Drug label changes, inclusing pediatric doses
New Ziagen drug label
Isentress continues to glow
New OI guidelines
Black people, genetics, and HIV
Roche suspends HIV drug development
Drug label changes, including pediatric doses
Three HIV drugs—Aptivus, Kaletra, and Viramune—updated their drug label and included changes in pediatric doses. The U.S. Food and Drug Administration (FDA) approved an oral solution of Aptivus in June, and the drug’s label was updated to include dosing recommendations for children ages 2 to 18 years old. Among other changes, Kaletra should not be given only once-a-day in children under 18 years of age. Also, the oral version of the anti-anxiety medication midazolam (brand name Versed and others) should not be used by people taking Aptivus or Kaletra, and the intravenous version should be monitored closely if used, with dose adjustment if needed. Viramune also expanded the category of people with liver damage who should not take the drug. In addition, the revised label states that lead-in dosing should not exceed 28 days. See the package insert or consult your pharmacist or doctor for more information.
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New Ziagen drug label
The Ziagen (generic name abacavir) drug label has also been updated, to include information on genetic testing and heart disease risk factors. Ziagen/abacavir is also found in Epzicom and Trizivir.
An inexpensive (approximately $125) genetic test should be taken before going on Ziagen. The test only looks for a very specific genetic marker which indicates the person could have an allergic-like reaction to Ziagen. This hypersensitivity reaction (HSR) is potentially dangerous. The new label states that people who previously had a suspected HSR but who had not taken the HLA-B*5701 test can try to take Ziagen again, but only if they take the test and it comes back negative. Going back on abacavir could be fatal if someone truly has HSR! HSR, however, can be difficult to diagnose, and hence the helpfulness of the update. HSR can be confused with the flu or with a reaction to other HIV medications, such as a rash with Sustiva or Viramune. The two most common symptoms of an abacavir HSR, however, are not rash, but fever and constitutional illness (muscle ache, fatigue, etc.). Other potential symptoms include gastrointestinal problems (nausea, vomiting, diarrhea, or stomach pain) and respiratory illness (difficulty breathing, cough, or pharyngitis). Abacavir HSR also gets worse with each single dose, and usually occurs early, within six weeks of going on the medication.
The other update to the drug label of the various medications that include abacavir is a statement to health care providers that they should consider underlying risk factors for coronary heart disease in patients going on abacavir, and treat those risk factors, such as high blood pressure, diabetes, and smoking. Recent news raised questions about abacavir’s role in cardiac problems (see “The Price of Surviving HIV” in the May/June 2008 issue, a round-up of therapy news.)
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Isentress continues to glow
The first in its drug class HIV drug Isentress (raltegravir) continued to show good results at 48 weeks, as it did in 24-week data which helped lead to its approval by the U.S. Food and Drug Administration (FDA) late last year. (See also The Buzz, page 49.) Isentress, an integrase inhibitor, has to date a sterling reputation with HIV treatment advocates, who credit the drug with saving the lives of many people with advanced disease and treatment experience. The findings, published in the New England Journal of Medicine, reported that in these advanced patients (the only ones allowed in studies with Isentress), 62% had undetectable viral load compared to 33% of the comparison group participants, who were taking other potent HIV drug combinations. People taking an Isentress drug combination also had a T-cell increase of 109 compared to 45 for the other group.
A subgroup analysis looked at the number of active drugs in study participants’ regimens. People with a low phenotypic or genotypic sensitivity score (PSS or GSS) have a less effective regimen, due to the development of drug resistance in their virus. In this report, of the people with a GSS score of zero, 45% of those taking Isentress had undetectable viral load, compared to 3% of those who were not taking Isentress. They had a T-cell increase of 81 compared to 11. For people with a GSS of 2, 77% of those taking Isentress were undetectable compared to 62% taking placebo (fake pill) with an optimized background therapy (OBT). Their average T-cell increases were 145 for the Isentress group and 87 for the placebo group.
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New OI guidelines
The U.S. Department of Health and Human Services (DHHS) in July published updated guidelines for the prevention and treatment of opportunistic infections (OIs) in people with HIV. Infections are considered opportunistic when they cause illness in someone with a weakened immune system. In writing for aidsmeds.com (now a part of POZ magazine), advocate David Evans reported that, “According to Dr. [Henry] Masur, a lead author of the guidelines, about one-third of people who test positive for HIV in many U.S. cities do so only after they already have AIDS and require treatment for a life-threatening [OI]—or are in immediate danger of experiencing one. So it can be misleading to consider HIV and its related illnesses a thing of the past.” This is the first major update of the guidelines in years, and a report on the changes will be published in the Morbidity and Mortality Weekly Report of the U.S. Centers for Disease Control and Prevention (CDC).
According to the introduction to the guidelines, “Major changes include: (1) more emphasis on the importance of ART for prevention and treatment of OIs, especially those for which specific chemoprophylaxis [prevention] and treatment do not exist; (2) information on diagnosis and management of immune reconstitution inflammatory syndromes (IRIS); (3) information on interferon-gamma release assays (IGRAs) for the detection of latent Mycobacterium tuberculosis infections; (4) updated information on drug interactions affecting use of rifamycin drugs for prevention and treatment of tuberculosis (TB); (5) the addition of a section on hepatitis B virus (HBV) infection; and (6) the addition of a section on malaria to the OIs of geographic interest.”
IRIS refers to the flare-up of various illnesses when a person’s immune system improves, after they go on HIV therapy. See Evan’s interview with Dr. Masur. Find the guidelines at www.aidsinfo.org or request a copy at 1-800-HIV-0440 (448-0440). Note: the guidelines are more than 200 pages long.
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Black people, genetics, and HIV
A study published in the journal Cell Host & Microbe reported that black people may be at greater risk of becoming infected with HIV because of a gene mutation. The researchers believe the mutation probably protected people in sub-Saharan Africa from a type of malaria. The study results need confirmation, but tantalized advocates of people with HIV. Previous reports from other researchers have found that African Americans have a higher rate of infection without a higher rate of risky behavior. Although several socioeconomic risk factors, such as lack of access to health care, have been cited in the higher infection rate, advocates have raised questions about possible biological mechanisms for the discrepancy. See the July 17 report of the Kaiser Daily HIV/AIDS Report at www.kaisernetwork.org. It includes a round-up of newspaper reports on the findings.
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Roche suspends HIV drug development
Roche Pharmaceuticals, the manufacturer of the HIV drugs Invirase and Fuzeon, announced that it will stop development work on new drugs against the virus. The company reported that its drugs in development do not have the promise of significant improvement over current medications on the market. Roche has spent years working on a CCR5 antagonist and a reverse transcriptase inhibitor. Officials at Roche stated that they remain committed to external HIV drug development, as well as internal and external HCV (hepatitis C virus) drug development and reseach, and have a promising pipeline of HCV drugs.
Roche statement to the HIV community:
As you know, Roche has a long-standing heritage of innovation in HIV since we initiated our protease inhibitor discovery project more than twenty years ago. Our work has resulted in major contributions in this field, among them the development of PCR diagnostic and viral load technology, the introduction of the first protease inhibitor, and the introduction of the first fusion inhibitor to patients in 2003 - despite the considerable technical challenges we faced in producing this very complex molecule on a large scale.
For several years, we have been investigating compounds targeting the CCR5 entry pathway and the reverse transcriptase enzyme. All these compounds were in pre-clinical studies, and therefore at least six years away from availability to patients. While we had initially been hopeful about their potential, we now have concluded that none would provide a true incremental benefit for patients compared to medicines currently on the market - and therefore do not warrant further development. We had hoped to provide you with this information in an in-person meeting.
Assessing this setback in the context of our overall Virology Disease Area, we have decided to refocus our resources within Virology on diseases in which we can deliver substantial improvements over existing medicines. However, when we identify a significant scientific breakthrough in HIV externally, we would certainly assess our ability to make a further contribution to the field, as we did with Fuzeon.
Developing new treatments for viral diseases continues to be a priority.
In particular, we have a promising pipeline of new drugs for the treatment of hepatitis C, which is one of the most significant causes of mortality among patients living with HIV. Furthermore, our scientists are currently examining a range of other viral diseases to determine those which offer the potential for us to make a difference.
Roche will, of course, continue to support our medicines that are currently available for the treatment and monitoring of HIV-related disease, including Fuzeon, Invirase and Viracept, as well as our molecular diagnostic tests. In addition, we remain committed to increasing the access to our HIV medicines for people living with HIV in resource-limited countries with programmes such as our preferential patent and pricing policy and the AIDS Technology Transfer Initiative.
Sincerely,
Jenny Edge-Dallas
Global Leader, HIV Franchise
Mike Nelson,
International Communications Manager, Hepatitis and HIV
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