Pharmacology
Nivolumab Approved for Expanded Indication
Nivolumab is now approved to treat metastatic squamous non-small cell lung cancer, although adverse effects such as serious immune-mediated...
Dr. Winn is a clinical psychologist, Dr. Francis is an attending psychiatrist, Dr. Shealy is a clinical psychologist, Ms. Paton is a retired licensed practical nurse, Ms. Planner is a retired registered nurse, Ms. Kelly is a retired registered nurse, and Dr. Gonzales-Nolas is an attending psychiatrist, all at the James A. Haley Veterans’ Hospital in Tampa, Florida. Ms. Levarge is an advanced registered nurse practitioner at American Lake Division of the VA Puget Sound Healthcare System in Lakewood, Washington. Dr. Winn is an assistant professor, Dr. Francis is an associate professor, Dr. Shealy is an assistant professor, and Dr. Gonzales-Nolas is an assistant professor, all at the University of South Florida in Tampa.
A recent study showed that there is a positive relationship between the amount of hepatitis counseling received and knowledge of hepatitis.25 Possibly, increased intensity of education efforts may make an impact on initiation rates. Encouragingly, there is also evidence that prompting people to predict their future vaccination behavior may increase vaccination initiation rates despite a high-degree of short-term barriers, such as perceived pain or inconvenience.26 A brief intervention to induce people to formulate their future intentions would be relatively easy to incorporate into a vaccination program, and the study team is considering options for this to improve vaccination initiation rates.
Patients can expect to achieve substantial immunity from hepatitis A and, to a lesser degree, hepatitis B after completing the first 3 injections of the series, although the best seroprotection from both is obtained by completing the 12-month booster injection as well.17 Overall, about half of all patients who completed the first 3 injections returned for the booster shot, but only 35% of the patients with hepatitis C did so. The most common known cause of any patient not receiving the booster was movement out of the geographic area. However, much of the time the investigators were unable to determine the reasons patients did not return for the booster shot.
Medication adherence is a difficult problem with vaccination in high-risk samples, although Stitzer and colleagues found a significant improvement in follow-up for a 6-month vaccination protocol by using monetary incentives.27 In addition to ensuring medication adherence, it would also be of value for future immunization efforts to include testing to assess whether seroconversion has occurred once the vaccinations are complete, which is the ultimate measure of the success of a vaccination program. Most patients in the current study did not receive such testing at the completion of their vaccination schedules, and thus, seroconversion rates could not be determined. However, existing studies suggest high rates of seroprotection after the first 3 doses of the combined vaccine.10,17
The retrospective nature of the study is its most significant limitation. Any conclusions about the results must be made with caution. However, this design allowed for a naturalistic and potentially generalizable investigation into the application of a vaccination program in a real-world treatment setting. As such, the investigators were able to demonstrate the feasibility of conducting a rapid vaccination program within a 3- to 6-week SATP.
The retrospective nature of the study also limited a full investigation into the reasons behind the lack of vaccination initiation and vaccination noncompletion among the study’s treatment population, especially with regard to the follow-up booster injection. Initial statistical comparisons of initiators and noninitiators and completers and noncompleters showed no significant statistical differences between the groups. Future prospective designs should take into account the need to successfully initiate and complete vaccinations for all eligible patients and include assessment measures to determine the specific reasons that patients did not initiate or complete their vaccinations.
Many patients began and completed the accelerated vaccination schedule for hepatitis A and B in the context of a 3- to 6-week SATP at JAHVH. The overall vaccination rate, including the 12-month booster injection, was one-fifth of the entire vaccination-eligible sample. Additionally, 88% of the vaccination-eligible patients who began the vaccination schedule (or 42% of the whole sample) completed at least the first 3 doses, which may confer substantial immunity from hepatitis A and B. For reasons not entirely clear, a little less than half the vaccination-eligible patients began the vaccination schedule, and only about 50% of those returned to receive their 12-month booster injection. Future prospective studies may be able to determine barriers to both the initiation of and adherence to the vaccination protocol.
The results of this study are also a testament to having primary care nursing staff available and actively involved in the care of patients in a SATP. It seems likely that additional interventions might be needed for outreach to and retention of patients in need of vaccination for hepatitis A and B, and particularly those patients with hepatitis C. It is important to find ways to increase the rates of 12-month booster vaccinations, both for veterans who continue to receive services at JAHVH and for those who transfer care to other VA facilities. Finally, testing to confirm serologic immunity to hepatitis A and hepatitis B would be the next step in the effort to eliminate the risk of hepatitis A and hepatitis B and minimize additional harm for those with hepatitis C in the population receiving treatment for addictive disorders.
Nivolumab is now approved to treat metastatic squamous non-small cell lung cancer, although adverse effects such as serious immune-mediated...