John F. Toney

Recombinant Human Erythropoietin in the Treatment of Anemia Associated with Human Immunodeficiency Virus (HIV) Infection and Zidovudine Therapy: Overview of Four Clinical Trials

OBJECTIVE To assess the effect of recombinant human erythropoietin (r-HuEPO) on anemia in patients with the acquired immunodeficiency syndrome (AIDS) who are receiving zidovudine therapy. DESIGN Combined analysis of four 12-week, randomized, double-blind, controlled clinical trials. SETTING Multiple centers in the United States. PATIENTS Two hundred and ninety-seven anemic (hematocrit < 30%) patients with AIDS who were receiving zidovudine therapy. Of the 297 patients, 255 were evaluable for efficacy, but all patients were included in analysis of safety. INTERVENTION Patients were randomly assigned to receive either r-HuEPO (100 to 200 U/kg body weight) or placebo, intravenously or subcutaneously, three times per week for up to 12 weeks. MEASUREMENTS Changes in mean hematocrit, transfusion requirement, and quality of life. RESULTS Sixty-nine percent of patients had endogenous serum erythropoietin levels less than or equal to 500 IU/L, and 31% had erythropoietin levels greater than 500 IU/L. In patients with low erythropoietin levels (< or equal to 500 IU/l), r-HuEPO therapy decreased the mean number of units of blood transfused per patient when compared with placebo (3.2 units and 5.3 units, respectively; P = 0.003) and increased the mean hematocrit from the baseline level (4.6 percentage points and 0.5 percentage points, respectively; P <0.001). Overall quality of life improved in patients on r-HuEPO therapy (P = 0.13). Patients with erythropoietin levels greater than 500 IU/L showed no benefit from r-HuEPO in any outcome variable. Placebo and r-HuEPO recipients did not differ in the incidence of adverse effects or opportunistic infections. CONCLUSION Therapy with r-HuEPO can increase the mean hematocrit and decrease the mean transfusion requirement in anemic patients with AIDS who are receiving zidovudine and have endogenous low erythropoietin levels (< or equal to 500 IU/L). Such therapy is of no apparent benefit in patients whose endogenous erythropoietin levels are higher than 500 IU/L.

Persistence of the Efficacy of Zoster Vaccine in the Shingles Prevention Study and the Short-Term Persistence Substudy

BACKGROUND The Shingles Prevention Study (SPS; Department of Veterans Affairs Cooperative Study 403) demonstrated that zoster vaccine was efficacious through 4 years after vaccination. The Short-Term Persistence Substudy (STPS) was initiated after the SPS to further assess the persistence of vaccine efficacy. METHODS The STPS re-enrolled 7320 vaccine and 6950 placebo recipients from the 38 546-subject SPS population. Methods of surveillance, case determination, and follow-up were analogous to those in the SPS. Vaccine efficacy for herpes zoster (HZ) burden of illness, incidence of postherpetic neuralgia (PHN), and incidence of HZ were assessed for the STPS population, for the combined SPS and STPS populations, and for each year through year 7 after vaccination. RESULTS In the STPS as compared to the SPS, vaccine efficacy for HZ burden of illness decreased from 61.1% to 50.1%, vaccine efficacy for the incidence of PHN decreased from 66.5% to 60.1%, and vaccine efficacy for the incidence of HZ decreased from 51.3% to 39.6%, although the differences were not statistically significant. Analysis of vaccine efficacy in each year after vaccination for all 3 outcomes showed a decrease in vaccine efficacy after year 1, with a further decline thereafter. Vaccine efficacy was statistically significant for the incidence of HZ and the HZ burden of illness through year 5. CONCLUSIONS Vaccine efficacy for each study outcome was lower in the STPS than in the SPS. There is evidence of the persistence of vaccine efficacy through year 5 after vaccination but, vaccine efficacy is uncertain beyond that point.

Long-Term Persistence of Zoster Vaccine Efficacy

BACKGROUND The Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination. METHODS Surveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups. RESULTS The LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8. CONCLUSIONS Estimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8.

Epithelioid angiomatosis secondary to disseminated cat scratch disease involving the bone marrow and skin in a patient with acquired immune deficiency syndrome: A case report

A ngiomatous lesions, distinct from Kaposi’s sarcoma, have been reported in patients with acquired immunodeficiency syndrome (AIDS) since 1983 [l]. Infection with cat scratch bacillus may be responsible for some of these lesions [2-41. A patient with AIDS and biopsy-proven cat scratch disease in the skin and bone marrow, with indirect evidence of liver and spleen involvement, is presented. Bone marrow specimens showed diffuse bacterial infiltration without an osteolytic reaction.

Safety of Zoster Vaccine in Elderly Adults Following Documented Herpes Zoster

BACKGROUND After completion of the Shingles Prevention Study (SPS; Department of Veterans Affairs Cooperative Studies Program Number 403), SPS participants who had initially received placebo were offered investigational zoster vaccine without charge. This provided an opportunity to determine the relative safety of zoster vaccine in older adults following documented herpes zoster (HZ). METHODS A total of 13 681 SPS placebo recipients who elected to receive zoster vaccine were followed for serious adverse events (SAE) for 28 days after vaccination. In contrast to the SPS, a prior episode of HZ was not a contraindication to receiving zoster vaccine. The SPS placebo recipients who received zoster vaccine included 420 who had developed documented HZ during the SPS. RESULTS The mean interval between the onset of HZ and the receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median interval, 3.77 years [range, 3-85 months]); the interval was <5 years for approximately 80% of recipients. The proportion of vaccinated SPS placebo recipients with prior HZ who developed ≥ 1 SAE (0.95%) was not significantly different from that of vaccinated SPS placebo recipients with no prior history of HZ (0.66%), and the distribution of SAEs in the 2 groups was comparable. CONCLUSIONS These results demonstrate that the general safety of zoster vaccine in older persons is not altered by a recent history of documented HZ, supporting the safety aspect of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommendation to administer zoster vaccine to all persons ≥ 60 years of age with no contraindications, regardless of a prior history of HZ.

INFECTION VERSUS COLONIZATION IN THE CRITICAL CARE UNIT

Serious infections in the critical care unit are commonplace. However, distinguishing true infection from mere colonization is a difficult and often uncertain process that has been shown to result in both over- and under-treatment of patients. Antimicrobial agents used in the CCU setting are expensive and not without toxicities. This article discusses methods to differentiate colonization from infection.

NEW PERSPECTIVES ON THE MANAGEMENT OF SEPTIC SHOCK IN THE CANCER PATIENT

Septic shock is a common life-threatening problem, usually presenting with fever, tachycardia, tachypnea, and often a source of infection. The cardiac index is increased, with a decreased systemic vascular resistance, and a reversibly decreased ejection fraction with an increased end diastolic volume. The myocardial depression is most likely caused by a circulating humoral substance that depresses myocardial contractility. The initial treatment of septic shock is aggressive fluid resuscitation and antibiotic therapy, with vasopressors and inotropes being indicated in those patients who do not respond adequately to fluids. Therapy directed against the mediators of septic shock is theoretically promising, but to date has not been successful.

Protean manifestations of herpes infection in AIDS cases

Herpes simplex virus (HSV) is one of the most common opportunistic infection in the human immunodeficiency virus- (HIV) infected adults. HIV and HSV are co-transmitters of each other. Atypical and more serious clinical manifestations of HSV infection occur in the setting of HIV-induced immunosuppresion. A study was carried out at HIV referral clinic, Govt. Medical College, Vadodara during the period February 2003 to October 2004. Two hundred cases of HIV-positive patients with mucocutaneous manifestations were examined. On the basis of history, clinical features, and biopsy, 50 patients were suspected to have herpes. Among them, genital lesions (18%) were the commonest manifestation followed by oral lesions. Prompt diagnosis, screening of females for cervical herpes, prophylaxis, and early administration of acyclovir therapy is of immense benefit.

167Reduction in Contaminated Blood Culture Rates and Associated Costs as an Antimicrobial Stewardship Program Activity

167. Reduction in Contaminated Blood Culture Rates and Associated Costs as an Antimicrobial Stewardship Program Activity John Toney, MD; Narla Fries, CLS, MT(ASCP); Rey Rivera, MD; Stephen Mastorides, MD; Richard Oehler, MD, FACP, FIDSA; Sandra Gompf, MD; Infectious Disease Section, James A. Haley Veterans’Hospital, Tampa, FL; Pathology and Laboratory Medicine Service, James A. Haley Vaterans Hospital, Tampa, FL; Infectious Disease and International Medicine, University of South Florida, Tampa, FL; Division of Infectious Disease and International Medicine, University of South Florida, Tampa, FL; Infectious Disease Section, James A. Haley Veterans Hospital, Tampa, FL

Late congenital syphilis with stigmata

Congenital syphilis is a rare entity and is an indicator of sexually transmitted diseases in a given population. We are reporting a case of late congenital syphilis presenting with palatal perforation at an age of 13 years.