|
U.S.
Food and Drug Administration |
This article originally appeared in the October 1993 FDA Consumer. The version below is from a reprint of the original article and contains revisions made in September 1995 and September 1997. Additional sources of AIDS information are listed at the end of the article. |
Infections with HIV, the virus that causes AIDS, have been rising faster in women than in men. The percentage of female infected adults and adolescents increased steadily, from 7 percent in 1985 to 18 percent in 1995. And although total deaths from AIDS declined by 12 percent overall in the first half of 1996, deaths among women with AIDS rose by 3 percent during the same period.
The disease disproportionately affects minority women. Although African-American and Hispanic women make up 21 percent of the country's female population, they account for about 75 percent of women diagnosed with AIDS. This does not mean that a person is at risk simply by being a member of a racial or ethnic minority group; rather, it reflects the higher numbers of minority populations in communities with a high incidence of HIV infection.
In this country, most women who now have AIDS became infected with HIV by injecting illegal drugs. But the rate of infection through heterosexual transmission has been rising dramatically. Of 13,996 women whose AIDS cases were reported between July 1995 and June 1996, 36 percent were infected through injection drug use and 40 percent through sex.
The Centers for Disease Control and Prevention reports that, "Many women in the United States are unaware they are at risk for HIV infection, and HIV-infected women often remain undiagnosed until the onset of AIDS or until a perinatally infected child [infected before or during birth] becomes ill."
What You Don't Know Can Hurt You
A woman may not realize she is at risk for HIV. For example, she may not know her sex partner uses or has used intravenous drugs or is bisexual or has had at-risk sex partners in the past. She may disregard symptoms that could serve as warning signals and therefore, not seek testing or treatment.
"Delayed diagnosis affects survival," says Theresa Toigo, associate commissioner for the Office of Special Health Issues in the Food and Drug Administration. "The late diagnosis of women has contributed to past reports that women's survival time is shorter than men's. It's not." If a woman is diagnosed at the same point in the disease as a man, her survival is, on the average, the same. But most HIV-infected women are from poor populations with poor access to health care, whereas many men with HIV are more affluent gay men from areas with better medical resources.
"Probably the biggest contribution that can be made to the survival of someone with HIV is to get them into early treatment," says Toigo.
Based on experience with the gay male population, it appears that education and awareness are important in stemming the tide of HIV infection. Early in the AIDS epidemic, gay men--who were then the hardest hit group--organized and conducted an extensive education program that proved effective in bringing many gay men into clinics for testing and treatment.
Federal, state, local, and nongovernment agencies are working together and individually to step up prevention efforts, improve diagnostic and treatment services, and establish community-based health education and risk-reduction programs for diverse populations, including gay and bisexual men, prostitutes, injection drug users, heterosexuals with multiple sex partners, women at risk, homeless people, and youth in high-risk situations, such as runaways and youngsters in shelters or detention centers. President Clinton in 1993 established the Office of AIDS Policy to coordinate all federal-level efforts against the epidemic. In addition, the National Task Force on AIDS Drug Development was established by the Secretary of Department of Health and Human Services to identify barriers to the rapid development of therapies for the treatment of AIDS. The task force has provided an opportunity for members of affected communities, the pharmaceutical industry, academia, and government agencies to engage in frank discussions about removing obstacles to AIDS drug development. These discussions have been reinforced by the President's Summit on AIDS in December of 1995 and subsequent meetings of the President's Advisory Council on AIDS, as well as Vice President Gore's meetings with the pharmaceutical industry.
It's expected that FDA's approval in 1996 of two blood tests will result in earlier diagnosis of HIV infection, especially among women and minorities. A home test kit, available over the counter, enables a person to obtain a blood sample at home and then send it, with identity protected, to a lab for analysis. Counseling is provided as part of the test system. Orasure Western blot is a laboratory test that doesn't require a blood sample. Rather, it requires a tissue sample that can be collected from between the gum and cheek.
Drug Labels Provide Warning
To help increase awareness about the most common early indicator of HIV infection in women--recurrent vaginal candidiasis (yeast infections)--FDA in October 1992 required manufacturers of over-the-counter drugs for these infections to include a new label warning on their products.
The warning states that frequent vaginal yeast infections (recurring within a two-month period)--especially those that don't clear up easily with proper treatment--may be the result of serious medical conditions, including HIV infection, and advises women with these symptoms to see their doctors. (Recurrent yeast infections also may result from hormonal changes or use of oral contraceptives or antibiotics, as the label already noted.) Examples of over-the-counter preparations that must carry these warnings are Monistat-7 (miconazole nitrate); Gyne-Lotrimin, Mycelex-7, and FemCare (clotrimazole); Femstat 3 (butoconazole nitrate); and generic versions of these products. Manufacturers of oil-containing or oil-based vaginal creams for treating yeast infections and other vaginal infections must also warn patients not to rely on latex barrier contraceptives, such as latex condoms or diaphragms, when using their products. The cream may cause the latex to weaken or break.
Other illnesses and infections in women that should prompt concern about possible HIV infection include pelvic inflammatory disease (PID), cervical dysplasia (precancerous changes in the cervix), yeast infections of the mouth and throat, and any sexually transmitted disease, such as genital ulcers and warts and herpes infection.
In February 1995, FDA published a proposed rule in the Federal Register to require manufacturers of over-the-counter spermicides to submit data showing their products are effective as contraceptives. The agency also strongly encouraged manufacturers to evaluate these products for prevention of sexually transmitted diseases, including HIV. Though the administrative record for this rule originally closed on April 3, 1996, after discussions with industry, FDA reopened the record, with the comment period ending March 3, 1997.
AIDS Definition Revised
A doctor diagnoses AIDS when an HIV-infected person develops one of several infections or diseases specified by CDC in its "AIDS surveillance case definition." These illnesses include PCP (Pneumocystis carinii pneumonia), Kaposi's sarcoma (a type of cancer), toxoplasmosis, and others. As knowledge about HIV and AIDS has grown over the years, CDC has expanded its definition to include additional AIDS-defining illnesses. In January 1993, CDC added cervical cancer, along with pulmonary tuberculosis and recurrent pneumonia, to the list of AIDS-indicator illnesses in HIV-infected people.
The revised AIDS definition also includes all HIV-infected people with severe CD4 cell depletion (less than 200 CD4 cells per cubic millimeter). CD4 cells are critical immune system cells that number from about 800 to 1,000 in a healthy person.
According to the earlier definition, a person with a very low CD4 count but no AIDS-defining illness was not included in the case definition of AIDS.
Treatment
Available data suggest that drugs used to treat HIV work similarly in men and women. These drugs are usually grouped by the way they fight the virus. When this special issue went to press, approved agents included:
Reverse Transcriptase Inhibitors:
The AIDS Clinical Trials Information Service (ACTIS) can provide current information on federally and privately sponsored HIV and AIDS drug and vaccine clinical trials, free customized searches of national clinical trials and drug databases, and confidential, personalized assistance from English- and Spanish-speaking health specialists. (See "Information Sources.")
Certain infections may be more severe or prolonged or occur more frequently in people with HIV infection, and so may require different forms of therapy. For example, some doctors may prescribe oral antifungals for vaginal yeast infections in HIV-infected women instead of the commonly used vaginal products.
Similarly, PID, syphilis, gonorrhea, and genital warts may be harder to treat in HIV-infected women. PID, which normally produces fever and pain, may go unnoticed in an HIV-infected woman because her body hasn't been able to mount the immune response that causes these symptoms. Therefore, her infection may worsen for quite some time before she gets medical help.
Syphilis, effectively treated with penicillin in an otherwise healthy woman, may require higher doses or different drugs and have a lower cure rate in an HIV-infected person. Genital warts, which are associated with cervical cancer and obstruction of the urinary bladder, may require laser surgery.
Cervical dysplasia, too, can lead to cervical cancer. In HIV-infected women, cervical dysplasia appears to be more common and may progress more quickly to cervical cancer than in uninfected women. For these reasons the American College of Obstetrics and Gynecology and most practitioners recommend that women with HIV have Pap tests twice a year to make sure cancer is detected and treated early.
The federal government, in June 1997, recommended that all people with AIDS receive a combination treatment of three antiviral drugs, including one protease inhibitor. It also recommended that most people with early HIV infection also receive the combination therapy.
Prevention
Armed with knowledge about risks and prevention, women can do much to protect themselves from HIV infection. According to CDC, as of December 1995, about half of all reported cases of AIDS in adult and adolescent women were due to injection drug use, and about another third resulted from heterosexual transmission. Transfusion of blood or blood products accounted for another 5 percent.
The risk of transmission of HIV from transfused blood has been substantially reduced since 1985, due to the HIV-1 antibody and antigen test kits to screen blood donors for HIV-1. Antigens, which are the virus' own proteins, can be detected about a week earlier than antibodies. In addition, blood products used to treat hemophilia have been treated with cryoprecipitate.
The most important risks for women are using injection drugs, having unprotected sex with someone who uses or has used injection drugs, and having unprotected sex with a man who has had sex with another man. Having multiple sex partners also increases risk of infection.
Safer Sex
In the United States, the odds of a woman becoming infected from a man are much greater than the reverse. In one recent study of 379 couples, researchers found a 1 percent rate of female-to-male transmission of HIV, compared with a 20 percent rate of male-to-female transmission.
"The surest way to protect yourself against HIV infection and other STDs is not to have sex at all, or to have sex only with one steady, uninfected partner," states the Surgeon General's 1993 report on HIV infection and AIDS. The following advice for women who are not in such a relationship and engage in sex:
Even women infected with HIV should have their partners use a condom to protect themselves from infection by other sexually transmitted viruses or bacteria and to help protect against infection from another strain of HIV. Many researchers believe that infections with more than one strain of HIV may lead to more rapid progression of disease or to introduction of resistant forms of the virus.
Do not rely on other forms of contraception for protection against HIV.
In April 1993, FDA announced that birth control pills, implantable contraceptives such as Norplant, injectable contraceptives such as Depo-Provera, IUDs, and natural membrane condoms must carry labeling that states these products are intended to prevent pregnancy but do not protect against HIV infection and other STDs. FDA has approved the marketing of male condoms made of polyurethane as effective in preventing STDs, including HIV. The polyurethane condom is an alternative for individuals allergic to latex.
The Reality Female Condom, made from polyurethane, may afford some protection against STDs, but it is not as effective as latex condoms for men. In approving the device, FDA required the labeling to indicate that for "highly effective protection" against STDs, it is important to use latex condoms for men. The male and female condom cannot be used at the same time. If used together, both products will not stay in place.
In addition, there is no evidence that diaphragms, or spermicides protect against HIV transmission.
Drug Use
Any illegal drug use puts a person at risk for HIV. An HIV-infected person who uses injection drugs and shares needles can pass the virus to someone else through tiny amounts of blood that remain in the needle or syringe.
Women who use non-injection drugs, especially crack and other forms of cocaine, also increase their risk for HIV because they may engage in risky sexual activity. Drug and alcohol use may cause a person to be less careful about choice of sex partners or to neglect to use a condom.
The Surgeon General's report advises:
AIDS and other illnesses due to HIV infection are the fourth leading cause of death in American women aged 25 to 44. In New York and New Jersey, it's the number one cause of death for women in this age group.
"FDA is concerned about this trend," says Toigo. The agency is meeting with women's groups, professional groups, and activists representing women with AIDS in cities and rural areas, among minorities and underserved populations.
The meetings provide a forum for the agency to hear the concerns of those in the trenches and work with the groups to try to contain an epidemic that is increasingly affecting women, especially among minorities.
Marian Segal is a member of FDA's public affairs staff. Judith Levine Willis also contributed to this article.
No one is certain when viral transmission occurs. Possibilities include: during childbirth, from exposure to maternal blood or vaginal fluids; or earlier in pregnancy, when there may be a mixing of blood or passage of the virus across the placental wall.
In August 1994, FDA approved Retrovir (zidovudine, or AZT) for use in preventing transmission of HIV from infected pregnant women to their babies. Approval was based on results of a federally sponsored study showing that the risk of transmission to newborns from infected mothers is significantly reduced in women receiving zidovudine during pregnancy. Since its approval, AZT has been observed to reduce HIV transmission to infants from 25 percent in untreated mothers to 8 percent in those treated with AZT.
In response to reports of a study suggesting that very high daily doses of AZT increased certain types of cancer in baby mice, an independent NIH advisory panel unanimously agreed in January 1997 that the benefits of HIV-infected pregnant women taking AZT outweigh the theoretical concerns raised by the study. There are no reports of any human child developing cancer after AZT treatment and it is unclear whether the mouse study results apply to humans. The committee also recommended that pregnant HIV-infected women be told about the study before being given the drug and emphasized the need for careful long-term follow-up of all children born to pregnant women who received AZT.
To gain the most benefit from AZT therapy, women need to be diagnosed early in the course of their infection and before or early in the pregnancy. To this end, the Public Health Service recommended HIV counseling and voluntary testing of all pregnant women in the United States.
Apart from the timing of transmission, studies suggest that the likelihood of the child becoming infected may correlate with the mother's health during the pregnancy or birth. In the June 9, 1993, Journal of the American Medical Association, Michael E. St. Louis, M.D., and his colleagues reported that a baby is more likely to become infected if the mother is in the very earliest stage of infection (when the virus is thought to be abundant) or in an advanced stage of disease, or if the membrane surrounding the placenta is inflamed.
A child can also become infected after birth through breast-feeding.
The national Centers for Disease Control and Prevention had received reports of more than 6,000 cases of AIDS in children infected before or during birth or through breast-feeding, as of Dec. 31, 1995. Not surprisingly, experts predict that as more women of childbearing age become infected, the number of infected children will also rise. A disturbing prospect under any circumstances, the significance of this projection is most poignant for minorities in New York City, where AIDS is already the leading cause of death in Hispanic children 1 to 4 years of age and the second leading cause of death for African American children of the same ages.
--M.S.
English service
1-800-342-AIDS (2347)
(7 days a week, 24 hours a day)
Spanish service
1-800-344-7432
(7 days a week, 8 a.m. to 2 a.m.
Eastern time)
TDD service for the deaf
1-800-243-7889
(Monday through Friday, 10 a.m.
to 10 p.m. Eastern time)
CDC
National AIDS Clearinghouse
1-800-458-5231
P.O. Box 6003
Rockville, MD 20849-6003
TTY/TDD
1-800-243-7012
(Monday through Friday, 9 a.m.
to 7 p.m. Eastern time)
HIV
AIDS Treatment Information Service
1-800-448-0440
P.O. Box 6303
Rockville, MD 20849-6303
TDD service for the deaf
1-800-243-7012
(Monday through Friday, 9 a.m.
to 7 p.m. Eastern time)
National Institute
on Drug Abuse Hotline
English service
1-800-662-HELP (4357)
Spanish service
(1-800) 66-AYUDA (662-9832)
For a copy of the 1993 Surgeon General's Report to the American Public on HIV Infection and AIDS, call 1-800-342-AIDS.
Publication No. (FDA) 95-1211
Table of Contents | How to Subscribe | Back Issues | FDA Home Page
FDA/Office
of Public Affairs
Web page last updated by clb
1999-FEB-19.