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    <recommendedItem id="20100101_19_344"
                     title="FDA Revises HIV Drug Label for Liver Complication"
                     score="0.009"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18229?impressionId=1265777533138"
                     
      &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="-0.002"
                     href="http://www.medpagetoday.com/HIVAIDS/HIVAIDS/tb/18071?impressionId=1265777533138"
                     
      &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=1265777533138"
                     
      &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_2291"
                     title="IAS: Circumcision May Lower HIV Risk in Male-Male Sex"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/IAS/tb/15167?impressionId=1265777533138"
                     
      CAPE TOWN, South Africa, July 21 -- Researchers here suggested that circumcision may exert a protective role among men who have sex with men.
              &lt;p&gt; 
              &lt;p&gt;In a presentation at the International AIDS Society meeting here, doctors said the findings, developed using data from other trials, indicate that circumcision lowers the risk of infection with human immunodeficiency virus (HIV) for men who practice insertive anal intercourse or receptive anal intercourse nearly exclusively.
              &lt;p&gt; 
              &lt;p&gt;However, Tim Lane, PhD, MPH, assistant professor of medicine at the Center for AIDS Prevention Studies at the University of California San Francisco, said a clinical trail to prove the effectiveness of circumcision will be required.
              &lt;p&gt; 
              &lt;p&gt;&quot;The acceptability and ethical implications of male circumcision in the men who have sex with men must be assessed prior to initiating clinical trials,&quot; Dr. Lane said in his poster discussion session.
              &lt;p&gt; 
              &lt;p&gt;He said the risk of an uncircumcised man who practiced insertive sex with other men was 4.5 times higher than a circumcised man who practiced insertive sex with other men (95% CI 3.1 to 6.7).
              &lt;p&gt; 
              &lt;p&gt;A circumcised man who practiced receptive sex with other men had a nonsignificant 1.4-times greater risk of HIV infection than circumcised men who practiced insertive sex.
              &lt;p&gt; 
              &lt;p&gt;Uncircumcised men who practiced receptive sex with other men were at 7.5 times the risk of HIV infection than circumcised men who practiced insertive sex (95% CI 4.9 to 11.5).
              &lt;p&gt; 
              &lt;p&gt;In the population studied (Soweto, South Africa), the vast majority of men who had sex with men practiced either insertive or receptive sex exclusively, Dr. Lane said.
              &lt;p&gt; 
              &lt;p&gt;&quot;Only 14% of the men said they practice both insertive and receptive sex,&quot; he said. &quot;About 40% of the men said they also had sex with women.&quot;
              &lt;p&gt; 
              &lt;p&gt;For the responder-driven study, researchers recruited 363 men who lived in Soweto between February and August 2008.
              &lt;p&gt; 
              &lt;p&gt;The men completed a one-time behavioral survey, which asked for particular detail on their sexual behavior with their five most recent partners in the previous six months.
              &lt;p&gt; 
              &lt;p&gt;&quot;This study may open the door for other studies,&quot; said Naomi Block, MD, medical officer for the Global AIDS Program at the CDC.
              &lt;p&gt; 
              &lt;p&gt;She suggested that the study comes with caveats that could impact its generalizability. Among them are the self-reported activity of the participants and the finding that most said they engage in either receptive or insertive sex.
              &lt;p&gt; 
              &lt;p&gt;&quot;Other groups of men outside of Soweto may not have such specific sexual habits,&quot; she said.
              &lt;p&gt; 
              &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;The Soweto Men&apos;s Study was supported by the National Institute of Mental Health, the Peninsula Community Foundation Hurlbut Johnson Fund, and the USCF Research Institute Jesse Miller Memorial Fund and USAID/PEPFAR.
              &lt;p&gt;The researchers did not disclose any financial conflicts. The International AIDS Society does not require financial disclosures.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
             
    </recommendedItem>
    <recommendedItem id="20090101_6_165"
                     title="IAC: Jury Out on Heterosexual HIV Risk"
                     score="-0.005"
                     href="