TABLE 1.
Barriers and challenges to oncolytic virus clinical implementation.
| Challenge to OV implementation | Comments |
|---|---|
| Requires storage at −80°C | • Many pharmacies do not have deep freezer capabilities |
| Live virus must be prepared in sterile biosafety cabinet | • Dedicated preparation space is often difficult in pharmacies preparing chemotherapy and other agents |
| • Contamination of other drug products requires strict SOPs and dedicated time, space, and training for pharmacists | |
| Drug dosing is different for initial injection vs. later timepoints | • Two different doses must be maintained and prepared appropriately |
| Drug volume is dependent on maximal tumor diameter | • Volume cannot be determined until the patient has tumor measured resulting in ordering delays and longer patient treatment wait times |
| • May require new ordering forms/processes | |
| Injection requires direct access to tumor site and manual administration | • Lesions may not be palpable or may regress to a size that is not detectable |
| • Bedside ultrasound can help guide injections and may be used when lesion regress below levels of clinical detection | |
| • Technical training is required for optimal delivery | |
| • May be administered by non-physicians, such as nurse practitioners or physician assistants | |
| Biosafety concerns | • OV are typically live, replicating viruses and clinics must adopt biosafety measures for spills and waste |
| • Usually only requires standard universal precautions | |
| Household and healthcare transmission | • Virus can be transmitted to close contacts |
| • Acyclovir and other anti-virals which may be used in cases of inadvertent exposure | |
| • Transmission can be prevented by barrier bandages and educating patients to avoid direct contact between injection site and other individuals | |
| • Training for healthcare providers, affiliated clinic staff, patients and patient families may help prevent accidental spread | |
| May require change to ambulatory practice | • Can improve process by dedicating specific room(s) and clinic day(s) for OV injection |
| • Healthcare centers may require written SOPs and approval by biosafety and/or infection control committees | |
| • Practice deviations may be difficult if only a limited number of patients are treated with OV therapy at site |