craniotomies followed by combined nivolumab and ipilimumab immunotherapy. He developed early-onset severe dyspnea associated with acute coronavirus HKU1 (non-COVID-19) infection, with diffuse pneumonitis evidenced by ground glass opacification on CT scan. He was treated with steroids leading to resolution of pneumonitis on repeat imaging, suggesting an exacerbated immune-mediated toxicity.Conclusion We report the first case of a patient with melanoma with severe and reversible diffuse pneumonitis in association with coronavirus HKU1 following combined nivolumab and ipilimumab immunotherapy. Although we do not have data on the impact of ICI therapy on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) symptomatology, a possible interaction should be considered when deciding on dosing in patients with possible SARS-CoV-2 exposure or when evaluating patients with presumed ICI-related pneumonitis during the COVID-19 pandemic
Forty-eight-Week Safety and Efficacy On-Treatment Analysis of Ibalizumab in Patients with Multi-Drug Resistant HIV-1
No full textAbstract
Background
Management of multi-drug-resistant (MDR) HIV-1 remains a challenge. The advent of antiretroviral (ARVs) with novel mechanisms of action are needed to expand therapeutic options for MDR patients. Ibalizumab (IBA) is a humanized monoclonal antibody with a unique binding specificity to the CD4 domain 2, allowing it to block viral entry into host cells without CD4 depletion. Patients completing the 24-week Phase 3 study (TMB-301) continued treatment in study TMB-311. Here, we report the durable efficacy and long-term safety of IBA with an optimized background regimen (OBR) through 48 weeks of treatment.
Methods
TMB-301 was an open-label study investigating the antiviral activity and safety of IBA plus OBR in highly treatment-experienced patients with MDR HIV-1. Patients received an intravenous loading dose of 2,000mg followed by 800mg doses every 2 weeks for 24 weeks. 7 days after loading dose, an OBR was added with at least 1 additional sensitive agent throughout the study. Following completion of the 24-week TMB-301 study, patients continued to receive IBA at 800mg every 2 weeks under TMB-311 for up to 48 weeks. Safety and efficacy were assessed until 48 weeks.
Results
A total of 31 patients enrolled in TMB-301 completed the 24-week treatment period. Of 31 patients, 27 entered study TMB-311. These patients were highly resistant patients - 59% and 33% of patients had exhausted ≥3 and ≥4 ARV classes, respectively, and 7% of patients had HIV-1 resistant to all approved ARVs. IBA plus OBR was well tolerated. Of the 27 patients, 24 (89%) continued to receive treatment until Week 48. The three patients discontinued early due to non IBA-related reasons. No new or unexpected safety concerns emerged between Week 24 and 48. The potent suppression of viremia observed Week 24 was sustained through Week 48. Median viral load (VL) reduction from BL was 2.5 log10 at both Week 24 and 48. Of 27 patients (59%) 16 had VL &lt;50 copies/ml and 17 (63%) patients had VL &lt; 200 copies/ml. All 15 patients with VL &lt; 50 copies/ml at Week 24 maintained viral suppression to Week 48.
Conclusion
IBA plus OBR continued to achieve high rates of virologic suppression through Week 48. The results support the durable efficacy and long-term safety of IBA in highly treatment-experienced MDR patients and offer a valuable treatment option for patients.
Disclosures
B. Emu, TaiMed Biologics: Employee and Shareholder, Salary; P. N. Kumar, TaiMed: Advisory Board and Investigator, Consulting fee and Grant recipient; G. Richmond, TaiMed: Investigator, Research support; S. Weinheimer, TaiMed: Employee, Salary; C. Marsolais, TaiMed: Commercial partner, Salary and Salary from Theratechnologies, commercial partner; S. Lewis, TaiMed: Employee, Salary and Salary from Theratechnologies, commercial partner
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Weight gain following switch to integrase inhibitors from non-nucleoside reverse transcriptase or protease inhibitors in people living with HIV in the United States: analyses of electronic medical records and prescription claims
No full textObjectives: Real-world data evaluating weight changes in people living with HIV (PLWH) following switch to integrase strand transfer inhibitor (INSTI), specifically bictegravir (BIC), are limited. This retrospective cohort study analyzed weight changes upon switching to INSTI from non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) in treatment-experienced PLWH. Methods: Adult PLWH (≥18 years) treated with NNRTI or PI (non-switch cohorts) and those switching to INSTI (switch cohorts) between 1JAN2014-31AUG2019 were identified using IQVIA’s Ambulatory Electronic Medical Records linked to prescription drug claims database. The associations of switching to INSTI and individual INSTI agents with having ≥5% weight gain at 12 months of follow-up were evaluated, adjusting for demographics and baseline clinical characteristics. Results: At 12 months of follow-up, PLWH in the NNRTI-INSTI switch cohort (n = 508) were more likely to have ≥5% weight gain over 12 months compared to the NNRTI non-switch cohort (n = 614; odds ratio, OR [95% CI], 1.7 [1.2-2.4]). Switching from NNRTI to dolutegravir (DTG: OR [95% CI], 2.1 [1.4-3.0]) or BIC (2.0 [1.0-4.2]) resulted in significantly higher odds of ≥5% weight gain. PI-INSTI switch (n = 295) and non-switch (n = 228) cohorts had similar proportion of PLWH with ≥5% (21.1%-23.4%) or ≥10% (7.8%-7.9%) weight gain, and no significant association was found between switching from PI to INSTI and weight gain. Conclusion: Weight gain and related metabolic health of PLWH switching from NNRTI to DTG or BIC should be closely monitored by clinicians. Further research is needed to assess other metabolic outcomes in PLWH remaining on PI and those who switch from PI to INSTI.</p
Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 phase iii trials.
No full textpeer reviewedBENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone
Legionnaires Disease With Focal Neurologic Deficits and a Reversible Lesion in the Splenium of the Corpus Callosum
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