Immunotherapy in transplanted patients: a special population that can no longer be ignored

Abstract Background Patients with chronic hemolytic anemias (CHA) are at a high risk for transfusion-transmitted infections. Various studies in Egypt have shown a prevalence of hepatitis C virus (HCV) infection in 24–37% of those patients. Elimination of hepatitis C virus (HCV) in patients with CHA would prevent early progression of liver disease. In this study, we aimed to assess the efficacy, safety, and tolerability of sofosbuvir (SOF) and daclatasvir (DAC) in the special population of HCV-infected patients with CHA. In this prospective study, 21 consenting hepatitis C patients were recruited and treated using ribavirin-free SOF/DAC regimen for either 12 or 24 weeks according to categorization of patients into easy or hard-to-treat in accordance with the national protocols. Sustained virological response was assessed by RT-PCR for HCV-RNA at 12 weeks post-treatment (SVR12). Any treatment-related adverse events were noted. Results All patients were adherent to treatment with no discontinuation of therapy. SVR12 was achieved in 19 out of 21 patients (90.5%). There was a significant improvement in levels of ALT (p<0.009) after completion of therapy. On the other hand, the hemoglobin, total bilirubin, and ferritin levels showed a non-significant difference (p<0.501, p<0.542, and p<0.339, respectively). Moderate adverse events were observed in 2 out of 21 patients (9.5%), including sickling crisis and hepatic decompensation. Conclusion The results of this study substantiate the favorable efficacy, safety, and tolerability of ribavirin-free direct-acting antivirals (DAAs) in the special population of HCV-infected patients with CHA. Micro-elimination of HCV in special patient populations allows for pragmatic delivery of care to patients with co-morbid conditions who are in most need for treatment and allows for achievement of global elimination of HCV worldwide.

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Meeting the educational needs of a gifted child: A parent’s narrative

Gifted Education International ◽

10.1177/0261429419863440 ◽

2019 ◽

Vol 35 (3) ◽

pp. 189-200

Author(s):

SA Manasawala ◽

DN Desai

Keyword(s):

Support Groups ◽

Educational Needs ◽

Education For All ◽

Gifted Children ◽

Local Learning ◽

Special Population ◽

Learning Resources ◽

Gifted Child ◽

Community Or

India is currently focusing on providing education for all, and special population like the gifted is being neglected. This is evident in the case of Aditya (IQ 145), a 7-year-old boy, and his parents who after discovering that their child is gifted attempt to meet his unique educational needs. Despite evidence of Aditya qualifying in examination two grades above his age level, the school authorities neither offer acceleration nor provide appropriate resources. This study attempts to delineate the importance of combined efforts of parent, school, and the community in nurturing gifted children. Finally, the researcher makes a few recommendations for parents: (i) create support groups to share parenting experiences; (ii) explore online and local learning resources to educate themselves about giftedness and nurture their children; and (iii) identify mentors in the community or other parents who can support in meeting the educational needs of these children.

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Chronic Cannabis Users: A New Special Population to Consider for Drug Development

Current Reviews in Clinical and Experimental Pharmacology ◽

10.2174/2772432816666210515145638 ◽

2021 ◽

Vol 16 ◽

Author(s):

Gina Pastino ◽

Diana Shuster

Keyword(s):

Clinical Pharmacology ◽

Drug Development ◽

Cannabis User ◽

Special Population ◽

Safety And Efficacy ◽

New Drug ◽

Metabolic Interactions ◽

Widespread Availability ◽

Baseline Characteristics ◽

Efficacy Profile

The use and acceptance of cannabis, either medically or recreationally, has substantially outpaced the collection of data necessary to evaluate its use in any population. However, the mere widespread availability does not imply the absence of risk or confirmation of efficacy and should not be treated as such. There is enough data to suggest that not only does the potential for pharmacokinetic and metabolic interactions exist, but also that baseline characteristics for a given population could be different in chronic cannabis users. Either or both of these may impact the safety and efficacy profile for any new drug in development. As such, we encourage drug developers to consider that the cannabis user may very well be a special population that warrants its own clinical pharmacology evaluation.

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Framework for the Design of Cannabis-Mediated Phase I Drug-Drug Interaction Studies

Current Reviews in Clinical and Experimental Pharmacology ◽

10.2174/2772432816666210813123716 ◽

2021 ◽

Vol 16 ◽

Author(s):

Diana L. Shuster ◽

Gina Pastino ◽

Dirk Cerneus

Keyword(s):

Drug Interaction ◽

Drug Development ◽

The United States ◽

The Body ◽

Cannabis User ◽

Special Population ◽

Care Providers ◽

Clinical Drug Development ◽

Drug Drug Interaction ◽

Clinical Drug

: Cannabis has become legal in much of the United States similarly to many other countries, for either recreational or medical use. The use of cannabis products is rapidly increasing while the body of knowledge of its myriad of effects still lags. In vitro and clinical data show that cannabis’ main constituents, delta-9-tetrahydrocannabinol and cannabidiol, can affect the pharmacokinetics (PK), safety and pharmacodynamics (PD) of other drugs. Within the context of clinical drug development, the widespread and frequent use of cannabis products has essentially created another special population; that is, the cannabis user. We propose that all clinical drug development programs include a Phase 1 study to assess the drug-drug interaction potential of cannabis as a precipitant on the PK, safety and if applicable, the PD of all new molecular entities (NMEs) in a combination of healthy adult subjects as well as frequent and infrequent cannabis users. This data should be required to inform drug labeling and aid health care providers in treating any patient, as cannabis has quickly become another common concomitant medication and cannabis users, a new special population.

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Understanding Graduate Student Parents: Influence of Parental Status, Gender, and Major on Graduate Students’ Motivation, Stress, and Satisfaction

Journal of College Student Retention Research Theory & Practice ◽

10.1177/15210251211072241 ◽

2022 ◽

pp. 152102512110722

Author(s):

Hyeon Jean Yoo ◽

David T. Marshall

Keyword(s):

Mental Health ◽

Graduate Students ◽

Graduate Student ◽

Female Students ◽

Multiple Roles ◽

Parental Status ◽

Special Population ◽

Stem Fields ◽

Student Parents ◽

And Gender

Graduate student parents are a unique subpopulation in higher education that accounts for a large proportion of graduate students. While student parents struggle to balance multiple roles, female students in STEM fields may face more significant barriers in balancing family and academic responsibilities compared to male graduate student parents or female students in non-STEM fields. Despite the urgent need to support this special population, little attention has been paid to how parental status, major, and gender affect graduate students. In this quantitative study of 545 graduate students, we examined the influence of parental status, major, and gender on motivation, stress, and satisfaction. A series of factorial ANOVAs found significant differences in motivation and mental health between graduate student parents and non-parents. Our findings highlight the importance of providing adequate resources to graduate students according to their status.

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