Drug company-sponsored patient assistance programs: a viable safety net?

Drug company-sponsored patient assistance programs (PAPs) provide access to brand-name medications at little or no cost and have been advocated as a safety net for inadequately insured patients. Yet little is known about these programs. We surveyed drug company-sponsored PAPs and found much variability in their structures and application processes. Most cover one or two drugs. Only 4 percent disclosed how many patients they had directly helped, and half would not disclose their income eligibility criteria. A better understanding of PAPs might clarify their role in improving access to medications, the adequacy of existing public programs, and their impact on cost-effective medication use.

Comparison of prospective and retrospective indicators of the quality of end-of-life cancer care.

PURPOSE: To compare prospectively and retrospectively defined benchmarks for the quality of end-of-life care, including a novel indicator for the use of opiate analgesia. METHODS: Linked claims and cancer registry data from 1994 to 2003 for New Jersey and Pennsylvania were used to examine prospective and retrospective benchmarks for seniors with breast, colorectal, lung, or prostate cancer who participated in state pharmaceutical benefit programs. RESULTS: Use of opiates, particularly long-acting opiates, was low in both the prospective and retrospective cohorts (9.1% and 10.1%, respectively), which supported the underuse of palliative care at the end-of-life. Although hospice was used more commonly in the retrospective versus prospective cohort, admission to hospice within 3 days of death was similar in both cohorts (28.8% v 26.4%), as was the rate of death in an acute care hospital. Retrospective and prospective measures identified similar physician and hospital patterns of end-of-life care. In multivariate models, a visit with an oncologist was positively associated with the use of chemotherapy, opiates, and hospice. Patients who were cared for by oncologists in small group practices were more likely to receive chemotherapy (retrospective only) and less likely to receive hospice (both) than those in large groups. Compared with patients who were cared for in teaching hospitals, those in other hospitals were more likely to receive chemotherapy (both) and to have toxicity (prospective) but were less likely to receive opiates (both) and hospice (retrospective). CONCLUSION: Retrospective and prospective measures, including a new measure of the use of opiate analgesia, identify some similar physician and hospital patterns of end-of-life care.

Neuropsychiatric changes in HIV/hepatitis C coinfected patients undergoing interferon therapy.

A large percentage of HIV-infected patients are coinfected with hepatitis C virus (HCV). Current treatment available for HCV combines interferon and ribavirin therapy for 6 months or longer. Interferon is associated with numerous neuropsychiatric side effects including depression, cognitive impairment, anxiety, and irritability. The potential for developing depression is particularly concerning with coinfection because the incidence of depression is higher in the HIV-seropositive population than in the general population. This article discusses the mechanism and prevalence of interferon-induced depression and the debate regarding appropriateness of treatment in certain segments of the HIV population. The role of antidepressants as both treatment and a prophylaxis against interferon-related depression is reviewed. Nurses have a critical role in the care of HIV/HCV coinfected patients who are undergoing treatment with interferon and ribavirin. They both assess for treatment readiness prior to initiation and provide close monitoring for the development of neuropsychiatric disturbances while on therapy.

Isolated antibody to hepatitis B core antigen in human immunodeficiency virus type-1-infected individuals.

We screened 651 human immunodeficiency virus (HIV)-1-infected subjects for hepatitis B surface antigen (HBsAg) and antibody to hepatitis B surface antigen (anti-HBs). Of a total of 387 subjects who tested negative for both HBsAg and anti-HBs, 142 underwent further testing for isolated presence of antibody to hepatitis B core antigen (anti-HBc). Of these 142 subjects, 60 (42%) tested positive for anti-HBc (isolated anti-HBc). Individuals coinfected with HIV-1 and hepatitis C virus (HCV) were more likely to have isolated anti-HBc than were subjects with HIV-1 alone (80% vs. 16%, respectively). Our findings suggest that individuals with HIV-1/HCV coinfection for whom there is no serological evidence for hepatitis B virus when screened with HBsAg and anti-HBs will be positive for anti-HBc in >75% of cases. A screening strategy that tests only for HBsAg and anti-HBs in HIV-1-infected patients will miss a large number of individuals with isolated anti-HBc.

Comparison of overlapping peptide sets for detection of antiviral CD8 and CD4 T cell responses.

Increasing efforts are directed towards the development of effective vaccines through induction of virus-specific T cell responses. Although emerging data indicate a significant role of these cells in determining viral set point in infections such as HIV, there is as yet no consensus as to the best methods for assaying the breadth of these responses. In this study, we used sensitive interferon gamma-based intracellular cytokine staining (ICS) and Elispot assays to determine the optimal overlapping peptide set to screen for these responses. Twenty persons with established HIV infection were studied, focusing on responses to the highly immunogenic Nef protein. Six different HIV-1 Nef peptide sets were used, ranging in length from 15 to 20 amino acids (aa), in overlap from 10 to 11 amino acids, and derived from two different B clade sequences. A total of 54 CD8 T cell responses to Nef peptides were found in this cohort, of which only 12 were detected using previously defined Nef optimal epitopes. No single peptide set detected all responses. Though there was a trend of the shorter peptides detecting more CD8 T cell responses than the 20 amino acid long peptides and longer peptides detecting more CD4 T cell responses, neither was statistically significant. There was no difference between an overlap of 10 or 11 amino acids. All responses detected with the six different sets of overlapping peptides were towards the more highly conserved regions of Nef. We conclude that peptides ranging from 15 to 20 amino acids yield similar results in IFN-gamma-based Elispot and ICS assays, and that all are likely to underestimate the true breadth of responses to a given reference strain of virus.

Antiretroviral drug resistance mutations in antiretroviral-naive prisoners.

We assessed the incidence of antiretroviral drug resistance in a cohort of 25 antiretroviral-naive, human immunodeficiency virus-positive inmates in Massachusetts. Silent mutations, unexpected mutations at resistant sites, and resistance mutations were recorded. Among these inmates, we found a prevalence of drug resistance mutations that was equivalent to the prevalence previously found in nonprison populations in the same state.