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(CROI) took place in Boston from February update of the STARTMRK study at CROI.
27 to March 2, 2011. CROI is a scientifically- The study is comparing twice-daily raltegravir researchers working to understand, prevent, and treat HIV/AIDS and its complications. science-packed days of lectures, symposia, were slightly more drug-related side effects and presentations, and was attended by 4,000 LVVXHBOLY SR] PDJT[G   30 3DJH  regimens for people below 250 copies/ml, but instead The QDMRK study, comparing once-daily versus twice- testing again monthly to ensure that they’re stable. daily raltegravir, found that the once-daily dosing wasless effective, with more resistance and more failures t han twice-daily dosing. As a result, t his study was The Berlin patient, described in issue 71 (March/April discontinued and participants all went to the twice-daily 2011), is a 40-year-old HIV-positive man who received a bone marrow transplant to treat acute myeloid leukemia.
Another study, Mono-PI: DRV/RT V, compared once- During the procedure, his own immune system was daily dosing versus twice-daily dosing of darunavir destroyed and replaced with stem cells from a donor (Prezista) with ritonavir (Nor vir) over 96 weeks. Treat- who had the ver y rare CCR5-delta32 mutation. As a ment failures occurred af ter participants were switched result, he appears to be cured of HIV and currently has from a twice-daily dose to a once-daily dose. an undetectable viral load, even though he’s no longertaking HAART.
A US company is using a genetic engineering The 48-week update of a trial comparing a three-drug approach to disrupt the CCR5. Once CD4 cells are antiretroviral therapy versus a f ive-drug hypertherapy removed from people, the cells are treated to mimic the revealed no difference between the two therapies. This CCRD-delta32 mutation and are then put back into the study def initively shows that triple therapy is as good as same person. This new experimental therapy was success- it gets—there’s no need to add the extra two drugs. ful in the f irst few test subjects: the procedure was well Several trials testing different roles for maraviroc tolerated and CD4 counts increased. This is an exciting (Celsentri) didn’t demonstrate strong evidence to add a development, but still in the early stages. fourth drug to the antiretroviral regimens. To address the many concerns about cardiovascular Dr. Montaner provided some of the latest results from problems with abacavir (Ziagen), the US Food and Drug the HPTN 052 study ( This study examined Administration conducted a detailed statistical analysis HIV transmission in 1,750 sero-discordant couples. The comparing the results from all abacavir trials. The HIV-positive partner either received highly active anti- results showed once and for all that there’s no increased retroviral therapy (HAART) immediately or deferred treatment. In the couples where the poz partnerreceived immediate HAART, the HIV transmission rate was reduced by 96.3 percent. Because this group had lower transmission than the group that received deferred The 96-week update of the ANRS 139 TRIO study demonstrates that the combination of raltegravir plus Dr. Montaner emphasized again how treating ever y- etravirine (Intelence) and darunavir (Prezista) boosted one diagnosed with HIV reduces disease progression, with ritonavir provides a high rate of virologic suppression reduces death, and prevents transmission. He discussed in treatment-experienced people with multiple-drug additional results that support the treatment-as-prevention resistant HIV. They maintained virologic suppression approach. He also noted that the World Health Organization is going to make an announcement recommending that treatment as prevention be offered regardless of a Dr. Montaner is still not satisf ied with the TaqManAssay, which is being used to determine viral load, asit’s been giving inaccurate results. Using this assay, heconsiders the threshold of 250 copies/ml as the clinicalthreshold for failure. He recommends carefully monitor-ing patients with viral loads over 50 copies/ml, and recommends repeating the test more frequently. Dr.
Montaner doesn’t recommend switching treatment


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The Australian Sports Drug Medical Advisory Committee (ASDMAC) processes Therapeutic Use Exemptions (TUE). These exemptions give permission to athletes who, for medical (therapeutic) reasons, need to use medications or methods that are prohibited in sport. The World Anti-Doping Agency’s (WADA) 2010 List of Prohibited Substances includes a change of status to the therapeutic use of inhale

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FOR IMMEDIATE RELEASE Contact: Kimberly Kraemer Corporate Communications 510-450-3500 ADAMAS PHARMACEUTICALS ANNOUNCES SUCCESSFUL END-OF-PHASE 2 MEETING WITH FDA FOR ARIMENDATM EMERYVILLE, CALIF., May 15, 2012 – Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has held an End-of-Phase 2 meeting with the FDA to discuss the proposed safety a

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