Abstract
Schwarzenegger Makes Drastic Aids Program Cuts
C
The cuts include an 80% reduction in funding for education and prevention, a 70% cut in HIV counseling and testing, and a 50% cut for early intervention that provides primary medical care. In addition, there is a 100% cut in the therapeutic monitoring program designed to monitor the effectiveness of drugs administered through the state's AIDS Drug Assistance Program (ADAP). The newly approved budget also includes a 20% cut in housing and more than a 50% cut in funding for home and community-based care.
AHF has called the governor's cutbacks “a heartless act” that will “cost California taxpayers millions more in the future.” With HIV testing programs sidelined and the state's ability to prevent new infections stymied, new infections in California will increase. Each new infection can mean up to $600,000 dollars in lifetime health care costs. A 100% cut to the therapeutic monitoring program is the “definition of penny-wise and pound-foolish,” according to the agency. As they see it, the state's already cash-strapped ADAP will only end up spending more for drugs.
Excreted Urine Protein May Help Diagnose HIV-Related Kidney Disease
New data collected at Columbia University Medical Center and by the Mount Sinai School of Medicine are helping to explain how the protein NGAL plays a significant role in chronic HIV-related kidney disease. NGAL is not only a marker for the disease but also distinguishes HIV-associated nephropathy (HIVAN) from more common causes such as diabetes and hypertension.
The current study represents the examination of data from human cohorts in New York and Parma, and from mouse models. NGAL, which stands for neutrophil gelatinase-associated lipocalin, is a protein previously discovered by the researchers in damaged kidneys. In this current study, NGAL was prominently expressed in kidney tissue and in the urine of humans and in mouse models of HIVAN. The high levels of the urine protein were out of proportion to the degree of chronic renal failure that typifies patients with other types of chronic glomerular diseases of both mice and humans. Most strikingly, the researchers noticed that the rise in urinary NGAL levels was in conjunction with the development of a specific type of lesion, namely tubular cysts that typify HIVAN. The association with these cysts consequently may justify their biopsy or an aggressive treatment with antiretroviral drugs when high levels of urine NGAL are discovered. The researchers say that more studies are needed in much larger human cohorts to determine the precise relationship of NGAL to HIVAN and whether the protein is a good enough predictor of tubular cysts.
NGAL expression, which is induced in kidney disease and damage, can help identify patients at risk for kidney failure even in those without HIV. Last year, the researchers found that approximately 65% of patients with NGAL protein in the urine upon presentation to the emergency department will require care by a nephrologist. Another 32% will need dialysis, and 29% will require care in the intensive care unit, over the course of a week following the subsequent hospitalization.
More details about the study were published ahead of print on July 24 in the Journal of the American Society of Nephrology.
Agency Recommends Syphilis Screening for All Pregnant Women
The U.S. Preventive Services Task Force (USPSTF) has issued a new update of their 2004 statement about screening for syphilis in pregnancy. In it, they recommend screening of all pregnant women for syphilis infection, giving it a Grade A recommendation. Untreated syphilis during pregnancy is associated with stillbirth, neonatal death, bone deformities, and neurologic impairment.
An expert panel conducted a targeted literature search for evidence on the benefits of screening, the harms of screening, and the harms of treatment of syphilis with penicillin during pregnancy. They found adequate evidence that screening tests can accurately detect syphilis infection. Observational evidence was also found showing that the universal screening of pregnant women decreases the proportion of infants with clinical manifestations of syphilis infection.
According to the USPSTF, screening and treatment may result in potential harms, including false-positive results that require clinical evaluation, unnecessary anxiety to the patient, and harms of antibiotic use. However, the Task Force concluded that the harm from screening is small.
Nontreponemal tests commonly used for initial screening are the Venereal Disease Research Laboratory (VDRL) test or the rapid plasma reagin (RPR) test. These are typically followed by a confirmatory fluorescent treponemal antibody absorbed test or Treponema pallidum particle agglutination (TPPA) test.
All pregnant women should be tested at their first prenatal visit. For women in high-risk groups, many organizations recommend repeated serologic testing in the third trimester and at delivery. Most states mandate that all pregnant women be screened at some point during pregnancy, and many mandate screening at the time of delivery. Follow-up serologic tests should be obtained after treatment to document decline in titers. To ensure that results are comparable, follow-up tests should be performed by using the same nontreponemal test that was used initially to document the infection (for example, VDRL or RPR).
Pregnant women who are at increased risk for syphilis infection include uninsured women, women living in poverty, sex workers, illicit drug users, and women in communities with high syphilis morbidity. The prevalence of syphilis infection differs by region and ethnicity. For example, it is higher in the southern United States and in some metropolitan areas than it is in the United States as a whole. Prevalence is also higher in Hispanic and African-American populations than in the White population. Persons in whom sexually transmitted diseases have been diagnosed may be more likely than others to engage in high-risk behavior, which places them at increased risk for syphilis.
The Centers for Disease Control and Prevention (CDC) has outlined appropriate treatment of syphilis in pregnancy (
The complete guidelines and their rationale were published in the Ann Intern Med 2009;150(10):705–709, 710–716.
Study Shows the Value of Peer Education
African-American adolescents have some of the highest rates of HIV infection in the United States. Efforts to educate them about preventing the disease must include the help of their adolescent peers, according to new research conducted by researchers at Georgetown University School of Medicine.
Despite comprising only 15% of the population, young African-Americans make up 61% of the new HIV cases among people under age 25. In the region of North Carolina where the new study took place, 85% of HIV cases occur among African-Americans. In their study, the researchers discovered that the interviewed youth did know that HIV was very prevalent and that everyone could be affected.
The study asked young people about what types of community-based HIV intervention programs worked best in reaching their peer group. Four focus groups were held with 38 young African-Americans (between ages 16 and 24) who live in two rural North Carolina counties. The participants' said that sexuality and HIV prevention should be taught at a much younger age (before puberty) rather than to older adolescents in an effort to “catch them while they're young.” The focus groups also felt that people already living with HIV/AIDS could deliver the most effective messages for prevention.
Another finding of the focus groups was that young people should undergo training to become peer educators. They are more likely than adult educators to get the attention and investment of other youth. According to the researchers, peers are sex educators, whether adults like the idea or not.
The study will be published in the winter issue of the journal Progress in Community Health Partnerships: Research, Education and Action 2009;3(4).
Safety Data Completed for Immune-System Modulator
Safety testing has been completed on the HIV immune modulator Cytolin®, being developed by CytoDyn. Tests were performed for specific adventitious agents and other quality parameters following purification. Other safety tests, including in vivo general safety using two animal species, were also conducted. Since the product is intended for use in a clinical trial, the tests conducted were those required for each new batch of a biologic agent manufactured for use in human research. In previous human studies, multiple infusions of Cytolin were well tolerated.
Cytolin is an immune modulator intended for use in combination with antiretrovirals to prevent the emergence of drug-resistant HIV. Currently, the manufacturer is negotiating with an East Coast university to conduct the next clinical trial. The purpose of the study would be to confirm and elaborate the immunologic mechanisms believed responsible for the clinical benefits observed in earlier human studies. To date, Cytolin has only been used in approximately 200 patients. It has not been used in human subjects for periods in excess of 18 months.
Screening for HBV Reaffirmed by Task Force
The U.S. Preventive Services Task Force (USPSTF) has once again reaffirmed its 2004 recommendation on screening for hepatitis B virus (HBV) infection in pregnancy. According to the Task Force, the net benefit of screening continues to be well established. Pregnant women should be screened for HBV at their first prenatal visit. The net benefit of screening pregnant women for HBV infection is substantial.
An estimated 24,000 infants are born each year to women in the United States who are infected with HBV. Between 30% and 40% of all chronic HBV infections are the result of perinatal transmission. Chronic HBV infections increase long-term morbidity and mortality by predisposing infected persons to cirrhosis of the liver and liver cancer.
The principal screening test for detecting maternal HBV infection is the serologic identification of hepatitis B surface antigen (HBsAg). Immunoassays for detecting HBsAg have a reported sensitivity and specificity greater than 98%. Screening for HBV infection by testing for HBsAg should be performed in each pregnancy, regardless of previous hepatitis B vaccination or previous negative HBsAg test results.
A test for HBsAg should be ordered at the first prenatal visit with other recommended screening tests. At the time of admission to a hospital, birth center, or other delivery setting, women with unknown HBsAg status or with new or continuing risk factors for HBV infection (such as injection drug use or evaluation or treatment for a sexually transmitted disease) should receive screening.
The USPSTF found convincing evidence that universal prenatal screening for HBV infection substantially reduces perinatal transmission of HBV and the subsequent development of chronic HBV infection. The current practice of vaccinating all infants against HBV infection and providing postexposure prophylaxis with hepatitis B immune globulin administered at birth to infants of mothers infected with HBV substantially reduces the risk for acquiring HBV infection.
Infants born to HBV-infected mothers should receive hepatitis B vaccine and hepatitis B immune globulin within 12 hours of birth. Infants born to mothers with unknown HBsAg status should receive hepatitis B vaccine within 12 hours of birth, followed by hepatitis B immune globulin as soon as possible (but not later than 7 days after birth) if the mother tests positive for HBsAg.
Pregnant women who test positive for HBsAg should be referred to an appropriate case-management program and should be provided with or referred for counseling and medical management of HBV infection. Counseling should include information about prevention of HBV transmission to sexual partners and household contacts and reassurance regarding the safety of breastfeeding in infants who receive appropriate prophylaxis.
Screening for HBV infection in pregnant women is necessary but not sufficient to prevent disease transmission to newborns. To realize the maximum benefit from screening, primary care clinicians and delivery settings must establish effective systems for the accurate and timely transfer of maternal HBsAg test results to the labor, delivery, and newborn medical records.
The recommendations were published in the June 16th issue of the Annals of Internal Medicine, 2009;150(12):869–873, W154.