FDA Approves First Medication to Reduce HIV Risk

People diagnosed with HIV—the human immunodeficiency virus that without treatment develops into AIDS—take antiviral medications to control the infection that attacks their immune system.

Now, for the first time, adults who do not have HIV but are at risk of becoming infected can take a medication to reduce the risk of sexual transmission of the virus. The Food and Drug Administration (FDA) has approved the new use of Truvada—to be taken once daily and used in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. (HIV-1 is the most common form of HIV.) In two large clinical trials, daily use of Truvada was shown to significantly reduce the risk of HIV infection by 42 percent in a study sponsored by the National Institutes of Health (NIH) of about 2,500 HIV-negative gay and bisexual men and transgender women, and by 75 percent in a study sponsored by the University of Washington of about 4,800 heterosexual couples in which one partner was HIV positive and the other was not. Debra Birnkrant, M.D., director of the Division of Antiviral Products at FDA, explains that Truvada works to prevent HIV from establishing itself and multiplying in the body. She notes that while this is a new approved use, Truvada is not a new product. It was approved by FDA in 2004 for use in combination with other medications to treat HIV-infected adults and children over 12 years old. “In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time,” Birnkrant says. “
But it is still better to prevent HIV than to treat a life-long infection of HIV,” she says.
Birnkrant stresses that Truvada is meant to be used as part of a comprehensive HIV prevention plan that includes consistent and correct condom use, risk reduction counseling, regular HIV testing, and treatment of any other sexually-transmitted infections. Truvada is not a substitute for safer sex practices, she says. back to top

  Person Must Be HIV Negative Truvada, produced by Gilead Sciences Inc., is a combination of two antiretroviral medications used to treat HIV—tenofovir disoproxil fumarate and emtricitabine. When Truvada is used as a treatment for HIV rather than a preventive, the patient also takes a third drug, Birnkrant says. Which of the other approved HIV drugs is added depends on the needs of the patient. Before this medicine is prescribed, Birnkrant says there are several factors that a person and his or her health care professional must consider in weighing the risk versus the benefit: The person must be tested to ensure that he or she is HIV negative. Flu-like symptoms—such as fever or muscle aches—are a red flag because they could indicate the presence of early, acute HIV infection, even if test results are negative. There is a window of four to five weeks with some tests, and up to three months with others, in which the antibodies that indicate HIV infection do not appear in the blood. Safety concerns tied to Truvada have to do with its effect on the bones and kidneys. While effects observed in clinical trials were mild and reversible with discontinuation of the medication, people with a history of bone or kidney ailments should be regularly monitored to ensure their continued health. It is recommended that the person also be tested for hepatitis B because worsening of hepatitis B infections has been reported in those who have both HIV-1 and hepatitis B when treatment with Truvada was stopped. back to top Infection Rates Unchanged To help prescribers and other health care professionals advise uninfected people considering taking Truvada, the medicine is being approved with a Risk Evaluation and Mitigation Strategy (REMS). The goals of the REMS are to inform prescribers and potential users of Truvada of the importance of taking the medication every day, the importance of regular HIV testing and the importance of using Truvada in combination with other measures known to reduce the risk of HIV infection. As part of the REMS, a voluntary training and education plan will be made available to potential prescribers. This program includes a medication guide and safety brochure for the prospective Truvada users that would detail the risks, recommended screening tests and key information to share with a health care professional. About 1.2 million Americans have HIV. The body’s immune system is devastated by AIDS, leaving those who have it vulnerable to deadly infections. Each year, about 50,000 adults and adolescents in the U.S. are newly diagnosed with HIV. The overall rate of HIV infection has remained stable at least since 2004. “The rates of new HIV infections have not significantly changed for a long time,” says Birnkrant. “From FDA’s standpoint, this is not acceptable for a serious disease.” This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

drug on hiv approved drugs by fda for hiv

smaller medium larger FDA Approves First Drug for HIV Prevention Truvada Approved for HIV-Negative People at High Risk of Infection By Daniel J. DeNoon WebMD Health News Latest HIV News FDA Approves First Drug for HIV Prevention Studies Show Value of AIDS Drugs as Prevention First Over-the-Counter HIV Test Approved Wednesday Is National HIV Testing Day Bacterial Vaginosis Increases Female-to-Male HIV Want More News? Sign Up for MedicineNet Newsletters! Reviewed by Louise Chang, MD July 16, 2012 -- The FDA has approved use of the HIV drug Truvada to help people at high risk avoid infection with the AIDS virus. Truvada is already approved as part of treatment regimens for people with HIV infection. But this is the first time the FDA has approved any drug for "pre-exposure prophylaxis" or PrEP -- that is, for protecting uninfected people against HIV. It is not a prescription to party, says Debra Birnkrant, MD, the FDA's director of antiviral products. "We stress that PrEP with Truvada must include safer-sex practices, counseling, and HIV testing," Birnkrant said at a news conference held to announce the decision. "Truvada should not be used alone for HIV prevention." Two major studies suggest that PrEP with Truvada may work as hoped: In the iPrEx study of 2,499 HIV-negative men and transgender women who have high-risk sex with men, those who took Truvada had 42% fewer HIV infections than those who did not. There was no evidence that taking Truvada increased unsafe sex, although study participants did not know for sure whether they were getting Truvada or an inactive placebo. The Partners PrEP study enrolled 4,758 heterosexual couples in which one member was infected with HIV and one was not. Truvada reduced the risk of HIV infection by 75%. In the real world, however, it is not at all clear whether people who take Truvada will also take more risks, such as having sex without condoms or having multiple sex partners. Moreover, Truvada must be taken every day in order to help prevent HIV infection. People in clinical trials did this. But if that doesn't happen in the real world, people who get infected while taking too few doses likely will end up with drug-resistant HIV infection that they can then spread to others. Reaction Mixed "The FDA's move today is negligence bordering the equivalence of malpractice, which will sadly result in new infections, drug resistance, and serious side effects among many, many people," Michael Weinstein, president of the AIDS Health Foundation, says in a news release. The AHF provides AIDS health care in 26 nations. Other AIDS groups feel differently. The Black AIDS Institute supports the use of PrEP, as does Fenway Health, a provider of health services to Boston's lesbian, gay, bisexual, and transgender community. "This approach can prevent many new infections and could dramatically impact HIV transmission worldwide as part of the tools we have available to stop the epidemic," Fenway medical director Kenneth H. Mayer, MD, says in a news release. Last May, an FDA advisory panel voted in favor of approving Truvada for PrEP. The panel voted overwhelmingly to approve PrEP for men who have sex with men and for uninfected partners of HIV-infected people. But the panel approved Truvada PrEP by only a 12-8 vote for others at risk of HIV infection.

Birnkrant noted that the FDA approval comes with a risk-reduction program. Doctors prescribing Truvada PrEP must ensure that patients test negative for HIV before taking the drug. New tests are advised every three months at least. In addition, people must be monitored for signs of kidney or bone problems -- which are among the long-term side effects sometimes seen with Truvada. And the FDA says it will stay in close touch with those prescribing and taking Truvada PrEP to fine-tune the risk-reduction program. "Education is the key," Birnkrant said. "We are committed to working with our public health colleagues to learn how best to use Truvada for PrEP so we can fully achieve the public health benefit it represents." Truvada costs about $1,100 a month. It's not yet clear whether Truvada PrEP will be covered by insurance. SOURCES: News conference, FDA, July 16, 2012. News release, Fenway Health. News release, AIDS Health Foundation. FDA web site. News release, Gilead. WebMD Health News: "FDA Panel OKs Truvada as First HIV-Preventive Drug." ©2012 WebMD, LLC. All Rights Reserved.

Honey, I Am Not Pregnant, We Will Have To Keep Trying

Many couples have children as soon as they look at each other in a certain way, or so it seems. Lots of couples do have problems conceiving children. There are several possible reasons for this and several possible solutions to the problem. Gone are the days of Britain's Henry VIII who chopped off his wives' heads if they failed to produce a child within a year. Nowadays people realize that this is a difficulty that is a shared one. If specialists find that one of the partners' reproductive system is not working as it should then that person will need substantial support from their partner. Most men do not have the Henry VII approach. Most will be willing to have tests done to determine a sperm count and to check on the activity of the sperm. This is usually the first step in determining the reason for lack of conception of a child because production of the sperm sample is very simple and certainly does not require invasive surgery. Sperm counts can sometimes be increased by hormone supplements. Be aware that increasing testosterone levels will also cause increased aggressiveness in social situations. I knew a guy once in this situation and all his workmates breathed a sigh of relief when he announced his wife was pregnant. Investigating the female reproductive system is much more complicated. That's why there are gynaecologists for women and no equivalent for men. I am not going to go into the many vagaries of the menstrual cycle here. Following the advice of a gynaecologist will help many women to become pregnant.

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