Gene therapy: a possible future standard for HIV care

Abou‐El‐Enein, Mohamed; Bauer, Gerhard; Reinke, Petra

doi:10.1016/j.tibtech.2015.03.006

Cited by 8 publications

(5 citation statements)

References 17 publications

(18 reference statements)

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“…This risk also extends to healthcare providers and individuals accidentally exposed to the virus during preparation or product administration or those in close contact to treated patients. Therefore, a holistic approach to education, awareness, and support is needed for patients, their families, and their physicians to address potential benefits as well as possible risks associated with the therapeutic administration (Abou-El-Enein et al, 2015). Effective public outreach programs are required to identify the target audience and inform them of the potential risks associated with such therapies.…”

Section: Potential Risks Associated With Administration Of Gene Therapiesmentioning

confidence: 99%

Overcoming Challenges Facing Advanced Therapies in the EU Market

2016

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Section: Potential Risks Associated With Administration Of Gene Therapiesmentioning

confidence: 99%

Overcoming Challenges Facing Advanced Therapies in the EU Market

2016

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“…Multiple scientific, ethical, legal, and social issues impact the responsible translation of stem cells and regenerative medicine ( Abou-El-Enein et al., 2015 , 2014 ; Bauer et al., 2018 ). A WHO EAC on Regenerative Medicine could address several issues, including standardization of regulatory definitions and practices; the need for robust scientific data on the safety and efficacy of cell-based therapies balanced with patients' unmet medical needs; adequate protection of participants in first-in-human regenerative therapy trials; and informing patients and clinicians in an area of substantial misinformation ( Chan, 2017 ; Lee et al., 2017 ; MacPherson and Kimmelman, 2019 ; Richardson et al., 2020 ; Sipp et al., 2017 ).…”

Section: Main Textmentioning

confidence: 99%

Unproven stem cell interventions: A global public health problem requiring global deliberation

2021

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“…In one publication, the potential irresponsible use of novel technologies and unrealistic expectation of cure (eg, in the case of HIV) were also noted as a barrier related to patients' perception. 8 Furthermore, the fear that genetic therapy will be used by those with means to improve intellect, physical abilities and longevity, thereby enhancing social inequality was also noted as a potential access barrier. 11 35 Additionally, patients may be unwilling to receive genetic therapy due to psychological challenges (eg, receiving news about testing positive for a genetic marker of disease).…”

Section: Patients' Perceptionmentioning

confidence: 99%

“…These differences lead to different comparisons and conclusions on gene therapy reimbursement, which may cause discrepancies in patient access. 8…”

Section: Socioeconomical Factorsmentioning

confidence: 99%

Patient access to gene therapy medicinal products: a comprehensive review

2020

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BackgroundGene therapies have the potential to be a curative approach to a large number of genetic diseases. However, granting of a positive marketing authorisation does not equal patient access to therapy.ObjectivesThe purpose of this paper is to identify a full set of hurdles potentially preventing patient access to gene therapies based on the available literature.MethodsA review of the literature using systematic approach in two distinct databases was performed by identifying relevant, peer-reviewed publications, between 2012 and 2018.ResultsSeven major topics were identified as potential patient access hurdles, namely affordability, assessment of value, development of therapy, ethical/social factors, evidence generation, operational implementation and regulatory hurdles. From these, 25 additional subthemes were further identified. The most frequently mentioned obstacle in the literature is related to the affordability aspect especially focusing on high cost of therapy (84%) and therapy payment/reimbursement (51%). Importantly, the evidence generation focusing on limited trial outcomes (81%) seems as a strong obstacle in patient access to these therapies.ConclusionsA growing number of gene therapies are expected to be developed and made available to patients and healthcare professionals. Improvement of patient access to gene therapies can only be achieved by understanding all hurdles, in a complete and integrated fashion, so that strategies are timely established to ensure gene therapies’ benefits are provided to patients and to the society.

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Gene therapy: a possible future standard for HIV care

Cited by 8 publications

References 17 publications

Overcoming Challenges Facing Advanced Therapies in the EU Market

Overcoming Challenges Facing Advanced Therapies in the EU Market

Unproven stem cell interventions: A global public health problem requiring global deliberation

Patient access to gene therapy medicinal products: a comprehensive review

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