Based on their results, the authors emphasized the need to counsel women about the possible increase in HIV risk with hormonal contraceptive use, especially the shot Depo-Provera, and the importance of condom use to decrease risk of HIV.

“Women should be counseled about potentially increased risk of HIV acquisition and transmission with hormonal contraception, particularly injectable methods, and about the importance of dual protection with condoms to decrease HIV risk,” said Renee Heffron, a researcher at the International Clinical Research Center at the University of Washington and lead author of the study, in a press release.

The researchers advocated further studies of other hormonal contraceptives, such as implants or patches, to determine whether they also affect HIV acquisition and transmission risk. They also argued that contraceptive counseling should be combined with HIV counseling and testing.

The results were first presented in July at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention in Rome.

According to the study authors, the prevention of unintended pregnancy in women with or at risk for HIV has benefits that include reduced mother-to-child transmission of HIV and improved health of children through spacing of pregnancies.

Many women throughout the world use hormonal birth control, which includes birth control pills and injected contraceptives such as Depo-Provera (depot medroxyprogesterone acetate). However, the effects of hormonal contraception on HIV risk are unclear; according to the authors, some studies have investigated the association between hormonal birth control and the risk of HIV acquisition and transmission but results have been conflicting.

In this study, researchers followed nearly 3,800 serodiscordant couples in seven African countries from 2004 to 2010. Serodiscordant couples are couples in which one partner is HIV-positive and the other partner is HIV-negative.  In most of the couples in this study, the partner infected with HIV was female.

All participants were aged 18 years or older, were sexually active, and were not using antiretroviral therapy. Additionally, all HIV-positive partners in the trial had herpes simplex virus type 2.

The researchers monitored rates of HIV-acquisition by HIV-negative women taking oral hormonal contraceptives or who received Depo-Provera shots. They also monitored rates of HIV-transmission from HIV-positive women taking hormonal contraceptives to their HIV-negative male partners.

All participants received HIV-prevention services, including counseling, free condoms, and treatment for sexually transmitted infections.

Results showed that HIV-negative women who used hormonal contraception, either in pill form or injected, were twice as likely to contract HIV from their HIV-positive male partners as women who reported using other forms of birth control or no birth control.

In addition, HIV-positive women who used hormonal contraception were twice as likely to transmit the virus to their uninfected partners as women who did not.

However, the study authors noted that not enough women in the study used birth control pills (rather than Depo-Provera) to draw definitive conclusions about the pill form of contraceptives.

The study authors also found that women using Depo-Provera had higher levels of HIV in the genital tract, even though the levels of HIV in their blood were the same. The researchers suggested that the higher level of HIV in the female genital tract might be a mechanism for increased risk of HIV transmission.

The researchers stated that a randomized trial is needed to definitively establish the risk of HIV associated with the contraceptives since the current study did not take into account factors such as contraception adherence and brand of contraception used.

For more information, please see the article in The Lancet Infectious Diseases (abstract) or the press release from the University of Washington.

The authors of the review also found that hormonal contraceptives remain a popular choice for women with HIV and are also a good option, if used with condoms and if adjusted for potential interactions with antiretroviral therapy.

They added that hormonal contraceptives and intrauterine devices should always be combined with regular condom use, since the use of hormonal contraceptives and intrauterine devices alone cannot prevent transmission of HIV or other sexually transmitted diseases.

Due to the complexity of antiretroviral regimens and the possible effects of antiretrovirals on fetal development, the authors of the review also recommended that women receive counseling for pre-conception planning in the event that they do decide to have a child.

In the United States, women account for around a quarter to a third of the HIV-positive population. The majority of infected women are of childbearing age.

Since many HIV-positive women will consider having children at some point, many choose to use non-permanent methods of contraception. A variety of contraceptive options are currently available to women. However, all of them have both advantages and disadvantages with regard to conception and HIV transmission prevention.

Condoms And Diaphragms

The authors of the review noted that condoms are still the most effective contraception option for reducing the risk of HIV transmission. The risk of transferring infection is reduced by 95 percent when condoms are used.

However, the condom failure rate can be as high as 14 percent over the first year of use, leading many women to look at alternative or supplementary methods. Additionally, condom usage relies on cooperation between both partners, which can sometimes be an issue.

An alternative to condoms for men are female condoms, which are reported to be as effective as the male condom. However, there is a greater chance of error in using female condoms, and the failure rate of pregnancy can be as high as 26 percent during the first year of use. Another barrier to the female condom is a higher cost and lower availability compared to the male condom.

Another alternative is a diaphragm, a thin rubber cup that is placed over the cervix. Some women prefer diaphragms because, unlike a condom, they can be used discreetly, without informing a partner. However, diaphragms have a failure rate of 13 to 17 percent and also leave a large portion of the vaginal surface uncovered, which means they may not be effective at preventing HIV transmission.

Hormonal Contraceptives

Hormonal contraceptives, which include oral contraceptives (birth control pills), contraceptive patches (e.g., OrthoEvra), Depo-Provera (depot medroxyprogesterone acetate), contraceptive rings (e.g., NuvaRing), and contraceptive implants (e.g., Implanon), provide the best protection against pregnancy. Typical failure rates range from 0.3 percent to 5 percent per year.

However, these methods provide no protection against HIV transmission or other sexually transmitted diseases. Additionally, some hormonal contraceptives may interact with antiretroviral treatment, making them less effective at preventing pregnancy.

Oral contraceptives, or birth control pills, are a very popular choice. When taken as prescribed, they have a failure rate of about 0.1 percent per year; in actual practice, their failure rate is about 5 percent per year.

However, oral contraceptives are not as effective in women taking certain antiretroviral drugs. Some antiretroviral medications affect the liver enzymes that metabolize the contraceptives, lowering the amount of the contraceptives in the bloodstream and making them more likely to fail.

In particular, protease inhibitors and non-nucleoside reverse transcriptase inhibitors are common types of anti-HIV medications that can affect oral contraception activity.

The review authors noted that physicians usually assume that antiretrovirals also reduce the efficacy of other hormonal contraceptive types, including patches, rings, and implants, but that more data is needed to confirm whether this is the case.

One option to mediate this problem, according to the review authors, is to take high-dose contraceptives – for example, oral contraceptives with at least 30 to 50 micrograms of estrogen. However, this may also increase the risk of blood clots or strokes, so the authors suggested that women should undergo a comprehensive medical assessment first to identify any risk factors for these conditions.

Depo-Provera is another popular option for HIV-positive women. Depo-Provera, a synthetic progesterone contraceptive that is administered as a shot every three months, has no known drug interactions with antiretroviral therapy. Depo-Provera has an estimated 0.3 percent failure rate for pregnancy.

However, some disadvantages include effects on the menstrual cycle that some women find undesirable; effects on bone calcium storage that may cause irreversible bone loss, which is already a severe problem in HIV-positive individuals on antiretroviral therapy; and a long window for restoration of fertility after Depo-Provera is stopped, usually 9 to 10 months.

Finally, like other hormonal contraceptives, Depo-Provera does not prevent HIV transmission.

Intrauterine Devices

Intrauterine devices (Mirena or Paragard) are small plastic devices that are inserted into the uterus to prevent pregnancy. They usually are used for long-term contraception, often 5 to 10 years at a time, with failure rates of 0.1 to 0.6 percent or less.

According to the review authors, these are considered safe, convenient and effective methods of contraception for HIV-positive women. Additionally, there is no data suggesting that intrauterine devices interact with antiretroviral therapy.

As a result, the authors suggested intrauterine devices are likely an optimal choice for HIV-positive women for pregnancy prevention, although they acknowledged that many women feel more comfortable with hormonal contraceptives.

Like hormonal contraceptives, intrauterine devices do not prevent transmission of HIV.

For more information, please see the review in the Journal of the Association of Nurses in AIDS Care (abstract).

This has been a disappointing finding for researchers and has likely brought an end to further research in this particular product.

PR0 2000 is a vaginal microbicide, which is a substance whose purpose is to reduce the infectivity of viruses. As of now, there are no microbicides that have been effective against HIV infection.

PRO 2000 is designed to be used by women before sexual intercourse, because it was previously believed to reduce the risk of contracting the HIV infection.

Researchers placed high expectations on this product, in hopes that it would provide a safe preventive option for women and help to decrease the amount of infections in Africa.

The placebo-controlled trial involved 9,835 women from four different African countries. This trial was a conducted on a larger scale, in order to check the validity of positive results from a previous smaller clinical trial conducted by the U.S. National Institutes of Health.

“This result is disheartening, particularly in light of the results of the smaller trial,” stated the study’s chief investigator, Dr. Sheena McCormack of the Medical Research Council, in a press release.

“Nevertheless, we know that this is an important result and it clearly shows the need to undertake trials which are large enough to provide definitive evidence for whether a product works.”

With these findings, other research on similar types of HIV preventive gel may also prove to be ineffective (see related AIDS Beacon news).

Clinical trials are also currently being conducted to evaluate the effectiveness of different types of HIV preventive methods for women (see related AIDS Beacon news).

For more information, please see Microbicides Development Programme’s press release.

These 97 medications include 23 vaccines and 54 antiviral drugs, all of which are currently in clinical trials or waiting for FDA approval.

“We are greatly encouraged by these critically important medicines and vaccines in development to treat and prevent HIV infection,” said Billy Tauzin, President and CEO of PhRMA, in a press release.

Among the drugs currently on the list provided by PhRMA is Intelence (etravirine), which has now been granted approval by the FDA for use in treatment experienced patients.

Intelence is a non-nucleoside reverse transcriptase inhibitor (NNRTI), which is a class of antiretroviral drugs that inhibit the action of reverse transcriptase, an enzyme in the body that helps copy the genetic material of HIV into the DNA of human white blood cells.

Intelence is especially important for treatment experienced patients who have exhibited resistance to other NNRTIs and antiretroviral medications, as it is specifically targeted towards helping this group of patients.

Since HIV was first discovered in the 1980’s, thirty-one drugs have been approved to fight the disease.

According to Tauzin, “the new medicines our scientists are working on right now bring hope for even more promising results in the future.”

Another important drug included on the PhRMA report is dapivirine, which is being tested for prevention of HIV transmission in women.

The drug comes in the form of a vaginal gel, and if incorporated into intravaginal rings, it could prove to be much more effective than traditional microbicides.

Past research regarding HIV transmission has also focused on intravaginal rings and vaginal gels for use by women (see related Beacon News).

Vaginal rings have been previously used by women to prevent pregnancy; however, recent research has explored including anti-HIV chemicals into the ring that interrupt stages in the HIV life cycle to prevent it from replicating.

With approximately 33 million people living with HIV worldwide, and many in countries where access to medical care is scarce, developing treatment options that are globally viable is important.

There have been several previous ventures focused on addressing international HIV and AIDS needs, such as Viiv Healthcare, a joint venture between the pharmaceutical companies GlaxoSmithKline and Pfizer (see related Beacon News).

Such collaborations have emphasized reducing discrimination related to HIV and AIDS, as well as increasing worldwide access to medical care.

For more information, please see the PhRMA Web site.

The second generation FC2 Female Condom is composed of nitrile, a synthetic rubber polymer, whereas the first generation FC1 Female Condom is composed of polyurethane.

Through various research studies, it was determined that nitrile can be manufactured with a less expensive process and still provide the same amount of protection as polyurethane. This change in manufacturing has helped FHC reduce the cost of FC2 by 30 percent as compared to FC1, allowing for overall price reductions.

The FHC focused on the development of FC2 in order to spread affordable access to the only female prevention product currently available for protection from HIV.

“It is important to find cost-effective ways to ensure access to safe and effective HIV prevention,” said Dr. Monica Sweeney, Assistant Commissioner of the Health Department’s Bureau of HIV/AIDS Prevention and Control, in a press release. “The new FDA-approved female condom will expand access to woman-initiated HIV and STI prevention, and it will help us make continued progress in reducing NYC’s HIV infection rate.”

Currently, NYC is the nation’s largest FC1 female condom distributor. With the introduction of FC2, there is potential for improvement in NYC’s HIV prevention efforts.

Internationally, FC2 has been available since 2005. Currently, more than 90 countries have been distributing it through their national HIV prevention programs. In the fiscal year 2008, nearly 35 million units of FC female condoms (FC1 and FC2) were distributed worldwide.

The FC female condom is the only FDA approved female-initiated method of HIV prevention. The female condom provides women and men with an alternative method of HIV prevention when a partner refuses to wear a male condom.

One of the main contributing factors to the limited use and spread of FC female condoms is the high cost. With the introduction of the less expensive FC2, women will have increased access to a cost-effective prevention method.

Another contributing factor is the lack of education and awareness of the product. Malawi, Zambia, and Zimbabwe recently became the first countries to increase distribution through programs that educate women about how to use female condoms and how to discuss it with their partners.

In an effort to introduce and spread awareness of FC2 in NYC, the FHC has plans to hold a one-day education seminar for women currently using FC1.

For more information, please see the press release from Female Health Company.