<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_344"
                     title="FDA Revises HIV Drug Label for Liver Complication"
                     score="0.008"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18229?impressionId=1265744161738"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has updated labels of the HIV drug didanosine (Videx and Videx EC) to include warnings for potentially serious liver damage.&lt;/p&gt;
&lt;p&gt;Although these cases are rare, the drug may cause noncirrhotic hypertension in patients, a potentially fatal complication which the FDA discovered through 42 postmarket, adverse event reports.&lt;/p&gt;
&lt;p&gt;Of those patients, three required liver transplant and four died. Two deaths were caused by esophageal hemorrhage, while two more were caused by progressive liver failure.&lt;/p&gt;
&lt;p&gt;One patient suffered multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis.&lt;/p&gt;
&lt;p&gt;The FDA said in a statement that it chose not to recall the drug because it believes its benefits outweigh potential risks, but advised that treatment decisions be made on an individual basis between healthcare professionals and patients.&lt;/p&gt;
&lt;p&gt;The agency added that causal association is difficult to determine in postmarket reports, but that alternative causes of the hypertension were ruled out in well-documented cases.&lt;/p&gt;
&lt;p&gt;Healthcare professionals who determine didanosine is effective in treating a patient should monitor that patient for the development of portal hypertension and esophageal varices, the agency said.&lt;/p&gt;
&lt;p&gt;Didanosine is used in combination with other HIV medications to help maintain CD4 cells in patients.&lt;/p&gt;
&lt;p&gt;The drug already has a black box warning for lactic acidosis and hepatomegaly with steatosis.&lt;/p&gt;
&lt;p&gt;Like the antiretroviral agents hydroxyurea and ribavirin, didanosine has been associated with the development of liver toxicity.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_217"
                     title="Herpes Therapy Doesn&apos;t Bar HIV Transmission (CME/CE)"
                     score="-0.003"
                     href="http://www.medpagetoday.com/HIVAIDS/HIVAIDS/tb/18071?impressionId=1265744161738"
                     
      &lt;p&gt;Treating herpes has no effect on the transmission of HIV among discordant couples, researchers said.&lt;/p&gt;
&lt;p&gt;The lack of efficacy was found in a large, randomized clinical trial despite significant reductions in HIV viral load among those treated for herpes simplex-2 (HSV-2), according to Connie Celum, MD, of the University of Washington, and colleagues.&lt;/p&gt;
&lt;p&gt;Researchers will have to look for new ways to prevent transmission among discordant couples (in which one partner has HIV and the other does not), Celum and colleagues concluded online in the&lt;em&gt; New England Journal of Medicine.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The study comes after earlier trials also showed that treating HSV-2 with the antiviral acyclovir (Zovirax) did not lower the risk of getting HIV. (See &lt;a href=&quot;http://www.medpagetoday.com/HIVAIDS/HIVAIDS/9884&quot; mce_href=&quot;http://www.medpagetoday.com/HIVAIDS/HIVAIDS/9884&quot; target=&quot;_blank&quot;&gt;Herpes Treatment No Help in Preventing HIV&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;The trials  --  and the current study  --  had their origins in epidemiological and laboratory observations that having an HSV-2 infection increased the risk of contracting HIV.&lt;/p&gt;
&lt;p&gt;Researchers reasoned that a converse effect might also be true  --  treating HSV-2 in HIV-negative people might reduce their risk of infection.&lt;/p&gt;
&lt;p&gt;The reasoning was bolstered by clinical trials showing that treating HSV-2 in HIV-positive people lowered their viral load.&lt;/p&gt;
&lt;p&gt;In the current study, that effect also occurred. HIV-positive volunteers treated with acyclovir saw, on average, a reduction in plasma concentration of HIV by 0.25 log&lt;sub&gt;10&lt;/sub&gt; copies per milliliter compared with members of the placebo group. The difference was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001.&lt;/p&gt;
&lt;p&gt;But transmission among the couples was not affected, implying that a greater reduction in viral load is needed, the researchers said.&lt;/p&gt;
&lt;p&gt;The study, randomized and placebo-controlled, included 3,408 couples in Africa in which only one of the partners had HIV (but was not taking antiretroviral therapy) and also had an HSV-2 infection.&lt;/p&gt;
&lt;p&gt;The outcome was first reported at the Cape Town meeting of the International AIDS Society last year (See &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/IAS/15242&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/IAS/15242&quot; target=&quot;_blank&quot;&gt;IAS: Acyclovir Flops in Preventing HIV Transmission&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;The primary outcome was transmission between partners, verified by genetic sequencing of the virus.&lt;/p&gt;
&lt;p&gt;Transmission between partners was verified in 84 of the 132 recorded cases of transmission, the researchers said, and they were evenly divided  --  41 among those getting the drug and 43 in the placebo group.&lt;/p&gt;
&lt;p&gt;On the other hand, the use of the drug reduced the occurrence of herpes lesions by 73%, which was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001.&lt;/p&gt;
&lt;p&gt;The reduction of herpes lesions suggests that the drug was being used, the researchers said, and therefore that the lack of efficacy against HIV was not a result of nonadherence to acyclovir.&lt;/p&gt;
&lt;p&gt;Overall, the rate of HIV transmission in the study was 2.7 cases per 100 person-years, markedly lower than earlier observations. The researchers attributed that to such interventions as monthly counseling on risk reduction and free condoms.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study had support from the Bill and Melinda Gates Foundation, as well as the University of Washington, the National Institute of Allergy and Infectious Diseases, Gen-Probe, and the National Institute of Mental Health.&lt;/p&gt;&lt;p&gt;Celum reported financial links with GlaxoSmithKline and several other authors reported links with various pharamceutical companies.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_205"
                     title="Slim Evidence for Effect of Home Care on HIV Treatment (CME/CE)"
                     score="-0.003"
                     href="http://www.medpagetoday.com/HIVAIDS/HIVAIDS/tb/18037?impressionId=1265744161738"
                     
      &lt;p&gt;Home-based care can improve some aspects of HIV treatment, according to a systematic review of reported studies.&lt;/p&gt;
&lt;p&gt;But the evidence is slim, and no studies looked at how home-based care affects AIDS progression or death, according to Taryn Young, MBChB, of the Medical Research Council of South Africa, and Karishma Busgeeth of the Council for Scientific and Industrial Research in Pretoria, South Africa.&lt;/p&gt;
&lt;p&gt;In addition, few of the studies evaluated home-based care in developing countries, where it is being considered to alleviate pressure on hospitals, the researchers noted in a &lt;em&gt;Cochrane Systematic Review&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Home-based care is aimed at improving quality of life and reducing the need for hospital care, &quot;especially where public health services are overburdened,&quot; the researchers wrote in the review.&lt;/p&gt;
&lt;p&gt;But there has been no systematic evaluation of home-based care in the setting of HIV/AIDS, they said.&lt;/p&gt;
&lt;p&gt;To help fill the gap, they found 13 published reports, referring to 11 randomized clinical trials, as well as two such trials currently under way.&lt;/p&gt;
&lt;p&gt;Of the 11 studies with published reports, 10 randomized individuals and one (in Uganda, the only one conducted in Africa) randomized households.&lt;/p&gt;
&lt;p&gt;The studies looked at a range of interventions: &lt;ul&gt; &lt;li&gt;Three studies evaluated home-based intensive nursing versus standard care for effects on patient knowledge of HIV and related medication, adherence, viral load, and CD4 counts.&lt;/li&gt; &lt;li&gt;Two studies compared a transprofessional team versus an independent primary care nurse. One looked at quality of life and survival and the other at the time patients spent in the program, as well as cost.&lt;/li&gt; &lt;li&gt;Two studies compared the effect of computer-based education versus brochures, nothing, or standard medical care on such outcomes as perceived social isolation, decision-making confidence, health status, quality of life, risk behaviors, and health service utilization.&lt;/li&gt; &lt;li&gt;Two studies looked at exercise.&lt;/li&gt; &lt;li&gt;One study looked at two months of home total parenteral nutrition versus dietary counseling.&lt;/li&gt; &lt;li&gt;One study of diarrhea compared home-based water chlorination, safe storage, and education with education alone.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The researchers reported that intensive home-based nursing significantly improved self-reported knowledge of HIV and medications, self-reported adherence, and differences in pharmacy drug refills.&lt;/p&gt;
&lt;p&gt;Another study, which looked at the proportion of participants with greater than 90% adherence, found statistically significant differences over time with home-based nursing. But that study found no significant change in CD4 counts and viral loads.&lt;/p&gt;
&lt;p&gt;The third such study found significant differences in HIV stigma, worry, and physical functioning but no differences in depressive symptoms, mood, general health, and overall functioning.&lt;/p&gt;
&lt;p&gt;The studies comparing comprehensive case management by transprofessional teams compared to usual care by primary care nurses showed no effect.&lt;/p&gt;
&lt;p&gt;The study comparing home total parenteral nutrition and dietary counseling found no significant impact on overall survival and rate of readmission to hospital.&lt;/p&gt;
&lt;p&gt;The two computer-based studies found no effect on health status and decision-making confidence and skill, but did find a reduction in social isolation after controlling for depression.&lt;/p&gt;
&lt;p&gt;The two trials evaluating home exercise programs found conflicting results.&lt;/p&gt;
&lt;p&gt;And the home-based safe water systems reduced diarrhea frequency and severity among persons with HIV in Africa, the researchers reported.&lt;/p&gt;
&lt;p&gt;In general, the researchers concluded that there were few studies; study populations tended to be small; and the studies did not address the effect of home-based care on important medical endpoints, such as mortality.&lt;/p&gt;
&lt;p&gt;&quot;Further large studies should therefore focus on evaluating these significant endpoints, on feasible interventions for developing countries, and on how home-based care fits into the current treatment context,&quot; they concluded.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;There was no external support for the study. The researchers reported no conflicts.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_2317"
                     title="IAS: Raltegravir Sustains High-level Efficacy in HIV Trial"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/IAS/tb/15201?impressionId=1265744161738"
                     
      CAPE TOWN, South Africa, July 22 -- The integrase inhibitor raltegravir (Isentress) appeared to be as effective with HIV patients as the standard treatment based on efavirenz (Sustiva), researchers reported here.
              &lt;p&gt;
              &lt;p&gt;More than 75 percent of patients on each regimen maintained suppression of human immunodeficiency virus after nearly three years of treatment. There were also hints that raltegravir was better tolerated than efavirenz, a non-nucleoside reverse transcriptase inhibitor, according to Bach-Yen Nguyen, MD, senior director at Merck Research Laboratories. 
              &lt;p&gt;
              &lt;p&gt;&quot;At 144 weeks, raltegravir had sustained antiretroviral effect similar to 96 week data and similar to efavirenz,&quot; Dr. Nguyen reported at the 2009 International AIDS Society conference on pathogenesis, treatment, and prevention of HIV.
              &lt;p&gt; 
              &lt;p&gt;All the patients in the study were antiretroviral-naïve at the outset. Both groups were also receiving the nucleotide reverse transcriptase inhibitor tenofovir (Viread) and the nucleoside reverse transcriptase inhibitor lamivudine (Epivir).
              &lt;p&gt; 
              &lt;p&gt;In her presentation, Dr. Nguyen said that after 144 weeks of therapy, 78% of the 160 patients on the raltegravir-based regimen maintained viral suppression at a level that was undetectable using the 50 copies/ml assay. 
              &lt;p&gt; 
              &lt;p&gt;About 76% of the 38 patients in the efavirenz group had maintained undetectable viral loads after about three years on medication.
              &lt;p&gt;
              &lt;p&gt;&quot;We are encouraged that these data demonstrate the efficacy and tolerability profile of raltegravir with less effect on lipid levels for up to 144 weeks,&quot; said Martin Markowitz, MD, clinical director of the Aaron Diamond AIDS Research Center, New York, New York, and one of the study&apos;s researchers.
              &lt;p&gt;
              &lt;p&gt;&quot;It is important for patients at any stage of HIV to have treatment options that are effective and have a demonstrated tolerability profile in order to help them manage their disease.&quot;
              &lt;p&gt;
              &lt;p&gt;On July 8, raltegravir was approved by the U.S. Food and Drug Administration for use in treatment-naïve adult patients in combination with other antiretroviral medicines for the treatment of HIV-1 infection. 
              &lt;p&gt;
              &lt;p&gt;The use of raltegravir in treatment-naïve patients is investigational in other countries throughout the world.
              &lt;p&gt;
              &lt;p&gt;&quot;The long-term success of raltegravir in maintaining viral suppression gives us another option in treatment,&quot; said Stefano Vella, MD, director of the Department of Therapeutic Research and Medicines Evaluation at the Istituto Superiore di Sanita, Rome, Italy. 
              &lt;p&gt;
              &lt;p&gt;However, Dr. Vella said that &quot;in this era of non-inferiority trials, I would like to see studies that indicated that not only was treatment non-inferior, but also offered something else -- perhaps a quality of life difference for the patients. Are the patients happier with this new treatment?&quot;
              &lt;p&gt;
              &lt;p&gt;These 144-week findings are from an ongoing multi-center, dose-ranging, double-blind, randomized trial of previously untreated HIV-infected adult patients. 
              &lt;p&gt;
              &lt;p&gt;In this study, 198 treatment-naïve, HIV-infected patients received either raltegravir administered orally twice daily in combination with tenofovir and lamivudine, or 600 mg of efavirenz dosed orally once daily in combination with the same agents.
              &lt;p&gt;
              &lt;p&gt;During the first 48 weeks of the study, patients were randomized to one of four dose regimens of raltegravir (100, 200, 400, 600 mg twice daily). After 48 weeks, all raltegravir groups received 400 mg dosed twice daily.
              &lt;p&gt;
              &lt;p&gt;Patients on both treatment regimens experienced increases in CD4 cell counts. At 144 weeks, the mean increase from baseline in CD4 cell count was 252 cells/mm3 for raltegravir patients and 233 cells/mm3 for patients receiving the regimen containing efavirenz.
              &lt;p&gt;
              &lt;p&gt;Both drugs were generally well tolerated, with cumulative rates of drug-related clinical adverse experiences less frequent in the regimen containing raltegravir. 
              &lt;p&gt;
              &lt;p&gt;About 54% of the raltegravir patients had adverse side effects compared with 76% of the efavirenz patients. Malignancy rates were about equal. 
              &lt;p&gt;
              &lt;p&gt;Raltegravir had less effect on total or low density lipoprotein cholesterol or triglycerides.
              &lt;p&gt;
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;Dr. Nguyen is an employee of Merck, which sponsored the study.
              &lt;p&gt; 
              &lt;p&gt;Dr. Markowitz and Dr. Vella did not report financial relationships. The IAS does not require presenters to list commercial or other financial relationships.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
        
    </recommendedItem>
    <recommendedItem id="20090101_3_843"
                     title="IAC: The Grim Days Recalled as AIDS Hits 25"
                     score="-0.005"
                     href="