HHS WEEKLY REPORT
December 15 - 21, 2003

THIS ISSUE AVAILABLE ONLINE WITH EXPANDED INFORMATION AND PHOTOS AT:
http://www.hhs.gov/news/newsletter/weekly

IN THIS ISSUE:
1) Secretary Thompson Announces Availability of Medicare-Approved Drug Discount Card by Next Spring
2) HHS to Fund Early Warning Disease Surveillance System Along the U.S.-Mexico Border
3) Combination, Order of Anti-HIV Drugs Make a Difference in First-time Recipients
4) Key Facts About the Flu
5) Secretary Thompson's Public Schedule:

Secretary Thompson Announces Availability of Medicare-Approved Drug Discount Card by Next Spring

Health and Human Services Secretary Tommy G. Thompson announced that HHS is taking steps to ensure that a Medicare prescription drug discount card will be available by next spring. The regulation included in the Medicare modernization bill signed by President Bush allows seniors to qualify for reduced-prices for their prescription drugs from 10 - 25 percent until the new Medicare benefits take effect in 2006.

"We are excited that President Bush's goal of modernizing Medicare and providing a drug benefit has finally been met," said Secretary Thompson said. "We will work vigorously to create the structure for the new drug benefit that will be available in 2006 to all beneficiaries. In the meantime, millions of older and disabled Americans will benefit from the drug discount card that will be available next spring. These Americans have been paying full price for their drugs for too long. The drug discount card will help them lower those costs until the more comprehensive Medicare drug benefit comes into effect in two years."

Medicare beneficiaries will have a choice of at least two Medicare-approved cards, but be allowed to enroll in only one drug card program at a time. The cost of enrollment can be no more than $30 annually. Beneficiaries can change cards during an open enrollment period prior to 2005 or under special circumstances. Beginning in 2006, all people with Medicare will have access to a voluntary prescription drug benefit.

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HHS to Fund Early Warning Disease Surveillance System Along the U.S.-Mexico Border

HHS Secretary Tommy G. Thompson announced $5.4 million in funds to enhance early warning capabilities for bioterrorism and infectious diseases while he was in Saltillo, Mexico for a U.S. - Mexico Border Health Commission annual meeting last week.

The cooperative program is to be implemented over a three-year period and will aim toward improving early detection, identification, and reporting of infectious diseases in relation to bioterrorism threats and infectious diseases that pose a threat to public health along the U.S. - Mexico border. "Disease and illness recognize no political boundaries and that's why it's imperative that our countries continue to work together to safeguard the health of those along both sides of the border," Secretary Thompson said. "Early warning surveillance and prompt sharing of findings is a public health and national security imperative for both our nations."

The agreement will build upon previous bi-national activities between the United States and Mexico and will be carried out through Mexico's National Council Against Addictions and the National Institute on Drug Abuse (NIDA), part of HHS' National Institutes of Health.

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Science in the News
Combination, Order of Anti-HIV Drugs Make a Difference in First-time Recipients

How anti-HIV drugs are combined and the order in which they are given are important factors to consider when designing treatment strategies for patients new to antiretroviral therapy, says a new study funded by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health. When HIV-infected individuals begin treatment with a combination of the drugs zidovudine, better known as AZT, lamivudine and efavirenz, the drugs retain their effectiveness for a longer period of time than when individuals begin treatment with one of several other three-drug regimens.

The study, which involved researchers and participants from the United States and Italy, was one of the largest and most complex of its kind to help in determining the optimal drug treatment strategy for first-time recipients of antiretroviral drugs. The findings are reported in two papers published in the Dec. 11 issue of The New England Journal of Medicine, and have been incorporated into the U.S. Department of Health and Human Services HIV/AIDS Treatment Guidelines. "These findings offer new insight into the most effective approach for treating previously untreated HIV-infected individuals," said Anthony S. Fauci, M.D., director of the NIAID. "Through well-conceived, collaborative clinical studies such as this one, researchers are learning how to use the many anti-HIV drugs now on the market to provide the maximum benefit for the longest period of time."

Highly active antiretroviral therapy (HAART) employs combinations of anti-HIV drugs to help suppress the virus in people with HIV/AIDS. The goal of HAART is to combine three or more drugs from one or more different classes of anti-HIV drugs to suppress HIV replication and prevent progression to AIDS and death. Two key classes include those that prevent the virus from copying itself, called reverse transcriptase (RT) inhibitors, and those that prevent the virus from becoming infectious, called protease inhibitors. RT inhibitors can be further broken down into nucleoside RT inhibitors, which halt HIV replication by making faulty DNA building blocks, and non-nucleoside inhibitors, which bind to the enzyme reverse transcriptase to prevent the virus from copying itself. The effectiveness of different drug combinations may diminish over time, however, and physicians often must implement new ones over the course of a person's treatment.

"Until now, it has been unclear which sequences of antiretroviral regimens provide the greatest benefit to patients previously untreated," said Gregory K. Robbins, M.D., clinical researcher at Massachusetts General Hospital and instructor in medicine at Harvard Medical School, and lead author of one of the papers. "Findings from this and similar studies can help reduce some of the guesswork involved, enabling physicians to develop the most effective treatment plan for their HIV-positive patients."

Study Description

In the first part of the study, Robbins and a team of researchers compared the effectiveness of four three-drug sequencing strategies over roughly a two-year period in 620 HIV-positive individuals who had never before received antiretroviral therapy. Two groups began treatment with didanosine (ddI) and stavudine (d4T), two nucleoside RT inhibitors, with one group also receiving efavirenz (EFV), a non-nucleoside RT inhibitor, and the other receiving nelfinavir (NFV), a protease inhibitor. Two other groups began treatment with zidovudine (ZDV) and lamivudine (3TC), two other nucleoside RT inhibitors, combined, again, with either EFV or NFV. If the initial regimens failed, patients were given all new HIV medications. For example, the patients failing ddI, d4T and EFV switched to ZDV, 3TC and NFV, while the group that began with ZDV, 3TC and EFV followed up with ddI, d4T and NFV, and so on. The primary measure of a sequence's success was the amount of time before the second regimen failed: the greater the delay, the more successful the sequence. Secondary measures included amount of time before the first regimen failed, as well as ability to suppress viral replication, development of resistance to anti-HIV drugs and drug toxicity.

In the second part of the study, Robert W. Shafer, M.D., assistant professor of medicine at Stanford University Medical Center, and colleagues sought to determine how two four-drug regimens compared in effectiveness with the three-drug sequential regimens. Three-hundred sixty HIV-positive individuals who had never before received antiretroviral treatment were given one of two four-drug treatments: ddI, d4T, EFV and NFV or ZDV, 3TC, EFV and NFV. A key question in this comparison was whether incorporating three anti-HIV drug classes instead of two increases the potency of a drug combination at the expense of increasing the risk of toxicity or drug resistance. Because participants were exposed to three drug classes in the initial regimen, there was no second regimen. Therefore, the primary measure of success was the amount of time before the initial treatment failed (compared with two failures of the sequential three-drug regimens), with secondary measures remaining the same as before.

Major Findings

All six regimens successfully controlled HIV infection. Patients who received ZDV, 3TC and EFV as the first or second regimen delayed failure of the second regimen compared to those who took other three-drug regimens, and patients who started with ZDV, 3TC and EFV delayed first regimen failure compared to the other three-drug treatments. These findings indicate that the combination of ZDV, 3TC and EFV is the best choice for initiating antiretroviral therapy among the drugs studied. In addition, researchers found that after 48 weeks on the initial regimen, approximately 10 percent of individuals taking ZDV, 3TC and EFV experienced failure, as opposed to the other three-drug regimens, in which approximately 30 to 40 percent of individuals experienced failure.

The researchers also found that in regard to the primary measure of success, the four-drug treatments were no more potent than sequential three-drug regimens. In several secondary measures however, such as time to first regimen failure and development of drug resistance, they outperformed all three-drug regimens except one - ZDV, 3TC and EFV. Finally, although the risk of drug toxicity was no different between four-drug regimens and three-drug sequential treatments, drug toxicity was found to occur more frequently in individuals who began treatment with ddI and d4T than in those who began treatment with ZDV and 3TC. Such individuals experienced more health-related problems such as peripheral neuropathy, a neurological disorder resulting from damage to the peripheral nerves, or inflammation to the pancreas, among other problems. Based in part on the results of this study, leading researchers now recommend that anti-HIV treatment should not begin with regimens that contain both ddI and d4T.

Background

The study was conducted by the Adult AIDS Clinical Trials Group (AACTG), an NIAID-sponsored program that consists of a network of more than 30 clinical research institutions in the United States, with international collaborations. AACTG conducts all phases of clinical trials designed to assess the safety and efficacy of new and improved therapies for HIV/AIDS and its associated illnesses, including those in which combination drugs from different manufacturers are evaluated. AACTG sites are funded through cooperative agreements. This study was conducted in collaboration with the Istituto Superiore di Sanitā, the Italian National Institute of Health, and enrolled both U.S. and Italian subjects. Pharmaceutical sponsors contributed medications and financial support for the study. The drugs ZDV and 3TC are manufactured by GlaxoSmithKline; ddI, d4T and EFV are manufactured by Bristol-Myers Squibb Company; and NFV is manufactured by Pfizer.

NIAID is a component of the National Institutes of Health (NIH), an agency of the Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

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Personal Health

Key Facts About the Flu

Influenza is a contagious respiratory illness caused by influenza viruses. Infection with influenza viruses can result in severe illness and life-threatening complications. An estimated 10 percent to 20 percent of U.S. residents get the flu each year. An average of 114,000 people are hospitalized for flu-related complications, and an average of 36,000 Americans die each year from complications of flu.

Flu symptoms include fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, and muscle aches. Gastro-intestinal symptoms, such as nausea, vomiting, and diarrhea, are much more common among children than adults.

Spread of Flu

Influenza viruses are spread when a person who has the flu coughs, sneezes, or speaks and spreads virus into the air, and other people inhale the virus. When these viruses enter the nose, throat, or lungs of a person, they begin to multiply, causing symptoms of the flu. The viruses can also be spread when a person touches a surface with flu viruses on it (for example, a door handle) and then touches his or her nose or mouth.

A person who is sick with the flu can spread viruses - that means they are contagious. Adults may be contagious from one day before developing symptoms to up to seven days after getting sick. Children can be contagious for longer than seven days.

Preventing Flu

Vaccination: The single best way to prevent the flu is to get vaccinated each fall. In the absence of vaccine, however, there are other ways to protect against flu.

Antiviral Medications: Three antiviral drugs (amantadine, rimantadine, and oseltamivir) are approved and commercially available for use in preventing flu. All of these medications are prescription drugs, and a doctor should be consulted before the drugs are used for preventing the flu.

Other Habits for Good Health

The following steps may help prevent the spread of respiratory illnesses like flu:

Diagnosing the Flu

Tests are available that can determine if you have the flu as long as you are tested within the first 2 or 3 days after your symptoms begin. In addition, a doctor's examination may be needed to determine whether a person has another infection that is a complication of the flu.

At Special Risk of Complications From Flu

Certain people are at increased risk for serious complications from the flu. This group includes people age 65 years and older and people of any age with chronic medical conditions. Pregnant women and children between 6 months and 23 months of age also are at increased risk from flu complications.

Complications From Flu

Some of the complications caused by flu include bacterial pneumonia, dehydration, and worsening of chronic medical conditions, such as congestive heart failure, asthma, or diabetes. Children may get sinus problems and ear infections.

Treating the Flu

Antiviral Medications: Four antiviral drugs (amantadine, rimantadine, zanamavir and oseltamivir) have been approved for treatment of the flu. All of these must be prescribed by a doctor. Antiviral treatment lasts for 5 days and must be started within the first 2 days of illness.

What to Do If You Get Sick This Flu Season

If you develop the flu, it is advisable to get plenty of rest, drink a lot of liquids, and avoid using alcohol and tobacco. Also, you can take medications to relieve the symptoms of flu (but never give aspirin to children or teenagers who have flu-like symptoms - and particularly fever - without first speaking to your doctor.)

If, however, your flu symptoms are unusually severe (for example, if you are having trouble breathing), you should consult your health-care provider right away.

If you are at special risk from complications of flu, you should consult your health-care provider when your flu symptoms begin. This includes people 65 years or older, people with chronic medical conditions, pregnant women, or children . Your doctor may choose to use certain antiviral drugs to treat the flu.

For more information, visit www.cdc.gov/flu, or call the National Immunization Hotline at (800) 232-2522 (English), (800) 232-0233 (espaņol), or (800) 243-7889 (TTY).

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Secretary Tommy G. Thompson's public schedule:

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Last updated: December 16, 2003
United States Department of Health and Human Services
Contact the HHS Newsletter Team.