scholarly journals 1003. BIC/FTC/TAF Maintains Viral Suppression in Patients with Documented M184V/I Mutations: A Real World Experience

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S530-S530
Author(s):  
Nicholas Chamberlain ◽  
James B Brock ◽  
Leandro A Mena
Keyword(s):  
Real World ◽  
Viral Suppression ◽  
Group Analysis ◽  
Case Series ◽  
Common Mutation ◽  
Research Support ◽  
Adherence To Medication ◽  
Sustained Viral Suppression ◽  
Real World Setting ◽  
Level Resistance

Abstract Background The M184V/I mutation is a common mutation in treatment-experienced patients with HIV and confers high-level resistance to lamivudine and emtricitabine. Our objective is to assess the effectiveness of bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) in a real-world setting in achieving and maintaining viral suppression in patients with documented M184V/I mutations. Methods This case series is comprised of treatment-experienced HIV-positive patients with documented historical or newly-identified M184V/I mutations who were placed on BIC/FTC/TAF as a switch strategy or as therapy for patients who had failed a prior regimen. Patients with any resistance to tenofovir or bictegravir were excluded. Our primary outcome was sustained viral suppression at 12 months after initiation of BIC/FTC/TAF. Results We included 33 patients (94% black, 52% male, median age 49, range 36-63) with an M184V/I mutation. The majority (91%) showed sustained viral suppression at 12 months of treatment. Non-adherence to medication was the common factor in all three cases of treatment failure. One patient developed an R263K mutation while on therapy, which conferred low-level resistance to bictegravir. There were no other instances of newly-acquired resistance to any of the components of BIC/FTC/TAF. Conclusion Our results demonstrate high success rates of BIC/FTC/ATF in achieving and maintaining viral suppression in patients with documented M184V/I mutations who adhere to medications in a real-world setting with a single instance of new treatment-emergent resistance to bictegravir. These findings are congruent with reported sub-group analysis in clinical trial data and support the use of BIC/FTC/TAF in patients with M184V/I mutations. Disclosures Leandro A. Mena, MD, MPH, Binx Health (Grant/Research Support)Evofem (Grant/Research Support)Gilead Science (Consultant, Grant/Research Support, Speaker’s Bureau)GSK (Grant/Research Support)Janssen (Grant/Research Support)Merck (Consultant, Grant/Research Support)Roche Molecular (Consultant, Grant/Research Support)SpeedDx (Grant/Research Support)ViiV Healthcare (Consultant, Grant/Research Support, Speaker’s Bureau)

A Direct Aspiration First Pass Technique in Japanese Real-World Clinical Setting

2018 ◽  
Vol 17 (2) ◽  
pp. 115-122 ◽  
Author(s):  
Junji Uno ◽  
Katsuharu Kameda ◽  
Ryosuke Otsuji ◽  
Nice Ren ◽  
Shintaro Nagaoka ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Real World ◽  
Cerebral Blood Volume ◽  
Mechanical Thrombectomy ◽  
Case Series ◽  
Entire Study ◽  
Stroke Treatment ◽  
Real World Setting ◽  
Hemorrhagic Complications ◽  
First Pass

Abstract BACKGROUND It is debatable whether mechanical thrombectomy has benefits in a real-world setting outside the more rigid and selective clinical trial environment. OBJECTIVE To evaluate clinical outcomes, efficacy, and safety of mechanical thrombectomy in single-center retrospective cohort case series. METHODS We reviewed prospectively collected data from our large-vessel occlusion stroke database to identify patients undergoing mechanical thrombectomy using Penumbra catheters (Penumbra, Almeida, California) as first-line devices. The primary outcomes were the modified Rankin Scale score at 90 d and recanalization rate. The secondary outcomes included the rates of hemorrhagic complications and mortality. RESULTS The entire study population included 298 patients. Thrombolysis in Cerebral Infarction Scale ≥2b was achieved in 86.6% of patients. Fifty-five patients (18.5%) were outside the 6 hr time window and 82 patients (27.5%) were over 80-yr old. The posterior circulation thrombectomy rate was 12.4%. At 90 d from onset, 49.3% of patients had favorable outcomes. The parenchymal hemorrhage type 2 (PH2) and subarachnoid hemorrhage rates were 2.3% and 11.7%, respectively. In multivariate analyses, cerebral blood flow/cerebral blood volume mismatch (odds ratio [OR] = 9.418; 95% confidence interval [CI], 3.680-27.726; P < .0001), onset to recanalization time (OR = 0.995; 95% CI, 0.991-0.998; P = .0003), and hemorrhagic complications including PH2 and subarachnoid hemorrhage (OR = 0.186; 95% CI, 0.070-0.455; P = .0002) were associated with favorable outcomes. CONCLUSION A direct aspiration first pass technique with an adjunctive device demonstrated high recanalization rates in old Japanese patients. Our patient cohort may reflect the application of endovascular techniques in acute ischemic stroke treatment in a real-world setting.

scholarly journals Early Outcomes of a Synthetic Cartilage Implant for Treatment of Hallux Rigidus: A Series of 87 Patients

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0015
Author(s):  
Michael A. Campbell
Keyword(s):  
Real World ◽  
Case Series ◽  
Hallux Rigidus ◽  
Time Interval ◽  
Pivotal Trial ◽  
Human Cartilage ◽  
First Metatarsophalangeal Joint ◽  
Real World Setting ◽  
Positive Results

Category: Midfoot/Forefoot; Bunion Introduction/Purpose: Arthritis of the first metatarsophalangeal joint (MTPJ), or hallux rigidus, is the most common arthritic condition of the foot, affecting 1 in 40 people over 50 years of age. One surgical option is the implantation of a synthetic polyvinyl alcohol hydrogel implant that has water content, tensile strength, and biomechanical properties similar to those of healthy human cartilage. This implant is supported by positive outcomes in a Level 1 clinical trial out to over 5 years follow-up. The objective of this case series was to determine if the positive results seen in the pivotal trial could be recreated in a ‘real world’ setting. Methods: All patients implanted with a synthetic cartilage implant by a single surgeon between September 2016 and December 2018 were retrospectively reviewed. Consecutive adult patients diagnosed with hallux rigidus that failed nonoperative treatment were included in the analysis. Patient demographics, complications, Foot and Ankle Ability Measures (FAAM), and a 10-point visual analog score (VAS) were collected from the chart review. Results: A total of 87 patients were available for review during the time interval of interest with a mean length of follow-up of 38.7 weeks (range, 2-125). The average patient age was 56.6 years (range, 21-80). Two (2.3%) patients were converted to fusion. The first at 71 weeks and the second at 73 weeks following the initial surgery. Six (6.9%) patients experienced some complications: 3 cases of synovitis treated with corticosteroid injection; 1 case of sesamoiditis; 1 case of neuritis; and 1 insufficiency fracture at the plantar aspect of the MTPJ with implant subsidence. Patients had mean FAAM ADL and VAS scores of 81.2 (range 21-100) and 0.6 (range, 0-3), respectively, at final follow-up. Conclusion: This retrospective review is one of the first presentations of outcomes for a synthetic cartilage implant in a ‘real world’ setting. Patients experienced excellent pain relief, good functional outcomes, and a satisfactory survival rate. This case series confirms the positive results seen in the original pivotal trial for this device.

scholarly journals POS0296 DOSING OF BDMARDS IN AXSPA AND PSA IN A REAL WORLD SETTING

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 373.1-373
Author(s):  
A. Regierer ◽  
A. Weiß ◽  
D. Poddubnyy ◽  
H. Kellner ◽  
F. Behrens ◽  
...  
Keyword(s):  
Real World ◽  
Standard Dose ◽  
Research Support ◽  
Biologic Dmards ◽  
Real World Setting ◽  
The Mean ◽  
Receive Treatment ◽  
Prospective Longitudinal ◽  
Higher Doses

Background:The treatment of patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) has been revolutionised by the introduction of biologic DMARDs targeting TNF, IL17, and IL23 inhibitors (i). In Germany, about 30-50% of axSpA and PsA patients receive treatment with bDMARDs. Although many patients benefit from these drugs, in some patients effectiveness of the standard dose may be insufficient and higher doses are used.Objectives:To describe dosing of TNFi and non-TNFi bDMARDs over a 2 year period in a real world cohort of patients with axSpA and PsA managed by rheumatologists.Methods:RABBIT-SpA is a prospective longitudinal cohort study including axSpA and PsA patients enrolled at the start of a new conventional treatment (including NSAID) or b/tsDMARD treatment. Description of dosing of TNFi (adalimumab bio-original (bo), adalimumab bio-similar (bs), etanercept bo, etanercept bs, golimumab, certolizumab) in comparison to nonTNFi-bDMARDs (secukinumab, ustekinumab, ixekizumab, guselkumab) in axSpA and PsA. Standard dosing was defined according to the current labels for axSpA and PsA.Results:1628 patients (axSpA: n=903, PsA: n=725) were included in this analysis. At inclusion mean age was 44 years in axSpA and 51 years in PsA. 44% of patients with axSpA and 58% of those with PsA were female. The mean disease duration of axSpA was 7.6 years, of PsA 6.4 years.Standard doses of TNFi were used during a 2 year period in > 90% of patients with axSpA and PsA (Figure 1). In contrast, standard doses of non-TNFi-bDMARDs were only used in 70-80% of patients. The percentage of documented higher doses in patients with axSpA ranged from 20-30% at different time points. In PsA, this percentage increased from 27% at baseline to 44% at 2 years. On the other hand, TNFi were used in lower doses than the label in up to 9% and 7 % of patients with axSpA and PsA, respectively, after 2 years.Figure 1.Percentages of patients with axSpA or PsA who received less than, equal to, or more than the approved doses of bDMARDs at baseline and at 5 follow-up visits.Conclusion:While TNFi are used in licensed doses in most patients, non-TNFi-bDMARDs were often used in higher doses, which corresponds to higher doses approved in other indications like psoriasis. The effectiveness of this treatment strategy in axSpA and PsA needs to be analysed further.Acknowledgements:RABBIT-SpA is supported by a joint, unconditional grant from AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris.We thank all participating patients and rheumatologists.Disclosure of Interests:Anne Regierer Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris., Anja Weiß Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris., Denis Poddubnyy: None declared, Herbert Kellner: None declared, Frank Behrens: None declared, Georg Schett: None declared, Juergen Braun: None declared, Joachim Sieper: None declared, Anja Strangfeld Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris

scholarly journals Clinical observations of acute onset of myopic optic neuropathy in a real-world setting

2021 ◽  
Vol 14 (3) ◽  
pp. 461-467
Author(s):  
Li Liao ◽  
◽  
Fang Fang ◽  
Xiao-Hua Zhu ◽  
◽  
...  
Keyword(s):  
Clinical Features ◽  
Optic Neuropathy ◽  
Real World ◽  
Vision Loss ◽  
Case Series ◽  
Acute Onset ◽  
Glucocorticoid Therapy ◽  
Glucocorticoid Treatment ◽  
Real World Setting ◽  
Systemic Glucocorticoid

AIM: To describe the clinical features of acute myopic onset of optic neuropathy and observe the effects of retrobulbar and systemic glucocorticoid therapy in a real-world setting. METHODS: A retrospective observational case series included 18 patients with a clinical diagnosis of acute onset of myopic optic neuropathy in a real-world setting. While the patients were using retrobulbar and systemic glucocorticoid therapy, various imaging examination data were analysed, and the clinical features of myopic optic neuropathy were summarized for 6mo to 2y. RESULTS: The included group of patients with acute onset of myopic optic neuropathy consisted mostly of females (n=11). The visual field (VF) showed abnormalities in bilateral eyes, including the spread of physiological blind spots, central and paracentral dark spots, and centripetal peripheral VF reduction; but central vision with no subjective changes. The visual evoked potential (VEP) was abnormal in all eyes with vision loss. The best corrected visual acuity (BCVA) was improved from 1.04±0.63 to 0.47±0.57 (logMAR) after glucocorticoid treatment (P<0.05). In patients with a short course (within 1wk), recovery was fast and achieved the same BCVA as recorded before the onset within 6d. However, in patients with the long course (1 to 2wk), recovery was slow and did not achieve the BCVA recorded before the onset within 10d. The changes of intraocular pressure (IOP) were not obvious before and after treatment (18.68±5.30 vs 19.55±5.34 mm Hg, P>0.05). There was no recurrence during long-term follow-up observation. CONCLUSION: The acute onset of myopic optic neuropathy is characterized by BCVA and VF abnormalities in bilateral eyes. Retrobulbar and systemic glucocorticoid therapy is effective.

scholarly journals Surgical aspects of thoracic aortic aneurysms: A case series from a real-world setting

2021 ◽  
pp. 103099
Author(s):  
Aniss Seghrouchni ◽  
Noureddine Atmani ◽  
Younes Moutakiallah ◽  
Youssef El Bekkali ◽  
Mahdi Ait Houssa
Keyword(s):  
Real World ◽  
Case Series ◽  
Aortic Aneurysms ◽  
Thoracic Aortic Aneurysms ◽  
Real World Setting ◽  
Surgical Aspects

Safety and efficacy of nivolumab in older patients (pts) with renal cell carcinoma: Results of a sub-group analysis of the GETUG-AFU 26 NIVOREN multicenter phase II study.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 331-331
Author(s):  
Loic Mourey ◽  
Cécile Dalban ◽  
Sylvie Negrier ◽  
Christine Chevreau ◽  
Gwenaelle Gravis ◽  
...  
Keyword(s):  
Real World ◽  
Older Patients ◽  
Kinase Inhibitors ◽  
Group Analysis ◽  
Age Groups ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Primary Objective ◽  
Safety And Efficacy ◽  
Real World Setting

331 Background: NIVOREN GETUG AFU 26 study, is a french multicenter prospective study to evaluate safety and efficacy of Nivolumab (N) in a broad “real world setting” in mRCC after failure of 1 or 2 tyrosine kinase inhibitors. Methods: Between February 2016 and July 2017, 729 pts were enrolled across 27 institutions. Primary objective of the trial was safety assessed by grade ≥ 3 treatment related adverse event (TRAE). We report here results of older patients above 70 years old ([70;75[; [75;80[; ≥ 80) compared with their younger counterparts. Results: Overall, 720 patients were treated (median age 64 (22;90)). Among them 205 pts were ≥ 70 (28.5%) divided as follow: [70-75[:107 (14.9%) / [75-80[: 68 (9,4%) / ≥ 80: 30 (4,2%). Patients’ characteristics (Table) were similar in younger and older patients except for IMDC risk groups (IMDC) classification with less poor prognostic in pts ≥ 75 and fewer brain metastasis in pts ≥ 70. Treatment duration was similar across age groups despite a rate of discontinuation for TRAE increasing with age. Regarding efficacy, there was a non-significant trend toward improved response rate and progression free survival and lower specific survival with increasing age. Conclusions: In this large “real world” setting study a significant number of old pts were included. Prognostic profile appears better in older pts included. There is no signal for an excess of toxicity in this population and efficacy is comparable to younger patients. Age alone should not prevent prescribing N in mRCC. Clinical trial information: NCT03013335 . [Table: see text]

Sustained viral suppression with co-administration of oxcarbazepine and dolutegravir

2018 ◽  
Vol 29 (8) ◽  
pp. 831-833 ◽  
Author(s):  
Manar M Kandil ◽  
Melissa E Badowski ◽  
Christopher A Schriever
Keyword(s):  
Antiretroviral Therapy ◽  
Viral Suppression ◽  
Case Series ◽  
Concomitant Administration ◽  
Additional Patient ◽  
Virologic Suppression ◽  
Insufficient Data ◽  
Sustained Viral Suppression ◽  
Immunodeficiency Virus ◽  
High Doses

Co-administration of dolutegravir and oxcarbazepine has been reported to reduce levels of dolutegravir and therefore is contraindicated due to insufficient data to make dosing recommendations. We present eight cases in which patients with human immunodeficiency virus (HIV) inadvertently received oxcarbazepine while concurrently receiving 50 mg of dolutegravir daily as part of their antiretroviral therapy. Upon further evaluation, lab results revealed that despite the risk of decreased levels of dolutegravir due to possible oxcarbazepine enzyme induction, patients maintained at or near virologic suppression (viral load <20 copies/ml). Suppression was maintained in patients virally suppressed prior to oxcarbazepine initiation as well as in patients receiving high doses of oxcarbazepine (>1200 mg). All patients self-reported complete adherence to oxcarbazepine and dolutegravir. Furthermore, careful review of additional patient medications suggested no other identifiable drug interactions that could have affected their antiretroviral therapy. This case series suggests that despite the well-documented drug interaction, concomitant administration of oxcarbazepine and dolutegravir in the clinical setting did not adversely affect viral suppression in patients with HIV.

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