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January 2000 Treatment Chronicles

From the CDC National AIDS Clearinghouse

January 2000

CDC Allocates $32 Million for HIV Prevention. The Centers for Disease Control and Prevention announced October 5 that it has allocated $32 million to increase HIV prevention efforts in minority communities. According to statistics, 1 in 50 African-American men and 1 in 160 African-American women is infected with HIV. In addition, Hispanics account for 20 percent of new HIV cases. The grant from the CDC will be given to over 100 African-American community groups, organizations for minority gay men, and African-American religious organizations.

AIDS Deaths, Homicides, Teen Birth Rates Fall in US. A report released by the CDC's National Center for Health Statistics shows that the age-adjusted HIV mortality rate in the United States declined 21 percent last year. A CDC spokesperson noted that while there has been a drop in AIDS deaths, there has been no similar type of decline in cases of AIDS. Other statistics from the NCHS reveal that the preliminary age-adjusted homicide rate fell 14 percent in 1998, while the teenage birth rate dropped two percent.

Many HIV Patients Report Better Quality of Life. A new survey reveals that 49 percent of HIV-infected patients consider their lives better now than before being infected. Eighteen percent said their lives were the same, and 29 percent said their lives were worse. The study involved 85 patients, with 51 involved in the main analysis and 34 involved in focus groups that led to the development of a structured questionnaire. HIV patients reported that they have discovered the important things in life, removing trivial problems. One surprising finding was that, on average, patients did not want to give up more than five percent of their current life expectancy in return for being perfectly healthy, while nearly 50 percent did not want to exchange any time at all, according to author Joel Tsevat of the University of Cincinnati Medical Center.

Many Physicians Fail to Recognize Symptoms in HIV-Infected Patients. French researchers performed a cross-sectional survey of 290 HIV-infected patients to compare reported symptoms with the treatments prescribed. The study, published in the October issue of the Journal of Pain and Symptom Management, determined that physicians treating HIV patients need to be better at identifying patients' symptoms. Often, the doctors paid attention only to measurable physical symptoms such as fever or weight loss, granting more attention when the patient became sicker. The scientists also noted poor physician recognition rates for symptoms associated with treatment side effects and for symptoms of treatable conditions, including sleep problems and diarrhea.

Emergency Treatment to Stop AIDS Virus. AIDS doctors are increasingly using an experimental treatment in an effort to prevent HIV infection in persons who were recently exposed to the virus after participating in unsafe sex. Post-exposure prophylaxis uses the standard drugs taken by individuals with AIDS, including the antiretrovirals AZT and 3TC for between seven and 30 days. In some cases, non-nucleoside reverse transcriptase inhibitors, such as Sustiva or nevirapine, are included in the regimen. Those who favor the prophylactic method point to the success in preventing vertical transmission of the virus from pregnant women to their unborn infants. By using the prophylactic regiment, such transmission rates have been cut from 25 percent to less than five percent.

FDA Panel Won't Recommend Approval for Gilead Sciences' AIDS Therapy. Concerns about safety have led a panel convened by the U.S. Food and Drug Administration to recommend that the full agency not give Gilead Sciences permission to market adefovir, a new AIDS therapy intended for use in patients with resistance to existing drugs. A number of the 214 patients in clinical trials developed kidney damage, requiring some individuals to undergo dialysis. The panel also pointed out that a significant portion of subjects failed to complete the trials and said it was not convinced of the drug's efficacy. Gilead Sciences could halt research on adefovir and focus more efforts on tenofovir, which is similar but is not linked to any serious side effects.

Costs of Antiretroviral Drugs Dramatically Increase in US. According to a study led by Dr. Abid Rahman with the U.S. Department of Veterans Affairs (VA), the costs of AIDS treatment rose 434 percent for the VA between 1992 and 1998. At the Third International Conference on Healthcare Resource Allocation for HIV/AIDS and Other Life-Threatening Illnesses in Austria, Dr. Rahman noted that the number of antiretroviral drug prescriptions the VA system filled between 1992 and 1998 soared 546 percent. In addition, the AIDS/HIV Drug Utilization study found that whereas antiretroviral drugs represented nearly half of overall pharmacy costs at the beginning of the study, that figure rose to 78 percent by 1998.

Disease by Disease: AIDS, Infectious Diseases. Medical advances are helping to improve the outlook for many patients, leading to possible changes in treatment, diagnosis and prevention of leading diseases. Combination drug therapy, for example, has resulted in a significant reduction in the AIDS mortality rate. The drugs, however, do not appear to have the ability to completely eliminate HIV from the body -- a situation that has frustrated many researchers. Two other problematic areas are the price of the HIV therapies and the emergence of drug-resistant HIV strains. Drug resistance is also an issue for other diseases, including pneumonia and skin and blood infections. Increasing use of potent new drugs has helped bacteria mutate into never-before-seen forms. One way researchers are trying to fight drug resistance involves discovering the genetic code of diseases, using their structure to find new methods of attacking microbes. In recent years, scientists have deciphered the genetic codes of the germs that cause syphilis, malaria and tuberculosis.

Ongoing HIV Dissemination During HAART. Researchers studied the kinetics of plasma HIV RNA in patients' highly active antiretroviral therapy (HAART) with up to five drugs. The researchers theorized that HIV replication takes place in many local bursts, so while the drugs can reduce the size of bursts, they cannot completely abolish them. After testing the hypothesis using measurements of viral loads and decay rates, the scientists present data indicating that it could be very difficult to eradicate HIV using only drugs. In fact, they say the usefulness of drug therapy at present may be overestimated. According to the authors, "The idea that HIV is produced in multiple, hard-to-abolish, local bursts, whose size is very sensitive to relatively small changes in blocking efficiency...[suggests that] stimulating all latently infected cells to produce virus under the cover of HAART, with the goal of eradication, may actually result in transmission to new cells." It is possible, however, that transmission could be halted with antiretroviral drugs that are more effective than those currently available.

HAART Prolongs Time to Kaposi's Sarcoma Treatment Failure. A retrospective study conducted by U.K. researchers has found that highly active antiretroviral therapy (HAART) delays the onset of Kaposi's sarcoma (KS) treatment failure in patients with HIV. The study, published in the November issue of AIDS, evaluated 78 HIV-infected patients previously treated for KS who were put on HAART. The results showed that the median onset of KS treatment failure increased from 0.5 years before starting HAART to 1.7 years after the treatment was begun.

HHV8 Gene Identified That May Speed Progression of Kaposi's Sarcoma. European researchers recently reported in the Journal of the National Cancer Institute that a human herpes virus 8 (HHV8) gene appears to speed the progression of Kaposi's sarcoma (KS). Led by Dr. Michael Sturzl of the Institute for Molecular Virology in Neuherberg, Germany, scientists studied 14 KS biopsy specimens, all but two of which were from patients with AIDS-related KS. The results of the study show that an increase in expression of v-FLIP, an antiapoptotic protein, may explain the sudden, rapid growth seen in the late stages of KS. An editorial by Dr. Gary Howard of the Johns Hopkins School of Medicine notes that the risk of developing KS within 10 years could be up to 50 percent in HHV8-infected AIDS patients.

Call to Buy Nevirapine for Developing Countries. The results of a joint trial between the United States and Uganda, called HIVNET012, indicate that the drug nevirapine can reduce perinatal HIV transmission by 47 percent. As a result, the Elizabeth Glaser Pediatric AIDS Foundation recently put a full-page advertisement in the New York Times asking for $12 million to help reduce the number of HIV-infected newborns. The foundation -- which calculated the price based on the number of HIV-infected pregnant women in the world, the price of nevirapine, and implementation costs -- will distribute the money, with preference given to areas that demonstrate they can help pregnant women with the necessary infrastructure. Already, the Glaser Foundation has committed $1 million, while the Global Strategies for HIV prevention organization and the International AIDS Society have each agreed to give $10,000.

Triangle Drug Cocktail Suppresses HIV. A 48-week, randomized, double-blind study of 162 HIV-infected patients tested a drug cocktail involving Triangle Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor, Coactinon. The therapy, which also included d4T and 3TC, was found to significantly suppress HIV replication. After 24 weeks, 83 percent of those given the combination therapy had undetectable levels of the virus. Triangle reported that the drug had mostly mild side effects, including nausea, headache, dizziness, diarrhea, and rash.

U.S. Bioscience Suspends Test of AIDS Drug Lodenosine. Just three weeks after agreeing to be acquired by MedImmune, U.S. Bioscience said it halted clinical trials of its AIDS drug lodenosine because one patient died and others exhibited signs of potential liver or kidney damage. Company officials noted that all patients in the trial have stopped using lodenosine and were still taking other drugs used in the trial, including Merck's Crixivan and Bristol-Myers Squibb's Zerit. The company indicated that the problems were discovered after positive preliminary results were reported at a meeting in San Francisco in September. U.S. Bioscience plans to review the data and work with the Food and Drug Administration to decide on a future course of action, which could include indefinitely suspending the testing.

Inexpensive Hydroxyurea/Didanosine Combination Controls HIV Long Term. A recent study published in the journal AIDS Research and Human Retroviruses by American and Italian researchers has found that HIV infection can be suppressed with hydroxyurea and didanosine. The study found that in 12 HIV-infected patients, treatment with the inexpensive combination can reduce viremia and that the antiviral response to initial treatment can last for an extended amount of time. The patients were treated for an average of 122 weeks.

Low-Dose Ritonavir Extends Half-Life of Indinavir. A new study in the journal AIDS indicates that adding ritonavir to indinavir in a twice-daily dosing regimen increases the pharmacokinetic profile of indinavir. Scientists from the Netherlands evaluated three cocktail variations in 12 patients infected with HIV. The investigators found that the peak concentration of indinavir was higher and trough levels lower when patients were given 1200 mg. two times a day, when compared to results from patients given 800 mg. indinavir plus 100 mg. ritonavir; the addition of the ritonavir dosage raised the chance of toxicity, and patients on that combination suffered more side effects. In comparison, adding the same dose of ritonavir to 800 mg. indinavir twice daily improved the pharmacokinetic profile.

BioChem Pharma Bets It Can Grow by Going It Alone. In 10 years, BioChem Pharma, maker of the AIDS drug 3TC, has managed to transform itself from a little-known biotechnology concern into a well-known company. Although 3TC's total sales topped $800 million last year, BioChem Pharma has reaped only a small percentage of those gains because it licensed the compound to Glaxo Wellcome. Now, in an effort to improve growth and reduce its dependence on its giant partner, the Canadian company is hoping to reduce the amount of research it licenses and take charge of the commercialization of its own products. BioChem's ability to style itself like Amgen and Biogen will be largely dependent on the continued healthy sales of 3TC, in both the AIDS and hepatitis segments.

FDA Says Immunex's AIDS Claims Are "Misleading." Immunex Corp. has been warned by the FDA that its claims about the cancer drug Leukine helping fight HIV are misleading. An Immunex press release in May said that a Phase III clinical trial found that Leukine helps keep HIV levels down and enabled patients to take combination drug therapy for longer periods without developing drug resistance. Immunex has since stopped distributing the press release and has taken it off its website, but it is unknown if the company agrees with the FDA, which says the company's conclusions were based on unblinded data.

HIV-Associated Dementia Complex Linked to Productive Infection of the Brain. The November issue of AIDS contains a study led by Dr. Clayton Wiley of the University of Pittsburgh Medical Center. The post-mortem study involved 10 AIDS patients, some of whom had evidence of HIV-associated encephalitis. The researchers found that productive HIV infection of the brain monocytes, macrophages and microglia may play a role in the development of HIV-associated dementia complex. These results could lead to the development of better therapy in the future.

Study of Sex Differences in AIDS Care Launched. A new 48-week study announced at the National Conference on Women and HIV/AIDS will compare differences between the sexes in treating HIV. The trial, sponsored by Bristol-Myers Squibb and Merck & Co., will compare 100 women and 100 men who have had no success with current drug therapies. All participants in the study will have a peer advocate to help the patients stay in the trial and to follow the requirements. Factors to be studied include sex differences for viral load suppression, diabetes, abnormal body fat distribution and raised cholesterol levels.

Women Put at Risk by Secret Infidelity. Millions of American women wrongly think they are not at risk for contracting a sexually transmitted disease because their partners are supposedly monogamous, according to new research. A report from the Alan Guttmacher Institute in the journal Family Planning Perspectives reveals that almost 3.5 million women were wrong about a partner's faithfulness. In addition, many of the women who were aware that their partners were having sex with others did not require them to use condoms. The report, based on data from two surveys, also found that more than 75 percent of sexually active women and men reported having just one sexual partner in the past year.

NAACP Launches Campaign to Reduce AIDS in Blacks. The National Association for the Advancement of Colored People (NAACP) and a number of corporations plan to release a series of videos this week focusing on HIV and AIDS, including prevention methods and treatments. Three documentaries that run 30 to 60 minutes long will show powerful, graphic depictions of AIDS patients and the families of people who have died from the disease. Cable channels will air the videos nationally starting this month. The videos will also be distributed to churches, clinics and to the 2,200 branches of the NAACP. The videos, which will discuss how AIDS affects African Americans and women, feature statements from Surgeon General David Satcher, Rep. Maxine Walters (D-Calif.), author Maya Angelou, and NAACP officials Kweisi Mfume and Julian Bond.

National Groups Seek Better Access to Sterile Syringes. In an effort to prevent further transmission of blood-borne diseases, five major health organizations have called on state health leaders to work together to address the issue of access to sterile syringes. The American Medical Association, the American Pharmaceutical Association, the Association of State and Territorial Health Officials, the National Association of Boards of Pharmacy, and the National Alliance of State and Territorial AIDS Directors are also calling for joint state-level action to lower the legal and regulatory barriers that limit access to sterile syringes in most states. The U.S. Public Health Service said two years ago that drug users who continue to inject should use a new sterile syringe each time, with the most reliable source for obtaining the syringes being a pharmacist. The five health groups all have policies supporting that recommendation, and are encouraging changes to state laws and pharmacy regulations that currently make it hard for intravenous drug addicts to follow medical advice that sterile syringes be used only one time.

HIV-Positive Nurse Launches Needle Campaign. An American nurse spoke in Glasgow, Scotland, October 29, about the need for safe needles to prevent needlestick injuries. Lynda Arnold, who contracted HIV from an accidental needlestick at the hospital where she worked, was in Scotland to promote an effort by the health service union Unison to introduce safe needles. Jim Devine, the union's senior regional officer, asserted, "Every year, over 20,000 health service workers in Scotland are affected by needlestick injuries and as a consequence are putting their lives at risk because the Scottish health service uses outdated technology."

Economics Should Not Dictate Suboptimal AIDS Therapy. At the Fifth International Congress on AIDS in Asia and the Pacific, Dr. Chris Tsoukas, director of Montreal General Hospital in Quebec, spoke of the danger in compromising on highly active antiretroviral therapy for HIV patients. He discussed the need for potent therapy, without lowering the standard in poorer nations. Dr. David Butcher, medical director and assistant clinical professor of medicine at Chase Brexton Health Services in Baltimore, also noted that 80 percent of the original patients involved in a triple drug study in the United States still have undetectable viral loads after over three years of therapy.

UNAIDS Again Calls on Private Sector to Address AIDS in the Developing World. Officials with the Joint United Nations Program on HIV/AIDS see a great need for the private sector to help control the AIDS epidemic in developing nations. Three areas in which the private sector can help are implementing vertical transmission prevention programs, developing vaccines, and improving access to treatment. The HIV vaccine is one plan that needs continued investment for a long-term solution, UNAIDS said.

The Looming Threat of AIDS and HIV in Latin America. Latin America is seeing an increase in HIV cases, especially among women and children. At a conference in Ecuador this summer, participants were told that there are high rates of infection in countries including Brazil and Mexico, but the prevalence of HIV is low in other areas. Ecuador may see a substantial increase in cases as a result of changing demographics and the failure of the government to make AIDS a priority. According to official estimates, there are about 1,800 HIV infected individuals in Ecuador; however, AIDS groups say the actual number is closer to 20,000. Conference participants also heard that there is widespread underreporting in the country as a result of a government policy that requires health care workers to record both the names and addresses of individuals who test positive for HIV. The meeting was sponsored by the International HIV/AIDS Alliance and Glaxo Wellcome's Positive Action Program.

Online HIV Counseling Offered by Home Access Health. The first real-time online counseling services for people with concerns about HIV and the hepatitis C virus (HCV) are being made available via a joint effort from Home Access Health Corp. and FaceTime Communications. The confidential service, which can be accessed from the Home Access Health Internet site, will enable people to talk anonymously with a professional counselor at any time of the day. Home Access Health also manufactures the sole FDA-approved at-home test kits for HIV and HCV.

Ryan White Foundation Is Shutting Down. The Ryan White Foundation closed in October, the result of decreasing donations. Jeanne White-Ginder, the founder of the organization named for her son, who died nearly a decade ago after contracting HIV through contaminated blood-clotting products, said she now plans to join AIDS Action. There, she will lead a new project that aims to educate young people about HIV and to lobby for more federal funding for AIDS programs.

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This article was provided by AIDS Survival Project. It is a part of the publication Survival News.
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