National HIV Vaccine Awareness Day May 18, 2011

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Statement of Anthony S. Fauci, M.D.
Director, National Institute of Allergy and Infectious Diseases
National Institutes of Health

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Thirty years since the first report of the disease we now know as AIDS, scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, continue advancing toward our goal of a vaccine to prevent HIV infection. I am optimistic that we will succeed.

We have scientific evidence that a safe and effective HIV vaccine is possible. In 2009, a clinical trial in Thailand involving 16,000 people demonstrated for the first time that a vaccine could safely prevent HIV infection in a modest proportion of study participants. Many of the best minds in HIV vaccine science are examining blood samples and data from the Thai trial to learn how the vaccine candidate prevented HIV infections and to consider how it could be modified to be more effective.

To speed the pace at which promising HIV vaccine candidates become viable for evaluation in large clinical trials, NIAID is exploring the use of innovative or adaptive clinical trial designs that let scientists quickly modify ongoing trials in response to data acquired during the study. Such flexibility in trial design will allow the research community to maximize efficiencies in studying vaccine candidates.  

Clinical trials of HIV vaccines depend on the participation of thousands of volunteers as well as community educators, health care workers and scientists. I am extremely grateful to the many people who devote their time and energy to these essential clinical studies.

Every HIV vaccine candidate is created in the laboratory. Some NIAID-supported laboratory scientists are charting a new course by designing HIV vaccine candidates based on knowledge of the protein structure of the surface spikes that HIV uses to attach to and infect human cells. These spikes have sites that are vulnerable to powerful antibodies, which block laboratory infection of human cells by more than 90 percent of tested HIV strains from around the globe. Now the scientists are mapping a strategy to create a vaccine that can stimulate a healthy person to make such broadly neutralizing antibodies.

To guide HIV vaccine design, other NIAID-supported scientists are building on evidence that in most individuals, only a small number of HIV particles—often just one—are responsible for establishing a sexually transmitted HIV infection. These researchers are identifying the unique qualities of these infection-causing forms of the virus to help other scientists design vaccines that target the specific HIV variants that penetrate the body’s defenses. 

No matter how effective a preventive HIV vaccine is, however, we will need to evaluate and administer it in combination with other biomedical and behavioral HIV prevention tools. No single HIV prevention strategy will control and ultimately end the HIV/AIDS pandemic. That is why it is important for NIAID to continue supporting promising research on vaginal and rectal microbicides, pre-exposure prophylaxis (PrEP) and expanded HIV testing with linkage to care. That is also why public health workers will continue to advocate and implement scientifically proven HIV prevention strategies such as condom use, medically supervised adult male circumcision, harm-reduction strategies for injection drug users and the prevention of mother-to-child transmission of HIV.

On this extraordinarily challenging journey to develop a preventive HIV vaccine, taking a moment today to reflect on our progress gives us all renewed hope that our goal is achievable.

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.

NIH Study Finds Omalizumab Relieves Seasonal Asthma Attacks in Youth

 

Symptoms Reduced in Children and Young People with Moderate to Severe Disease

A drug that targets the antibody immunoglobulin E (IgE), a key player in asthma, nearly eliminated seasonal increases in asthma attacks and decreased asthma symptoms among young people living in inner city environments, a clinical trial sponsored by the National Institutes of Health has found.

The findings will appear in the March 17 issue of the New England Journal of Medicine.

This investigational use of the drug omalizumab, sold under the brand name Xolair, was conducted in eight U.S. cities by the Inner City Asthma Consortium (ICAC), a nationwide clinical trials network supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. Additional support for this research was provided by the NIH National Center for Research Resources and Novartis Pharmaceuticals Corporation.

“We know that treatment based on NIH asthma guidelines is generally effective in managing the disease, but many patients still experience asthma attacks requiring visits to emergency rooms and hospitalizations,” says NIAID Director Anthony S. Fauci, M.D. “The results of this study are extremely promising because they show that the addition of omalizumab to the NIH guidelines-based therapy for asthma offers improved asthma control and the potential to decrease the burden of this chronic disease in children and adolescents.”

In the United States, asthma affects approximately 18 million adults and 7 million children under the age of 18. Symptoms include wheezing, coughing, chest tightness and shortness of breath, any of which can be provoked by viral infections, allergens and air pollution. The number of asthma attacks rises in the spring and fall seasons when more allergens are in the air and the occurrence of respiratory viruses increases.

The study enrolled 419 children and youths, ages 6 to 20 years old, diagnosed with moderate to severe allergic asthma lasting more than one year. The children came from Boston, Chicago, Cleveland, Dallas, Denver, New York City, Tucson, Ariz. and Washington, D.C. Nearly all were minorities, including African-Americans (60 percent) and Hispanics (37 percent). 

The primary goal of the study was to determine if adding omalizumab to NIH guidelines-based asthma therapy reduced the number of days that participants experienced any asthma-related symptoms.  Another aim was to find out if the addition of omalizumab could also reduce the number of severe asthma attacks. 

In addition to standard therapy, half of the participants were assigned at random to receive omalizumab, and the other half a placebo. Drug or placebo was delivered via an injection under the skin every two to four weeks over the 60-week period of study.

As the trial proceeded, participants returned to the clinic every three months for evaluation of their symptoms. As needed, their non-trial medications were adjusted according to the NIH asthma treatment guidelines.

At the end of the study, the investigators found that, overall, children and adolescents who received omalizumab had a 25 percent reduction in days with symptoms and a 30 percent reduction in asthma attacks compared with those who received placebo. Those who received omalizumab also had a 75 percent reduction in hospitalizations. Importantly, the spring and fall increases in asthma attacks that were seen in the participants receiving placebo were almost eliminated in those participants receiving omalizumab. 
“The spike in asthma attacks in the fall, which is associated with colds and other viral airway infections, disappeared in the kids in the omalizumab group,” says William Busse, M.D., the principal investigator of ICAC and professor of medicine at the University of Wisconsin-Madison. “Because the drug specifically targets IgE, which is the antibody responsible for allergies, our observations show the possible interplay between allergies, respiratory viruses and IgE in provoking asthma attacks.”

Certain bacteria render mosquitoes resistant to deadly malaria parasite

 

Results of NIH-funded study could help prevent malaria

Scientists have identified a class of naturally occurring bacteria that can strongly inhibit malaria-causing parasites in Anopheles mosquitoes, a finding that could have implications for efforts to control malaria. The study, led by George Dimopoulos, Ph.D., of the Bloomberg School of Public Health and the Malaria Research Institute, both of Johns Hopkins University, Baltimore, appears in the May 13 edition of Science. The research was partly funded by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health.

According to the World Health Organization, an estimated 225 million malaria cases occur worldwide annually, resulting in about 781,000 deaths. Although the disease is present in 106 countries, most cases occur in sub-Saharan Africa. Insect repellent and bed nets can help prevent transmission of the malaria parasite from mosquitoes to humans, but to control malaria one step earlier, some studies are looking to eliminate infection within the mosquito itself.

Normally, when a malaria parasite infects a mosquito, it travels to the insect’s gut, where its chances for survival are slim because the mosquito’s immune system, digestive enzymes and resident bacteria create a hostile environment. In their new study, the scientists found that among the various types of bacteria in the mosquito gut, Enterobacter—a type of bacteria that occurs in some but not all mosquitoes—effectively blocked infection with the malaria-causing parasite Plasmodium falciparum.

"This discovery may explain why some mosquitoes are better than others at transmitting malaria to humans, even when they are of the same species," explained NIAID Director Anthony S. Fauci, M.D.

The Hopkins researchers found that in the presence of Enterobacter, various developmental stages of the P. falciparum parasite—including the stage that is transmitted to humans through a mosquito bite—were reduced by 98 to 99 percent.

"Our study used a laboratory method of P. falciparum infection, which causes stronger infections than those that take place in a natural environment," explained Dr. Dimopoulos. "We believe that in a natural situation, where infection levels are much lower, this bacterium would eliminate the parasite. Further, there is no evidence that Enterobacter is toxic to either mosquitoes or humans."

By observing the interaction between the bacteria and the parasite, the scientists determined that Enterobacter inhibits parasite growth by producing short-lived molecules known as reactive oxygen species (ROS). Although ROS travel through body fluids in the mosquito, they do not need to be in a mosquito to inhibit parasites.

Future research plans include sequencing the Enterobacter genome to better understand how it produces malaria-inhibiting ROS and studying other bacteria that reside in the mosquito gut to learn whether they have similar effects.

"If we can find a correlation between mosquitoes’ malaria infection status and the presence or absence of a particular bacterium, it may suggest that the bacterium inhibits malaria parasites," said Dr. Dimopoulos. Identifying a variety of malaria-inhibiting bacteria would be especially useful since not all mosquitoes have Enterobacter in their guts.

The researchers hope to apply their findings to the field, where they would first modify Enterobacter for use in mosquitoes. The next step would be to strategically place the bacteria in the mosquitoes’ natural environment, such as in their sugar food sources or breeding sites. Although these strategies have not yet been tested in malaria prevention, sugar baits have been used successfully to expose mosquitoes to toxins.

"This is a novel way of looking at how the mosquito and malaria parasite interact," said Adriana Costero-Saint Denis, Ph.D., program officer in NIAID’s Vector Biology Program. "It adds another layer to the study of malaria."

For more information about NIAID’s malaria research, see the NIAID malaria Web portal.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site athttp://www.niaid.nih.gov.

FDA 101: Smoking Cessation Products

 

If you want to quit smoking, you'll need willpower—and perhaps the aid of a product that's intended to help you beat the addiction.

The Food and Drug Administration (FDA) has approved a variety of smoking cessation products. These include prescription medicines as well as over-the-counter (OTC) products such as skin patches, lozenges, and gum.

Smoking cessation products are regulated through FDA’s Center for Drug Evaluation and Research, which ensures that the products are effective and that their benefits outweigh any known associated risks

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First, Learn About the Products

While these products are intended to help you quit smoking and improve your health, it’s important to know how they work and what side effects they may cause.

For example, many approved smoking cessation products help users wean themselves from smoking by using specific amounts of nicotine, the drug present in the tobacco plant which is primarily responsible for people's addiction to tobacco products.

And, as is the case with other medications, there are risks and other considerations associated with the various products that consumers must weigh against the benefits.

Reading labels and talking to your pharmacist and other health care professionals are good initial steps to take when considering the use of smoking cessation products. You can also check FDA's Web site for more information on each product at Drugs@FDA.

 

The Benefits of Stopping

Beating the addiction to smoking will bring you a multitude of benefits. Not only will you lower your risk of getting various cancers, including lung cancer, you'll also reduce your chances of suffering from heart disease, stroke, emphysema, and other serious diseases. Also, stopping will help prevent heart disease and lung cancer in people who are subjected to your second-hand smoke.

Although there are benefits to quitting at any age, it is important to quit as early in life as possible to avoid getting one of these serious illnesses caused by smoking.

Keep in mind that

• smoking kills 1,200 people every day in the United States
• if you do not quit smoking, you have a one out of two chance of dying of a smoking-related disease

 

Nicotine Replacement Products

Nicotine replacement products are one type of smoking cessation product. Designed to wean your body off cigarettes, they supply you with nicotine in controlled amounts while sparing you from other chemicals found in tobacco products.

As you go about quitting smoking, you may experience symptoms of nicotine craving and withdrawal. These symptoms—which include an urge to smoke, depression, trouble sleeping, irritability, anxiety, and increased appetite—may occur no matter which method of stopping you choose.

Available over the counter and by prescription, nicotine replacement products should be used for a short time to help you deal with nicotine craving and withdrawal.

If you are under 18 years of age and want to quit smoking, you should talk to a health care professional about the potential for using nicotine replacement therapies.

OTC nicotine replacement products are sold under brand names and private labels, and as generic products. They are approved for sale to persons 18 years of age and older.

OTC nicotine replacement products include

• skin patches available as generics known as transdermal nicotine patches, as private-label products, and under the brand names Habitrol and Nicoderm. These patches are affixed to the skin, similar to how you would apply an adhesive bandage
• chewing gum available as a generic product known as nicotine gum, as private-label products, and under the brand name Nicorette
• lozenges available as generics known as nicotine lozenges, as private-label products, and under the brand name Commit

Prescription-only nicotine replacement products are available only under the brand name Nicotrol and are available both as a nasal spray and an oral inhaler.

There is important advice to consider before beginning a nicotine replacement therapy.

• You should stop using a nicotine replacement product and call your health care professional if you experience nausea, dizziness, weakness, vomiting, fast or irregular heartbeat, mouth problems with the lozenge or gum, or redness or swelling of the skin around the patch that does not go away.
• Don’t use any other product containing nicotine while using a nicotine replacement product.
• Women who are pregnant or breast-feeding should use these products only with approval from their health care professional.
• Talk to your health care professional before using these products if you have
  • diabetes, heart disease, asthma, or stomach ulcers
  • had a recent heart attack
  • high blood pressure that is not controlled with medicine
  • a history of irregular heartbeat
  • been prescribed medication to help you quit smoking
• If you take prescription medication for depression or asthma, let your health care professional know if you are quitting smoking; your prescription dose may need to be adjusted.

 

Products Not Containing Nicotine

Two medicines that do not contain nicotine have FDA's approval as smoking cessation products. They are Chantix (varenicline tartrate) and Zyban (buproprion). Both are available in tablet form on a prescription-only basis.

In July 2009, FDA required both products to carry new safety information in a boxed warning on their labeling for health care professionals citing serious risks for users taking these drugs. These risks include changes in behavior, depressed mood, hostility, and suicidal thoughts or actions.

Read the product's patient medication guide in its entirety if you use or plan to use either Chantix or Zyban. These guides offer important information on adverse affects, risks, warnings, product ingredients, and what you should talk about with your health care professional before taking the products.

Chantix acts at sites in the brain affected by nicotine. It provides some nicotine effects to ease withdrawal symptoms and blocks the effects of nicotine from cigarettes if users resume smoking.

The medication guide for Chantix states that the product is not recommended for people under 18 years of age.

The most common side effects of Chantix include nausea; constipation; gas; vomiting; and trouble sleeping or vivid, unusual, or strange dreams.

In addition to the warnings about changes in behavior, depressed mood, hostility, and suicidal thoughts or actions when taking this drug, the patient medication guide for Chantix cites other adverse affects and risks—including allergic reactions, serious skin reactions, and trouble driving or operating heavy machinery.

Stop taking Chantix and call your health care professional right away if you notice any of these symptoms, or develop other symptoms included in the medication guide for patients.

Zyban helps patients to abstain from smoking; however, the precise means by which it accomplishes this is unknown.

The medication guide for Zyban states that the product has not been studied in children under the age of 18 and is not approved for use in children and teenagers.

The most commonly observed adverse events consistently associated with the use of Zyban are dry mouth and insomnia.

In addition to warnings about the risks of serious psychiatric problems, the medication guide for Zyban cites other adverse events and risks related to this product, including seizures, high blood pressure, and allergic reactions.

Since Zyban contains the same active ingredient as the antidepressant Wellbutrin, users and potential users are urged to talk to their health care professional about risks and benefits of treatment with antidepressant medicines.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Dry Mouth? Don’t Delay Treatment

                                                                                                                                            Almost everyone’s mouth is dry sometimes. But if you feel like you have cotton in your mouth constantly, it may be time for treatment.

Dry mouth, known medically as xerostomia, occurs when you don’t have enough saliva, or spit, in your mouth.

Feeling stressed can trigger dry mouth temporarily. But a persistently dry mouth may signal an underlying disease or condition, so it’s important to see your doctor, says the Food and Drug Administration (FDA), which regulates products that relieve dry mouth.

And because dry mouth can lead to tooth decay, you should see your dentist, too, says John V. Kelsey, D.D.S., of FDA’s Division of Dermatology and Dental Products.

Dry mouth may make it difficult to speak, chew, and swallow, and may alter the taste of your food. It can also cause a sore throat, hoarseness, and bad breath.

Dry mouth can affect people of any age, but older people are especially vulnerable. “It’s not a normal consequence of aging,” says Kelsey. “Older people may take multiple medications that can cause dry mouth.”

According to the Surgeon General's Report on Oral Health in America, dry mouth is a side effect of more than 400 prescription and over-the-counter drugs, such as antidepressants, antihistamines, muscle relaxants, and high blood pressure medicines. 

Other causes of dry mouth include:

• cancer treatments, such as chemotherapy and radiation of the head or neck
• hormone changes, such as those that occur during pregnancy or menopause
• health problems, such as HIV/AIDS, diabetes, and Sjögren’s syndrome, a disease in which a person’s immune system attacks the body’s tissues, including moisture-producing glands
• snoring or breathing open-mouthed

The Role of Saliva

Saliva is produced by three major glands in the mouth (salivary glands) and plays a key role in

• chewing, swallowing, and digesting food
• preventing infection in the mouth by controlling bacteria
• preventing tooth decay

“Saliva is mostly water, but it also contains enzymes and lubricants,” says Kelsey. “The enzymes help digest food and the lubricants make speaking, chewing, and swallowing more comfortable.”

Saliva helps control bacteria, which cling to the surface of teeth. They feed on sugar in the food we eat and break down and use (metabolize) the sugar to grow.

“A by-product of the metabolized sugar is acid, which starts to eat away at a tooth’s surface,” says Kelsey. Saliva neutralizes the acid and helps wash away food particles. If there is not enough saliva, cavities may occur.  

Dry Mouth Treatments

Your doctor or dentist may recommend oral rinses and moisturizers, or prescribe an artificial saliva.

Also called saliva substitutes, artificial salivas are regulated by FDA as medical devices. “Unlike drugs, artificial salivas have no chemical action,” says Susan Runner, D.D.S., chief of FDA’s dental devices branch. “Their action is mechanical. They moisten and lubricate the mouth but do not stimulate the salivary glands to make saliva.”

While not a cure, artificial salivas can provide short-term relief of the symptoms of dry mouth. “They can also help minimize discomfort after an oral procedure,” says Runner.

Artificial salivas come in a variety of forms, including rinses, sprays, swabs, gels, and tablets that dissolve in the mouth. Some are available by prescription only; others can be bought over-the-counter.

FDA has also approved several prescription drugs to relieve dry mouth caused by certain medical treatments or conditions, such as Sjögren's syndrome and radiation for head or neck cancer.

Advice for Consumers

If you have persistent dry mouth:

• Talk to your doctor, who may change your medications or adjust the doses.
• Talk to your dentist and provide a list of the medicines you take as well as any medical conditions or treatments you’ve had. The American Dental Association recommends seeing your dentist at least twice a year.

Tips for Relieving Dry Mouth

• Sip water or sugarless drinks, or suck on ice chips.
• Avoid irritants, such as alcohol, tobacco, and caffeine. Remember that caffeine is found in many sodas as well as in coffee and tea.
• Chew sugar-free gum or suck on sugar-free candy.
• Avoid salty or spicy foods, which may irritate the mouth.
• Use a humidifier in your bedroom at night.
• Consider using saliva substitutes.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

May 9, 2011

 

For More Information

• NIH: Dry Mouth
• American Dental Association: Dry Mouth

FDA clears first test to quickly diagnose and distinguish MRSA and MSSA

 

The U.S. Food and Drug Administration today cleared the first test for Staphylococcus aureus (S.aureus)  infections that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA).

There are many different types of Staphylococci bacteria, which cause skin infections, pneumonia, food and blood infections (blood poisoning). While some S.aureus infections are treated easily with antibiotics, others are resistant (MRSA) to commonly prescribed antibiotics such as penicillin and amoxicillin.

The KeyPath MRSA/MSSA Blood Culture Test determines whether bacteria growing in a patient’s positive blood culture sample are MRSA or MSSA within about five hours after any bacterial growth is first detected in the sample. Aside from blood culture equipment, the test does not require any specific instruments to get results, which makes it useful in any laboratory.

“Clearing this test gives health care professionals a test that can confirm S.aureus and then identify whether the bacteria is MRSA or MSSA,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health. “This not only saves time in diagnosing potentially life-threatening infections but also allows health care professionals to optimize treatment and start appropriate contact precautions to prevent the spread of the organism.”

MRSA infections can occur anywhere; however, infections appearing in health care settings are usually more severe and potentially life-threatening given patients being treated in those facilities may have weakened immune systems and frequently undergo procedures such as surgery, which allows an easier spread of bacteria directly into the body.

The FDA based its clearance on a clinical study of 1,116 blood samples evaluated at four major U.S. hospital centers. Within the organisms determined to be S.aureus, the MRSA determination was 98.9% accurate (178/180) and the MSSA determination was 99.4% accurate (153/154).

The KeyPath MRSA/MSSA Blood Culture Test is manufactured by MicroPhage Inc. of Longmont, Colo.

For more information:

FDA: Medical Devices

FDA: Device Approvals and Clearances

CDC: MRSA Infections

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Ten Tips to Prevent an Accidental Overdose

For a medicine to work for you—and not against you—you’ve got to take the right dose.

Many over-the-counter liquid medicines—such as pain relievers, cold medicine, cough syrups, and digestion aids—come with spoons, cups, oral droppers, or syringes designed to help consumers measure the proper dose. These “dosage delivery devices” usually have measurement markings on them—such as teaspoons (tsp), tablespoons (tbsp), or milliliters (mL).

But the markings aren’t always clear or consistent with the directions on the medicine’s package. The Food and Drug Administration (FDA) has received numerous reports of accidental overdoses—especially in young children—that were attributed, in part, to the use of dosage delivery devices that were unclear or incompatible with the medicine’s labeled directions for use.

On May 4, 2011, FDA issued a guidance to firms that manufacture, market, or distribute over-the-counter liquid medicines. The guidance calls for them to provide dosage delivery devices with markings that are easy to use and understand.

Parents and caregivers can do their part, too, to avoid giving too much or too little of an over-the-counter medicine. Here are 10 tips:

1. Always follow the directions on the Drug Facts label of your medicine. Read the label every time before you give the medicine.
2. Know the "active ingredient" in the medicine. This is what makes the medicine work and it is always listed at the top of the Drug Facts label. Many medicines used to treat different symptoms have the same active ingredient. So if you're treating a cold and a headache with two different medicines but both have the same active ingredient, you could be giving two times the normal dose. If you're confused, check with a doctor, nurse, or pharmacist.
3. Give the right medicine, in the right amount. Medicines with the same brand name can be sold in different strengths, such as infant, children, and adult formulas. The dose and directions also vary for children of different ages or weights. Always use the right strength and follow the directions exactly. Never use more medicine than directed unless your doctor tells you to do so.
4. Talk to your doctor, pharmacist, or nurse to find out what mixes well and what doesn't. Medicines, vitamins, supplements, foods, and beverages aren’t always compatible.
5. Use the dosage delivery device that comes with the medicine, such as a dropper or a dosing cup. A different device, or a kitchen spoon, could hold the wrong amount of medicine. And never drink liquid medicine from the bottle.
6. Know the difference between a tablespoon (tbsp) and a teaspoon (tsp). A tablespoon holds three times as much medicine as a teaspoon. On measuring tools, a teaspoon (tsp) is equal to "5 mL."
7. Know your child's weight. Dosage amounts for some medicines are based on weight. Never guess how much to give your child or try to figure it out from the adult dose instructions. If a dose is not listed for your child's weight, call your health care professional.
8. Prevent a poison emergency by always using a child-resistant cap. Relock the cap after each use. Be especially careful with any medicines that contain iron; they are the leading cause of poisoning deaths in young children.
9. Store all medicines in a safe place. Some are tasty, colorful, and many can be chewed. Kids may think they’re candy. Store all medicines and vitamins out of your child's (and your pet's) sight and reach. If your child takes too much, call the Poison Center Hotline at 800-222-1222 (open 24 hours a day, 7 days a week) or call 9-1-1.
10. Check the medicine three times before using. For any medicine, it is always good practice to first, check the outside packaging for such things as cuts, slices, or tears. Second, once you’re at home, check the label on the inside package to be sure you have the right medicine and that the lid and seal are not broken. Third, check the color, shape, size, and smell. If you notice anything unusual, talk to a pharmacist or other health care professional before using.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

May 4, 2011

Treating HIV-infected people with antiretrovirals significantly reduces transmission to partners

 

Findings result from NIH-funded international study

Men and women infected with HIV reduced the risk of transmitting the virus to their sexual partners by taking oral antiretroviral medicines when their immune systems were relatively healthy, according to findings from a large-scale clinical study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The clinical trial, known as HPTN 052, was slated to end in 2015 but the findings are being released early as the result of a scheduled interim review of the study data by an independent data and safety monitoring board (DSMB). The DSMB concluded that it was clear that use of antiretrovirals by HIV-infected individuals with relatively healthier immune systems substantially reduced transmission to their partners. The results are the first from a major randomized clinical trial to indicate that treating an HIV-infected individual can reduce the risk of sexual transmission of HIV to an uninfected partner.

“Previous data about the potential value of antiretrovirals in making HIV-infected individuals less infectious to their sexual partners came largely from observational and epidemiological studies,” said NIAID Director Anthony S. Fauci, M.D. “This new finding convincingly demonstrates that treating the infected individual—and doing so sooner rather than later—can have a major impact on reducing HIV transmission.”

Led by study chair Myron Cohen, M.D., director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill, HPTN 052 began in April 2005 and enrolled 1,763 couples, all at least 18 years of age. The vast majority of the couples (97 percent) were heterosexual, which precludes any definitive conclusions about effectiveness in men who have sex with men. The study was conducted at 13 sites in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe. The U.S. site collected only limited data because of difficulties enrolling participants into the study. However, data from one serodiscordant couple at the site was included in the DSMB’s analysis. At the time of enrollment, the HIV-infected partners (890 men, 873 women) had CD4+ T-cell levels—a key measure of immune system health—between 350 and 550 cells per cubic millimeter (mm³) within 60 days of entering the study. The HIV-uninfected partners had tested negative for the virus within 14 days of entering the study.

The investigators randomly assigned the couples to either one of two study groups. In the first group, the HIV-infected partner immediately began taking a combination of three antiretroviral drugs. In the second group (the deferred group), the HIV-infected partners began antiretroviral therapy when their CD4 counts fell below 250 cells/mm³ or an AIDS-related event, such as Pneumocystis pneumonia, occurred. Throughout the study, both groups received HIV-related care that included counseling on safe sex practices, free condoms, treatment for sexually transmitted infections, regular HIV testing, and frequent evaluation and treatment for any complications related to HIV infection. Each group received the same amount of care and counseling.

In its review, the DSMB found a total of 39 cases of HIV infection among the previously uninfected partners. Of those, 28 were linked through genetic analysis to the HIV-infected partner as the source of infection. Seven infections were not linked to the HIV-infected partner, and four infections are still undergoing analysis. Of the 28 linked infections, 27 infections occurred among the 877 couples in which the HIV-infected partner did not begin antiretroviral therapy immediately. Only one case of HIV infection occurred among those couples where the HIV-infected partner began immediate antiretroviral therapy. This finding was statistically significant and means that earlier initiation of antiretrovirals led to a 96 percent reduction in HIV transmission to the HIV-uninfected partner. The infections were confirmed by genetic analysis of viruses from both partners.

Additionally, 17 cases of extrapulmonary tuberculosis occurred in the HIV-infected partners in the deferred treatment arm compared with three cases in the immediate treatment arm, a statistically significant difference. There were also 23 deaths during the study. Ten occurred in the immediate treatment group and 13 in the deferred treatment group, a difference that did not reach statistical significance.

The study was designed to evaluate whether antiretroviral use by the HIV-infected individual reduced HIV transmission to the uninfected partner and potentially benefited the HIV-infected individual as well. Additionally, the study was designed to evaluate the optimal time for a person infected with HIV to initiate antiretrovirals in order to reduce HIV-related sickness and death. Based on their analysis, the DSMB recommended that the deferred study arm be discontinued and that the study participants be informed of the trial’s outcome.

"We want to thank the study participants for making such an important contribution in the fight against HIV/AIDS. We think that these results will be important to help improve both HIV treatment and prevention," said Dr. Cohen.

Study participants are being informed of the results. Individuals who became HIV-infected during the course of the study were referred to local services for appropriate medical care and treatment. HIV-infected participants in the deferred treatment group will be offered antiretroviral therapy. The study investigators will continue following the study participants for at least one year.

The study was conducted by the HIV Prevention Trials Network, which is largely funded by NIAID with additional funding from the National Institute on Drug Abuse and the National Institute of Mental Health, both part of the NIH. Additional support was provided by the NIAID-funded AIDS Clinical Trials Group. The antiretroviral drugs used in the study were made available by Abbott Laboratories, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/Viiv Healthcare and Merck & Co., Inc.

The 11 HIV drugs that were used in various combinations included the following:

• atazanavir (300 mg once daily)
• didanosine (400 mg once daily)
• efavirenz (600 mg once daily)
• emtricitabine/tenofovir disoproxil fumarate (200 mg emtricitabine/300 mg tenofovir disoproxil fumarate once daily)
• lamivudine (300 mg once daily)
• lopinavir/ritonavir 800/200 mg once daily (QD) or lopinavir/ritonavir 400/100 mg twice daily (BID)
• nevirapine (200 mg taken once daily for 14 days followed by 200 mg taken twice daily)
• ritonavir (100 mg once daily, used only to boost atazanavir)
• stavudine (weight-dependent dosage)
• tenofovir disoproxil fumarate (300 mg once daily)
• zidovudine/lamivudine (150 mg lamivudine/300 mg zidovudine taken orally twice daily)

In an ongoing international clinical study called Strategic Timing of Antiretroviral Therapy, NIAID is examining the optimal time for asymptomatic HIV-infected individuals to begin antiretrovirals.

For additional information about the HPTN 052 study, see the Questions and Answers. Visit the NIAID HIV/AIDS Web portal for more information about NIAID’s HIV/AIDS research.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website at www.niaid.nih.gov.

FDA approves new treatment for rare type of pancreatic cancer

 

On Thursday, the U.S. Food and Drug Administration approved Afinitor (everolimus) to treat patients with progressive neuroendocrine tumors located in the pancreas (PNET) that cannot be removed by surgery or that have spread to other parts of the body (metastatic). 

Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are fewer than 1,000 new cases in the United States each year.

“Patients with this cancer have few effective treatment options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”

The safety and effectiveness of Afinitor was established a clinical trial in 410 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease. Patients in the study were selected to receive Afinitor or placebo (sugar pill). The trial was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).

In patients treated with Afinitor, the median length of time they lived without the cancer spreading or worsening was 11 months compared with 4.6 months in patients who received placebo. Patients who received placebo were able to receive Afinitor if their disease worsened. 

In patients treated with Afinitor for neuroendocrine pancreatic tumors, the most commonly reported side effects included inflammation of the mouth (stomatitis), rash, diarrhea, fatigue, swelling (edema), stomach (abdominal) pain, nausea, fever, and headache.

Afinitor is also approved to treat patients with kidney cancer (advanced renal cell carcinoma) after they fail treatment with Sutent (sunitinib) or Nexavar (sorafenib); and  patients with subependymal giant cell astrocytoma (a type of brain cancer) associated with tuberous sclerosis (a disease that causes tumors in various parts of the body), who cannot be treated by surgery.  

Afinitor has another trade name, Zortress, and is approved to treat certain adult patients to prevent organ rejection after a kidney transplant. Zortress has a different safety profile in these patients. 

Afinitor is marketed by East Hanover, N.J.-based Novartis.

For more information:

FDA: Office of Oncology Drug Products

FDA: Approved Drugs: Questions and Answers

NCI: Pancreatic Cancer

National HIV Vaccine Awareness Day May 18, 2011

 

Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health

Thirty years since the first report of the disease we now know as AIDS, scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, continue advancing toward our goal of a vaccine to prevent HIV infection. I am optimistic that we will succeed.

We have scientific evidence that a safe and effective HIV vaccine is possible. In 2009, a clinical trial in Thailand involving 16,000 people demonstrated for the first time that a vaccine could safely prevent HIV infection in a modest proportion of study participants. Many of the best minds in HIV vaccine science are examining blood samples and data from the Thai trial to learn how the vaccine candidate prevented HIV infections and to consider how it could be modified to be more effective.

To speed the pace at which promising HIV vaccine candidates become viable for evaluation in large clinical trials, NIAID is exploring the use of innovative or adaptive clinical trial designs that let scientists quickly modify ongoing trials in response to data acquired during the study. Such flexibility in trial design will allow the research community to maximize efficiencies in studying vaccine candidates.

Clinical trials of HIV vaccines depend on the participation of thousands of volunteers as well as community educators, health care workers and scientists. I am extremely grateful to the many people who devote their time and energy to these essential clinical studies.

Every HIV vaccine candidate is created in the laboratory. Some NIAID-supported laboratory scientists are charting a new course by designing HIV vaccine candidates based on knowledge of the protein structure of the surface spikes that HIV uses to attach to and infect human cells. These spikes have sites that are vulnerable to powerful antibodies, which block laboratory infection of human cells by more than 90 percent of tested HIV strains from around the globe. Now the scientists are mapping a strategy to create a vaccine that can stimulate a healthy person to make such broadly neutralizing antibodies.

To guide HIV vaccine design, other NIAID-supported scientists are building on evidence that in most individuals, only a small number of HIV particles — often just one — are responsible for establishing a sexually transmitted HIV infection. These researchers are identifying the unique qualities of these infection-causing forms of the virus to help other scientists design vaccines that target the specific HIV variants that penetrate the body’s defenses.

No matter how effective a preventive HIV vaccine is, however, we will need to evaluate and administer it in combination with other biomedical and behavioral HIV prevention tools. No single HIV prevention strategy will control and ultimately end the HIV/AIDS pandemic. That is why it is important for NIAID to continue supporting promising research on vaginal and rectal microbicides, pre-exposure prophylaxis (PrEP) and expanded HIV testing with linkage to care. That is also why public health workers will continue to advocate and implement scientifically proven HIV prevention strategies such as condom use, medically supervised adult male circumcision, harm-reduction strategies for injection drug users and the prevention of mother-to-child transmission of HIV.

On this extraordinarily challenging journey to develop a preventive HIV vaccine, taking a moment today to reflect on our progress gives us all renewed hope that our goal is achievable.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website at www.niaid.nih.gov.

Moderate levels of secondhand smoke deliver nicotine to the brain

 

NIH-funded study shows how secondhand smoke may increase vulnerability to nicotine addiction

Exposure to secondhand smoke, such as a person can get by riding in an enclosed car while someone else smokes, has a direct, measurable impact on the brain — and the effect is similar to what happens in the brain of the person doing the smoking. In fact, exposure to this secondhand smoke evokes cravings among smokers, according to a study funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

The study, published today in Archives of General Psychiatry, used positron emission tomography (PET) to demonstrate that one hour of secondhand smoke in an enclosed space results in enough nicotine reaching the brain to bind receptors that are normally targeted by direct exposure to tobacco smoke. This happens in the brain of both smokers and non-smokers.

Previous research has shown that exposure to secondhand smoke increases the likelihood that children will become teenage smokers and makes it more difficult for adult smokers to quit. Such associations suggest that secondhand smoke acts on the brain to promote smoking behavior.

“These results show that even limited secondhand smoke exposure delivers enough nicotine to the brain to alter its function,” said NIDA Director Nora D. Volkow, M.D. “Chronic or severe exposure could result in even higher brain nicotine levels, which may explain why secondhand smoke exposure increases vulnerability to nicotine addiction.”

“This study gives concrete evidence to support policies that ban smoking in public places, particularly enclosed spaces and around children,” said Arthur Brody, M.D., of the UCLA Department of Psychiatry & Biobehavioral Sciences and corresponding author for the article.

The Surgeon General's Report concluded in 2006 that secondhand smoke causes heart disease and lung cancer in nonsmoking adults and many serious health conditions in children, including sudden infant death syndrome, respiratory infections, and more severe asthma. According to the CDC, almost 50,000 deaths per year can be attributed to secondhand smoke. For more information or for resources to help quit smoking, go tohttp://www.nida.nih.gov/DrugPages/Nicotine.html.

The study can be found online at: http://archpsyc.ama-assn.org/.

The National Institute on Drug Abuse is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world's research on the health aspects of drug abuse and addiction. The Institute carries out a large variety of programs to inform policy and improve practice. Fact sheets on the health effects of drugs of abuse and information on NIDA research and other activities can be found on the NIDA home page atwww.drugabuse.gov. To order publications in English or Spanish, call NIDA's new DrugPubs research dissemination center at 1-877-NIDA-NIH or 240-645-0228 (TDD) or fax or email requests to 240-645-0227 ordrugpubs@nida.nih.gov. Online ordering is available at http://drugpubs.drugabuse.gov. NIDA's new media guide can be found at http://drugabuse.gov/mediaguide/.

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About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visitwww.nih.gov.