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December 2001

The Newsline section recalls the pioneering HIV/AIDS publication of the same name produced by the People With AIDS Coalition of New York (PWAC-NY).

Medicaid Pays More for Drugs

A new report by the Department of Health and Human Services Inspector General says that Medicaid pays up to one-third more than other federal programs for expensive AIDS drugs.

Medicaid, a federal-state health insurance program for poor and disabled Americans, pays prescription drug costs for about 45 percent of the 335,000 Americans with AIDS who receive regular care. In 1999, the program spent $617 million on 16 AIDS drugs. That is 33 percent more than the maximum price paid by the Veterans Administration (VA), the Department of Defense, the Public Health Service and the Coast Guard, the Inspector General said in the report. On average, Medicaid pays 61 cents more per pill, or $66 more per prescription, than these other agencies.

The report examined 10 states with the largest AIDS populations and estimated the national numbers based on those figures. States can set their own prices for Medicaid drugs, but most states base prices on the inflated average wholesale price. Some states pay more than others. Massachusetts pays 24 percent more than the maximum price set for the VA and Defense Department. Maryland pays 33 percent more. Georgia tops the list, paying 55 percent more. If the nine other states examined had paid Massachusetts' prices, they would have saved $24.5 million.

Part of the problem is that federal law requires states to cover all AIDS drugs if they cover any of them, meaning states can't threaten to drop a particular drug from the approved list during price negotiations. Another problem cited by the report indicates that states don't have much information about how much drugs actually cost, making negotiations difficult. "States are working blind," said Matt Salo, a Medicaid expert at the National Governors' Association. (Associated Press, 08.01.01)

Progress in AIDS Fight Leading to a Growing Number of Transplants for HIV-Positive Patients

Five years ago, doctors and insurers routinely rejected AIDS patients for transplants because of their lower life expectancies and the unproven benefits of surgery in such patients. In the last few years, as new drugs have significantly increased the life expectancies of HIV patients, doctors are beginning to perform more transplants. In 1999, five transplants were reported to the United Network for Organ Sharing and in 2000 there were 11. However, many doctors still don't support transplants for HIV patients; only 37 transplants have been done on HIV patients in the last 12 years, according to the organ network.

The University of California San Francisco Medical Center is organizing a clinical trial in as many as 15 US hospitals -- the largest of its kind for HIV transplant patients, said Dr. Peter Stock, a transplant surgeon involved in the study. Once the clinical trial is completed, he said, insurance companies may be less likely to consider the procedure experimental. "In order to get the insurance companies to pay, you have to show that it's safe and effective," he said.

Empire Blue Cross and Blue Shield changed its policy earlier this year to allow people with HIV to be considered for transplants. The main reason for this change is the improved prognosis for people with HIV since the widespread use, beginning in 1996, of highly active antiretroviral drugs, known as HAART regimens. According to Dr. Alan Sokolow, Empire's chief medical officer, "Now that we know more about how HIV transplants interact, it's possible to consider certain situations of HIV infection to be acceptable conditions for transplant." (Associated Press, 08.03.01, Denise Lavoie)

Healthy Skepticism and the Marketing of AIDS

The Food and Drug Administration (FDA) has ordered several pharmaceutical companies to pull advertising for AIDS drugs that depicted robust young men heaving javelins, riding bikes and crewing on sailboats. The FDA said such portrayals were "not generally representative of HIV patients and do not adequately convey that these drugs neither cure HIV infection nor reduce its transmission."

Truth in advertising has long been considered an oxymoron. From political campaign spots to the perfect grill marks on hamburgers in Burger King ads, advertisers have always improved upon reality. But the practice is much more contentious when it comes to medical advertising. After all, the risks associated with embellishing the appearance of fast food are appreciably lower than those having to do with creating misconceptions about HIV and AIDS.

Misinformation has been spread by the advertising used to promote AIDS drugs, said Natasha Jenkins, an infectious disease market analyst in London for Datamonitor Healthcare, which does research for drug company advertising campaigns. Since 1997, when the FDA first allowed drug companies to market directly to consumers, "They have made it seem like there is a cure and a lot of people have stopped taking the same precautions because they feel that AIDS is being controlled by drugs," said Jenkins.

"There is obviously a tradeoff in wanting and letting people know that there are treatments for HIV infection," said Dr. Ronald Valdiserri, deputy director for the AIDS center at the CDC. "But we also don't want to go so far that we minimize what is still a lifelong, incurable disease." Christine G. Sinnock, a social worker at St. Jude Children's Research Hospital in Memphis who works with children and young adults with HIV/AIDS, points to polls showing that although 75 percent of Americans thought AIDS was the country's most pressing health problem in 1987, that number had dropped to 45 percent in 1995 and to 26 percent by last year.

"The numbers make it seem as if we had found a cure, but it is really just that the drug companies are winning the image game," Sinnock said. (New York Times, 08.05.01, Jayson Blair)

Women Now Look Beyond HIV, to Children and Grandchildren

A few years ago it was almost unheard of for a woman who knew she was infected with HIV to attempt to become pregnant. Most women who knew they were HIV positive were not willing to risk the 25 percent chance that they would have a child infected with the virus. But now, with a regimen of medication, an HIV positive woman can reduce the chance of infecting her child to almost zero. Armed with this information, small but increasing numbers of HIV-positive women are deciding to have children.

Experts say the reduction in mother-to-child transmission is one of the few success stories in the 20-year history of AIDS in America. "As far as perinatal transmission, there has been a remarkable change over the last decade," said Dr. Howard Minkoff, chair of obstetrics and gynecology at Maimonides Medical Center in Brooklyn. "Overall, the risk of an American woman having a child with a major birth defect is 2 to 3 percent. In comparison, an HIV-infected woman who does everything right can be reasonably sure that there is a 99 percent chance that her baby will be born free of the virus."

The CDC estimates that every year 6,000 HIV-infected women give birth in the United States, and most are on some kind of antiretroviral therapy. In the era before medication was recommended for pregnant HIV-infected women, 1,000 to 2,000 babies were born with the virus each year. Since 1992, there has been a vast decrease in children born with HIV. Now about 300 to 400 HIV-infected babies are born each year.

Despite the improved outlook, researchers remain troubled by the possibility of long-term effects from very potent medication on both mother and child. "None of the drugs are nontoxic," said Dr. Lynne M. Mofenson, associate branch chief for clinical research at the Pediatric, Adolescent and Maternal AIDS Branch of the National Institutes of Health. "These findings should not deter women from taking the medication, but it's very important to acknowledge that babies need follow-up long-term to monitor any potential effects in the future." (New York Times, 08.07.01, Linda Villarosa)

Reducing HCV Load in People With HIV

A clinical study has found that interferon/ribavirin combination therapy is more effective than interferon monotherapy at reducing hepatitis C (HCV) viral load in HIV-infected persons in the first 12 weeks of treatment. It further showed that combination therapy appears to be as safe as monotherapy and does not exacerbate anemia in coinfected patients.

The study included 110 coinfected patients from clinical research centers in 16 US cities and Puerto Rico. After 12 weeks of treatment, 23 percent of patients receiving combination therapy had no detectable hepatitis C viral load, while only 5 percent of patients receiving monotherapy had no detectable viral load (p=0.016). Anemia was one of the most commonly reported adverse events in the study, although there was no statistically significant difference in incidence of anemia between the two groups.

Hepatitis C infects as many as 40 percent of Americans with HIV/AIDS. HIV can greatly accelerate the progression of HCV. HCV and other liver-related conditions are now a leading cause of death among people with HIV/AIDS and are also the leading cause of liver transplantation in the United States. "The results shed new light on treatment issues related to specific populations, including women, people of color, and injection drug users, who account for a significant percentage of the coinfected population," said Jeffery Smith of amfAR. (Hepatitis Weekly, 08.06.01)

AIDS in Black America: Denial Equals Death

African-Americans are now contracting HIV/AIDS at an astoundingly high rate. AIDS is ravaging the community and motivating African-American leaders to do something about it. They are working with and starting various outreach programs, acquiring grant money, and working within the church.

However, a number of barriers in the African-American community make it difficult to accomplish some of the work that needs to be done. One set of barriers are the psychosocial issues that keep minorities from learning the facts about HIV and treatment. Evidence suggests that African-Americans distrust the government. The infamous Tuskegee syphilis experiment study created a mistrust of the public health establishment. In addition, both young and old African-Americans have historical knowledge that has developed into a belief system. If their parents did not go to the doctor, young African-Americans have learned also not to seek medical care.

The black community is in a state of emergency. African-Americans have been politically and economically disenfranchised, leaving fertile ground to breed diseases. Much has been done to correct this, but there is still much work to do. (Rolling Out (Atlanta), 07.19.01, Nina Moore Walker)

Hep C: The Next HIV?

David Bernstein, chief of hepatology at North Shore University Hospital in Manhasset, N.Y. on Long Island, is all too familiar with "hep C." As he knows, hepatitis C, a master of stealth, can burrow in the liver for up to 20 years before provoking such symptoms as fatigue, jaundice and abdominal pain.

One mystery is why some patients never suffer from its effects. By the time a biopsy confirms the diagnosis, the disease is in its chronic stage, often with severe scarring of the liver and the threat of cancer and death. "For now we don't have a way of predicting who will wind up in that shape," said Richard Manch, liver specialist at Good Samaritan Regional Medical Center in Phoenix.

Four million people in the United States and 200 million people worldwide are infected with hepatitis C; 200,000 people get treatment in the United States, and that could double in four years. The virus, contracted through intravenous drug use or blood transfusion, was first spotted in 1989, and screening for it began in 1992. The CDC says that up to 10,000 people died from hepatitis C last year and that by 2010, the annual death toll will overtake that of HIV.

The current gold standard of treatment is Schering-Plough's Rebetron, a combination of the antiviral capsule ribavirin and the cancer drug interferon. Separately they have little effect, but together they prevent hepatitis C from spreading by causing it to make defective virus cells. Currently, the pharmaceutical industry and biotech companies are conducting research to develop new medicines to tackle hepatitis C.

In the race pitting science against microbes, however, the spread of hepatitis C looks likely to outrun a cure. "The disease isn't becoming an epidemic," said Bernstein. "It is an epidemic." (Forbes, 08.20.01, Rob Wherry)

Hepatitis B Virus: Transmission, Prevention, Treatment and HIV Co-Infection

High rates of hepatitis B virus (HBV) occur in people who have multiple sex partners, people who have percutaneous blood exposures (those who share injecting drug equipment and patients on hemodialysis), and health care or public safety workers who have frequent exposure to contaminated blood or other infectious fluids.

HBV infection is very common, with more than 350 million chronically infected people worldwide, including 1.25 million in the United States. Twenty to 80 percent of US inmates have past or active HBV infection, and 0.8-1.4 percent of inmates acquire HBV while in prison. In the correctional environment, tattooing with contaminated needles may be associated with HBV acquisition. Correctional officers may also be at increased risk of HBV infection because of exposure to inmates' blood and other body fluids during the course of their work. Since HIV and HBV have similar modes of transmission, co-infection is quite common.

A CDC meeting convened this spring on hepatitis in correctional settings attracted more than 100 federal and state correctional healthcare professionals. CDC speakers discussed the need to expand HBV and hepatitis C virus (HCV) interventions, including screening, education, vaccination and treatment of chronic hepatitis in correctional settings. The CDC will issue guidelines for HCV and HBV management as a supplement to its Morbidity and Mortality Weekly Report in the fall.

Only 25-50 percent of cases of acute HBV are symptomatic; the remainder are asymptomatic or are associated with inconsequential symptoms. Following an incubation period that varies from one week to six months, symptoms of the pre-icteric phase include malaise, weakness, anorexia, nausea, vomiting and upper right quadrant pain.

There is no specific therapy for acute viral hepatitis. Supportive therapy including intravenous fluids, antiemetics, mild analgesia, and antipyretics may be necessary in some cases. Avoiding contact with contaminated blood by using universal precautions is the only way to be 100 percent protected against HBV infection.

HIV and HBV interact when they occur in the same host. Like any other infection that occurs in HIV-positive individuals, HBV infection activates the immune system leading to proliferation of CD4 cells which enhances HIV replication and increases plasma HIV RNA (viral load). In addition, HBV proteins directly stimulate HIV replication. Although the literature does not consistently support the presumption that HIV progression is accelerated by concomitant HBV infection, it does appear that HIV infection may accelerate the progression to hepatic failure and hepatic failure-related deaths in patients with chronic HBV infection. Patients with chronic HBV and HIV are more likely to have clinically significant hepatotoxicity when placed on antiretroviral agents in general and may have increased incidence and severity of indinavir-associated hyperbilirubinemia.

Adults in high-risk groups should be vaccinated but vaccination of all adults is not recommended at this time; older adults are at lower risk. The incidence of acute HBV infection in the United States has declined from 450,000 new infections per year in the 1980s to 80,000 in 1999. Vaccination against HBV, which has been available since 1982, is primarily responsible for this decline. (HIV & Hepatitis Education Prison Project HEPP News, 07.01, Vol 4; No 6/7; P 1-4; David Paar, M.D.)

Antiretroviral Therapy for Previously Treated Patients

Antiretroviral therapy is most effective the first time it is prescribed. Suppression of plasma HIV-1 RNA to undetectable levels occurs up to 90 percent of the time when patients begin their first triple-drug regimen. Achieving this level of suppression decreases with each subsequent treatment regimen, with only one-third or less of patients having previous exposure to two or more classes of antiretroviral drugs achieving undetectable levels of HIV-1 RNA.

In their editorial responding to the Albrecht et al. article in this issue of the New England Journal of Medicine, Montaner and Mellors stress that the overall response rate of patients with persistent viremia in the quadruple-therapy group (participants who received nelfinavir, efavirenz and two nucleoside reverse-transcriptase inhibitors) points to "the importance of prescribing, whenever possible, at least two drugs of new classes for patients who have already received treatment. . . ." In patients with previous exposure to all three classes of antiretroviral drugs, "regimens containing four or five drugs have achieved suppression of viral replication in only 15 percent of patients. This response rate is dismal and warrants a call to action for clinicians, scientists, and leaders in industry and government."

"What can be done for this most challenging group of patients?" the authors ask. While encouraging preliminary results indicate success with multi-drug regimens of six or more approved antiretroviral drugs, the approach can cause serious toxic effects. High levels of exposure to drugs may help to overcome moderate drug resistance and "the use of ritonavir to boost the serum levels of other protease inhibitors has improved the rates of viral suppression in patients in whom regimens containing protease inhibitors have previously failed."

The promise of new agents is no guarantee of success, since the staggered release of new antiretroviral agents into clinical practice "often results in the addition of only one new drug at a time to a failing regimen, rather than the more effective simultaneous addition of at least two new drugs, as illustrated by Albrecht et al.," the authors argue.

Finally, there is the problem of the lack of any requirements for studying new antiretroviral agents in patients with previous exposure to all three classes of drugs. "The current regulatory requirements are not helping the most desperate patients. We need greater cooperation among academic, industry and regulatory agencies to improve the outlook for patients for whom effective treatment options are currently lacking," say the authors. (New England Journal of Medicine, 08.09.01, Vol. 345; No. 6; P 452-461; Julio S. G. Montaner, M.D.; John W. Mellors, M.D.)

Implants Limit HIV Wasting Facial Change

The loss of facial fat is characteristic of HIV infection, causing many otherwise healthy patients to lose their self-esteem -- even to the point of becoming shut-ins. But the appearance of facial lipoatrophy improved in 16 patients who underwent the surgical insertion of Gore-Tex multistrand implants, Dr. Alastair Carruthers of the Carruthers Dermatology Center in Vancouver told the recent annual meeting of the Canadian Dermatology Association.

In the procedure, Carruthers creates a tunnel beneath the area of facial hollowing and pulls one or more Gore-Tex implants under the skin to fill out the areas of fat loss. Some swelling is associated with the procedure and adds to the initial improvement in appearance. After approximately two months, however, the initial swelling has faded and some lumpiness typically is evident in the implanted areas. At this time, Carruthers reassesses the patient to see if more implants are needed. About three out of four patients have required a second implant procedure. For those with lumpiness remaining at three months, Carruthers has injected silicone oil. This substance can be difficult to inject but remains in place better than collagen and other filler materials.

Carruthers reported "zero complications" in the 16 patients on whom he has performed the procedure. "Even the scars healed better than I would have expected," he said. Most patients requesting the procedure have low or undetectable viral loads. They have been pleased with the results, he said.

Lipoatrophy of the face and extremities and fat redistribution on the trunk have increasingly been recognized in HIV-positive patients. Initial reports suggested that this was a drug-related phenomenon, most likely associated with protease inhibitors. But subcutaneous fat loss is also seen in patients who have never received any HIV treatment, so HIV infection itself and other factors appear to contribute to the condition, Carruthers said. (Internal Medicine News, 08.15.01, Nancy Walsh)

All articles were abstracted by the National Prevention Information Network (NPIN) of the US Centers for Disease Control and Prevention (CDC).

Back to the December 2001 issue of Body Positive magazine.

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This article was provided by Body Positive. It is a part of the publication Body Positive.