Gay Men's Health Crisis: Treatment Issues - Volume 5 no. 4, May 15, 1991
Gabriel Torres, M.D.

Transmission

Approximately 300,000 new cases of hepatitis B are diagnosed per year [25]. Ten thousand of those cases require hospitalization. Six to ten percent of infected persons become chronic carriers and may infect others despite showing no signs of illness themselves. These numbers are unconscionably large given that HBV can be fairly easily prevented. HBV can be transmitted through contact with blood, semen, and saliva. Following the safer sex guidelines to prevent HIV transmission will help in avoiding HBV transmission as well, but those guidelines are not enough. It is important to note that because hepatitis B virus is more contagious than HIV, oral sex and deep kissing are much higher risk activities for the transmission of HBV. While, historically, homosexual men have had a higher prevalence of HBV infection than any other single group [26], the advent of safer sex practices among gay men has decreased the number of new cases among gay and bisexual men in this group. On the contrary cases attributable to heterosexual activity have increased 77% between 1982 and 1988 [27].

Protection by Vaccine

The best protection from Hepatitis B is by vaccination, which may be effective in 85-95% of cases. Two types of vaccines have been developed which have been shown to protect uninfected individuals. Heptavax-B is a vaccine derived from the plasma of HBV-infected persons. Recombivax is another vaccine, which is artificially produced from yeast through genetic engineering. One study shows that the plasma-derived vaccine may be superior in building antibodies against HBV in uninfected persons [28]. Though the vaccine is prepared from human blood, the method used to purify the product, kills all types of viruses found in blood, including HIV. No case of HIV infection from the vaccine has been reported.

The Hepatitis B vaccines are administered as injections. Usually three injections are given over a six-month period, followed by a yearly booster shot. The most common side effect of the vaccine is soreness in the arm, at the site of injection.

The Centers for Disease Control (CDC) is urging vaccination of the millions of people at risk for HBV infection. According to the CDC, these include infants, heterosexual men and women with multiple sex partners, health care workers, gay and bisexual men, intravenous drug users, and persons with occupations which put them in contact with blood and body fluids (i.e. firefighters, emergency personnel, and morticians.

HBV Infection in HIV

Hepatitis B has been shown to be a more severe disease in HIV-positive persons than in HIV-negative persons. HIV-infected persons may have the virus for a longer period of time, including more prolonged liver function test abnormalities and clinical illness. Additionally, HIV-positive people may be more likely to become HBV-carriers [29]. The duration of protection from the vaccine seems to also be shorter in HIV-seropositive people. In one study of hemophiliacs, all of the 67 HIV-negative, hemophiliac patients who were vaccinated, developed and maintained antibodies after 4 years. But five of 11 HIV-positive hemophiliac patients did not retain antibodies, when tested 4 years later [30].

Though the vaccine may be less effective in HIV seropositive persons, it is still advisable because such vaccination may result in protection from a severe and debilitating disease. It is unclear whether HIV-positive persons should receive extra boosters at yearly intervals to maintain the adequate antibody amounts for protection. However, levels of antibodies, should be checked routinely as part of regular health maintenance.

For antibody testing and immunization in New York contact Community Health Project at (212) 675-3559. The total cost of screening for Hepatitis B antibodies is $21.00. The cost the vaccine is free.

In Brief

Pentoxifylline To Be Tested: A drug, originally approved by the FDA to treat leg cramps from circulatory problems, has been shown to have anti-HIV activity in test tube and in other preclinical trials. Pentoxifylline, manufactured by Hoechst-Roussel Pharmaceuticals, Inc., under the name Trental, was found to lower levels of a natural body protein, called Tumor Necrosis Factor (TNF). TNF is thought to contribute to fever and wasting in cancer patients and may help fight similar TNF-related symptoms in patients with AIDS.

TNF is also known to increase reproduction of HIV, and recent test tube studies show that pentoxyfilline may also slow HIV in the human body. Researchers at the Community Research Initiative (CRI) in New York plan to begin human trials "starting anyday" with a 16-week, controlled study to determine safety and efficacy data of pentoxifylline. For more information, call (212) 481-1050.

In the meantime, Hoffman-La Roche is sponsoring a trial to determine the effect of pentoxifylline and antiviral drugs, AZT or ddC. The trial is being conducted at Beth Israel Hospital in Newark, New Jersey. Twenty-four male HIV- positive volunteers or non-pregnant, non-nursing female volunteers are being recruited. The trial offers a compensation of $1,500.00 at the completion of the study and includes some brief hospital stays.

A non-Burroughs AZT? Barr Laboratories, Inc. submitted an abbreviated New Drug Application (or an ANDA) to the FDA on March 19, 1991 for zidovudine (AZT) capsules, 100mg. The company, located in Pomona, New York, reported in a letter that the FDA acknowledged receipt of the ANDA and "made a threshold determination that [the application] is sufficiently complete to permit a substantive review." Generic drug products, like Barr's version of AZT may foster public policy by making affordable AZT available to the AIDS community. The legistlation defines approval time as 180 days. Mark your calendars.

Clarification: Colposcopy and anascopy are reimbursable by medicaid in New York and New Jersey when used as diagnostic procedures (i.e., when smears indicate that abnormal or cancerous growths are present). They not reimbursable when used as screening procedures, which some professionals recommend and, as recent studies indicate, may detect abnormal growths in HIV-infected individuals much more acurately.

New Studies

Treatment for Psoriasis: The New York University Department of Dermatology is beginning a study of treatment for HIV-associated psoriasis. Psoriasis is a skin condition, consisting of a rash of raised bumps and sometimes a thick silvery scale, which can be partiuclarly severe in people with HIV illness [See Treatment Issues Vol.4, No.8.] Trial participants will be required to have a physical examination by a physician at Bellevue Hospital, Tisch Hospital, or Manhattan VA Medical Center with skin biopsies and blood tests. During the first seven weeks of the study, participants will be treated with Ultra Violet B (UVB) phototherapy three times a week. UVB is a concentration of sunlight, similar to that used in tanning salons, but much stronger. For more information contact Janet A. Moy, M.D. or Miguel Sanchez, M.D. at (212) 263-6484 or (212) 561-3115.

Clindamycin Dropped from Toxo Trial. The Toxoplasmosis Prophylaxis Study sponsored by the Community Programs for Clinical Research on AIDS (CPCRA) reported in Treatment Issues Vol. 5, No.3 has been changed. The clindamycin arm has been dropped from the trial because the drug has been causing rashes and diarrhea. The trial is continuing with pyrimethamine vs. placebo. For more information contact the Newark Community Health Centers in New Jersey at (201) 565-0355 or (201) 483-1300.

566c80 at Harlem Hospital. The Harlem AIDS Treatment Group at Harlem Hospital Center is conducting a trial with the drug 566c80 for people with toxoplasmosis, who are either failing or intolerant to standard therapy.. For more information call Andrew Masterson at (212) 694-4033.

CD4 Trial Still Recruiting. Columbia Presbyterian Medical Center is running a trial for HIV-positive patients with T cell counts under 300, on AZT (500 or 600 mg per day) to receive soluble CD4 for six months. CD4 is thought to block HIV from infecting cells [see Treatment Issues Vol 4 No.5]. Participants will learn to give themselves injections three times a day. Phase I studies have shown no toxicity and minimal side effects. For additional information call Dr. Jay Dobkin at (212) 305-8507.

Treatment Issues is GMHC's newsletter devoted to providing reliable information on experimental AIDS therapies. Describing an experimental therapy should not be construed as recommending it. All new treatments should be done under a physician's care.

References:

25. NIAID. National forum addresses AIDS and hepatitis B. The Double Helix 13:Spec Conf issue, January 1989. 26. Ma P et al. AIDS and Infection of Homosexual Men: Second Edition. Buttersworth Publishers, 1989. 27. Hadler SC et al. Outcome of Hepatitis B virus infection in homosexual men and its relation to prior HIV infection. J Infect Dis 163:454-459, 1991. 28. Odaka N et al. Comparative Immunogenicity of Plasma and Recombinant Hepatitis B virus vaccines in homosexual men. JAMA 260:3635-3637, 1988. 29. Alter MJ et al. The changing epidemiology of Hepatitis in the United States. JAMA 9:1218-1222, 1990. 30. Mannucci PM et al. Longterm immunogenicity of a Plasma-derived Hepatitis B vaccine in HIV seropositive and HIV seronegative hemophiliacs. Arch Intern Med 149:1333-1337, 1989.

Copyright 1991 Gay Men's Health Crisis, Inc. All rights reserved. Non-commercial reproduction is encouraged. Distributed by AEGIS, your online gateway to a world of people, knowledge, and resources. Direct Dial: v.34+: 714.248.2836; v.120/ISDN: 714.248.0433 Internet: telnet:aegis.com www: www.aegis.com

910515
GM050404

Copyright © 1991 - Treatment Issues. Reproduced with permission. Treatment Issues is published twelve times yearly by GMHC, Inc. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. GMHC Treatment Issues, The Tisch Building, 119 West 24th Street, New York, NY 10011  fredg@gmhc.org  http://www.gmhc.org

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .