HIV-related Memory Loss Linked To Alzheimer's Protein

New research published in Neurology suggests that amyloid, one of the proteins associated with Alzheimer's disease, may also play a role in the memory loss of people with HIV.

Researchers examined cerebrospinal fluid (CSF) and found that the amount of amyloid was lower in Alzheimer's patients and HIV patients with memory problems, when compared to HIV patients without memory problems and healthy people. The other protein associated with Alzheimer's, Tau, was unchanged. Lower amounts of amyloid in the CSF suggest that amyloid processing in the brain is also affected.

'Alzheimer's like symptoms experienced by people with HIV can be frightening and confusing but this research builds on our understanding of why these symptoms occur and may help people get a more accurate diagnosis.

'Using spinal fluid techniques to diagnose dementia adds great value to research yet the UK lags far behind other countries who routinely use them. We must invest more in dementia research and increase the use of spinal fluid techniques if the UK is to lead the fight against dementia.'

Dr Susanne Sorensen
Head of Research

Source
Alzheimer's Society

Hospital-Acquired HIV In Africa

PlusNews examines several recent reports that highlight how unsanitary hospital procedures can create an environment conducive to the spread of HIV/AIDS.

"One study of HIV-positive Swazi children aged between 2 and 12, which relied on data from the 2006-2007 Swaziland Demographic and Health Survey, found that one in five of the children had HIV-negative mothers. Discounting the possibility that child sexual abuse could account for such a significant share of paediatric infections, the authors suggested that contaminated needles used to administer vaccinations and injections were to blame," the news service writes. "This argument was supported by evidence from a Kenyan study, which found that HIV-infected children with HIV-negative mothers had experienced more potential blood exposures during malaria treatment, dental surgery and vaccinations than their uninfected siblings."

The news service continues: "Another study in the journal published by the British Association of Sexual Health and HIV, found that clients at voluntary HIV counselling and testing centres run by the University of Calabar Teaching Hospital in southeastern Nigeria, who contracted HIV, were significantly more likely to have had blood tests, vaccinations, blood transfusions or surgical procedures than those who remained negative."

The article includes comments by study researchers, who say HIV prevention programs should improve blood screening and equipment sterilization in addition to addressing sexual behavior, and outside experts who say the studies raise interesting questions, but warn that more research is needed to fully grasp the extent of the problem (12/7).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Medicare Expands List Of Covered Preventive Services To Include HIV Screening Tests

The Centers for Medicare & Medicaid Services (CMS) today announced its final decision to cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service. The decision is effective immediately.

Under the recently passed Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS now has the flexibility of adding to Medicare's list of covered preventive services, if certain requirements are met. Prior to this law, Medicare could only cover additional preventive screening tests when Congress authorized it to do so.

"Today's decision marks an important milestone in the history of the Medicare program," said HHS Secretary Kathleen Sebelius. "Beginning with expanding coverage for HIV screening, we can now work proactively as a program to help keep Medicare beneficiaries healthy and take a more active role in evaluating the evidence for preventive services."

Under MIPPA, CMS can consider whether Medicare should cover preventive services that Congress has not already deemed as covered or non-covered by law. Among other requirements, the new services must have been "strongly recommended" or "recommended" by the U.S. Preventive Services Task Force. For instance, the Task Force graded HIV screening as "strongly recommended" for certain groups. More information about the Task Force is available online here.

"Every adult should know their HIV status," said Dr. Howard K. Koh, HHS assistant secretary for health. "This decision by Medicare should help promote screening and save lives."

CMS uses the national coverage determination (NCD) process to make decisions on these types of preventive services. This process provides transparency about the evidence that CMS considers when making its decisions and allows opportunity for the public to comment on CMS' proposals.

"Medicare's coverage of HIV screening tests is an important step forward in protecting beneficiaries from the potentially devastating and life-threatening complications of HIV and Acquired immunodeficiency Syndrome (AIDS)," said CMS Acting Administrator Charlene Frizzera.

AIDS is diagnosed when an HIV-infected person's immune system becomes severely compromised or a person becomes ill with an HIV-related infection. Of the more than one million estimated to have the HIV infection, the Centers for Disease Control and Prevention has estimated that about a quarter of them do not realize they are infected. Without treatment, AIDS develops within 8 to 10 years. While there is presently no cure for HIV, screening can help identify infected patients so that they can receive medical treatment that could help delay the onset of AIDS for years.

More information about Medicare's new HIV screening benefit is available in CMS' final decision memorandum. Read the final decision online here.

Source
HHS

Pharma manufacturers have 97 new HIV/AIDS medications in the pipeline

Chemistry World recently highlighted a new report published by the Pharmaceutical Research and Manufacturers of America (PhRMA) that identifies 97 new drugs and vaccines in development for HIV/AIDS and related conditions.

The report found that the 97 products in development include 23 vaccines and 54 antivirals. These drugs are either in human clinical trials or awaiting approval by the U.S. Food and Drug Administration (FDA).

"We are greatly encouraged by these critically important medicines and vaccines in development to treat and prevent HIV infection," said PhRMA President and CEO Billy Tauzin. "Pharmaceutical researchers are continuing their efforts to develop new therapies and vaccines to improve and lengthen the lives of HIV-infected patients."

"As a result of HIV/AIDS medicines, a disease that was once a virtual death sentence can now be controlled and treated as if it were a chronic disease," stated Tauzin. "And the new medicines our scientists are working on right now bring hope for even more promising results in the future."

December 1 marks the 21st anniversary of "World AIDS Day" - a global awareness campaign that originated at the 1988 World Summit of Ministers of Health on Programmes for AIDS Prevention.

Source: Pharmaceutical Research and Manufacturers of America

Chinese AIDS activists demand more access to treatment

A small group of uninvited Chinese activists took over an official World AIDS Day event Tuesday, demanding more government recognition and help.

The action at the Chinese railway's massive South Station in Beijing came as volunteers passed out AIDS leaflets to passengers as part of a campaign by China's Red Cross.

Wearing white face masks scrawled with the words "Infected blood transfusions causes AIDS," the group or 20 or so activists mounted the stage to speak through tears.

"Our fight for free treatment has continued for the past eight years with no luck," one protester, Liu Xiurong, said afterward.

Liu, from northern Harbin, said her son became infected with the HIV virus by tainted plasma several years ago. She received compensation from the Shanghai company that supplied the blood but the money wasn't enough to help her family with its medical costs.

"The money we got is not even close to the amount that we need to live. My son still needs treatment," she told Associated Press Television News.

"Now that we've put ourselves out there, there is a chance that we'll be beaten or arrested in the future," Liu said. "It's OK because we have nothing left to lose and maybe by doing this, we can inspire others who are afraid to come out united for our cause."

The HIV virus that causes AIDS gained a foothold in China largely due to unsanitary blood plasma-buying schemes and tainted transfusions in hospitals.

AIDS was the top killer among infectious diseases in China for the first time last year, a fact that may reflect improved reporting of HIV/AIDS statistics in recent years as the country slowly acknowledges the problem.

By the end of October, the number of Chinese confirmed with HIV-AIDS was 319,877, according to China's Health Ministry, up from 264,302 last year and 135,630 in 2005. Health Minister Chen Zhu said the actual level of infections is probably closer to 740,000.

On Monday, President Hu Jintao publicly pledged to mobilize the whole society in tackling the growing AIDS problem in the China.

State broadcaster China Central Television showed footage Tuesday of Hu, wearing a crimson ribbon pinned to his shirt, talking through a videophone to AIDS patients, doctors and researchers at Ditan Hospital. It was a move aimed at improving awareness and helping reduce stigma for HIV-positive people.

On Tuesday, dozens of railway workers and about 100 volunteers, some with stickers of a red ribbon or a red cross on their cheeks, helped pass out free pamphlets on disease prevention and reducing social stigma. Free condoms were also available to passers-by.

The event, co-hosted by the Railways Ministry, was aimed at promoting AIDS and HIV messages on the country's massive rail network to target the public, in particular migrant workers who crisscross the country in search of jobs.

Globally, there were about 33.4 million people with HIV last year, according to UNAIDS in a report issued last week. About 4.7 million of those were in the Asia-Pacific region.

There were about 350,000 new infections last year across the Asia-Pacific, including 21,000 children. And about 330,000 people died from complications related to AIDS.

The epidemic continues to be fueled in most countries by high-risk groups, such as intravenous drug users, sex workers and their clients. Though China is believed to have the world's largest number of injecting drug users, the main mode of HIV transmission has changed from infected needles from drug use to heterosexual sex.

Data show that 40 percent of new HIV cases diagnosed in China were infected through heterosexual contact, with homosexual sex accounting for 32 percent and the remainder related to drug abuse.

_____

Associated Press Medical Writer Margie Mason in Hanoi contributed to this report.

Important Label Update for Norvir (Ritonavir)

November 23, 2009

On November 23, 2009, FDA approved changes to the Norvir package insert (product label) to include drug-drug interaction information for concurrent ritonavir administration with:

• inhaled medicines such as salmeterol or salmeterol in combination with fluticasone propionate (Serevent, Advair)
• sildenafil (Revatio)

Also other revisions to the Contraindications, Warnings, Precautions: Drug Interactions and Dosage and Administration as follows.

The CONTRAINDICATIONS was updated as follows:
When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information.
NORVIR is contraindicated in patients with known hypersensitivity to ritonavir or any of its ingredients.
Co-administration of NORVIR is contraindicated with the drugs listed in Table 4 (also see PRECAUTIONS -- Table 5. Drugs that Should Not be Co-administered with NORVIR) because ritonavir mediated CYP3A inhibition can result in serious and/or life-threatening reactions. Voriconazole and St. John's Wort are exceptions in that co-administration of NORVIR and voriconazole results in a significant decrease in plasma concentrations of voriconazole, and co-administration of NORVIR with St. John's Wort may result in decreased ritonavir plasma concentrations.

Table 4. Drugs that are Contraindicated with NORVIR
Drug Class	Drugs Within Class That Are CONTRAINDICATED With NORVIR**
Alpha1-adrenoreceptor antagonist	Alfuzosin HCL
Antiarrhythmics	Amiodarone, bepridil, flecainide, propafenone, quinidine
Antifungal	Voriconazole
Ergot Derivatives	Dihydroergotamine, ergonovine, ergotamine, methylergonovine
GI Motility Agent	Cisapride
Herbal Products	St. John's Wort (hypericum perforatum)
HMG-CoA Reductase Inhibitors:	Lovastatin, simvastatin
Neuroleptic	Pimozide
PDE5 enzyme inhibitor	Sildenafil* (Revatio®) only when used for the treatment of pulmonary arterial hypertension (PAH)
Sedative/hypnotics	Oral midazolam, triazolam
* see WARNINGS - Drug Interactions and PRECAUTIONS -- Table 6. Established and Other Potentially Significant Drug Interactions for coadministration of sildenafil in patients with erectile dysfunction. ** For additional information for these contraindicated drugs, see also PRECAUTIONS -- Table 5. Drugs that Should Not be Co-administered with NORVIR.

The WARNINGS section for Drug Interactions was updated as follows
Drug Interactions
See CONTRAINDICATIONS- Table 4 for a listing of drugs that are contraindicated with NORVIR due to potentially life-threatening adverse events, significant drug interactions, or loss of virologic activity. Also, see PRECAUTIONS -- Table 5 and Table 6 for drugs that should not be co-administered with NORVIR and for a listing of drugs with established and other significant drug interactions.

The PRECAUTIONS section with regard to drug interactions was updated as follows:

Table 5. Drugs that Should Not be Co-administered with NORVIR
Drug Class: Drug Name	Clinical Comment
Alpha Adrenergic Antagonist: alfuzosin	CONTRAINDICATED due to potential for serious reactions such as hypotension.
Antiarrhythmics: amiodarone, bepridil, flecainide, propafenone, quinidine	CONTRAINDICATED due to potential for serious and/or life threatening reactions such as cardiac arrhythmias.
Antifungal: voriconazole	CONTRAINDICATED due to significant decreases in voriconazole plasma concentrations and may lead to loss of antifungal response.
Ergot Derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine	CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system.
GI Motility Agent: cisapride	CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Herbal Products: St. John's wort (hypericum perforatum)	CONTRAINDICATED as the combination may lead to loss of virologic response and possible resistance to NORVIR or to the class of protease inhibitors.
HMG-CoA Reductase Inhibitors: lovastatin, simvastatin	CONTRAINDICATED due to potential for serious reactions such as risk of myopathy including rhabdomyolysis.
Neuroleptic: pimozide	CONTRAINDICATED due to the potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
PDE5 enzyme inhibitor: Sildenafil* (Revatio®)	CONTRAINDICATED in the treatment of pulmonary arterial hypertension (PAH). A safe and effective dose has not been established when used with ritonavir. There is an increased potential for sildenafil-associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope.
Sedative/hypnotics: oral midazolam, triazolam	CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.

Table 6 below was revised to include updated information on coadministration with darunavir, tipranavir, maravoric, voriconazole, PDE5 inhibitor for pulmonary arterial hypertension (sildenafil (Revatio)) and parenteral midazolam

Table 6. Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen Recommended Based on Drug Interaction Studies or Predicted Interaction (see CLINICAL PHARMACOLOGY -- Table 2 and Table 3 for Magnitude of Interaction)
Concomitant Drug Class: Drug Name	Effect on Concentration of Ritonavir or Concomitant Drug	Clinical Comment
HIV-Antiviral Agents
HIV Protease Inhibitor: darunavir	When co-administered with reduced doses of ritonavir ↑ darunavir (↑ AUC, ↑ Cmax, ↑ Cmin)	See the complete prescribing information for Prezista® (darunavir) for details on co-administration of darunavir 600 mg b.i.d with ritonavir 100 mg b.i.d. or darunavir 800 mg q.d. with ritonavir 100 mg q.d.
HIV Protease Inhibitor: tipranavir	When co-administered with reduced doses of ritonavir ↑ tipranavir (↑ AUC, ↑ Cmax, ↑ Cmin)	See the complete prescribing information for Aptivus® (tipranavir) for details on co-administration of tipranavir 500 mg b.i.d with ritonavir 200 mg b.i.d. There have been reports of clinical hepatitis and hepatic decompensation including some fatalities. All patients should be followed closely with clinical and laboratory monitoring, especially those with chronic hepatitis B or C co-infection, as these patients have an increased risk of hepatotoxicity. Liver function tests should be performed prior to initiating therapy with tipranavir/ritonavir, and frequently throughout the duration of treatment.
HIV Protease Inhibitor: fosamprenavir	When co-administered with reduced doses of ritonavir ↑ amprenavir (↑ AUC, ↑ Cmax, ↑ Cmin)	See the complete prescribing information for Lexiva® (fosamprenavir) for details on co administration fosamprenavir 700 mg b.i.d with ritonavir 100 mg b.i.d., fosamprenavir 1400 mg q.d. with ritonavir 200 mg q.d. or fosamprenavir 1400 mg q.d. with 100 mg q.d.
HIV CCR5 -- antagonist: maraviroc	↑ maraviroc	Concurrent administration of maraviroc with ritonavir will increase plasma levels of maraviroc. For specific dosage adjustment recommendations, please refer to the complete prescribing information for Selzentry® (maraviroc).
Other Agents
Antifungal: voriconazole	↓ voriconazole	Coadministration of voriconazole and ritonavir doses of 400 mg every 12 hours or greater is contraindicated. Coadministration of voriconazole and ritonavir 100 mg should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Long-acting beta-adrenoceptor agonist: salmeterol	↑ salmeterol	Concurrent administration of salmeterol and ritonavir is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
PDE5 Inhibitors: sildenafil, tadalafil, vardenafil	↑ sildenafil ↑ tadalafil ↑ vardenafil	Particular caution should be used when prescribing sildenafil, tadalafil or vardenafil in patients receiving ritonavir. Coadministration of ritonavir with sildenafil is expected to substantially increase sildenafil concentrations (11-fold increase in AUC). Use of sildenafil, tadalafil or vardenafil may result in an increase in associated adverse events, including hypotension, syncope, visual changes, and prolonged erection. Use of PDE5 inhibitors for pulmonary arterial hypertension (PAH): Sildenafil (Revatio®) is contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) because a safe and effective dose has not been established when used with ritonavir (see CONTRAINDICATIONS and PRECAUTIONS -- Drug Interactions, Table 5). Use of PDE5 inhibitors for erectile dysfunction: Sildenafil: The starting does should not, in any case, exceed 25 mg in a 48-hour period in patients receiving concomitant ritonavir therapy (see WARNINGS). Tadalafil: Use tadalafil with caution at reduced doses of no more than 10 mg every 72 hours with increased monitoring for adverse events(see WARNINGS). Vardenafil: Use vardenafil with caution at reduced doses of no more than 2.5 mg every 72 hours with increased monitoring for adverse events(see WARNINGS).
Sedative/hypnotics: Parenteral midazolam	↑ midazolam	Co-administration of oral midazolam with NORVIR is CONTRAINDICATED. Concomitant use of parenteral midazolam with NORVIR may increase plasma concentrations of midazolam. Co-administration should be done in a setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered.

The DOSAGE AND ADMINISTRATION section was revised to include the following statement.

Adults
Dose modification for NORVIR
Dose reduction of NORVIR is necessary when used with other protease inhibitors: amprenavir, atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir. Prescribers should consult the full prescribing information and clinical study information of these protease inhibitors if they are co-administered with a reduced dose of ritonavir.

The complete revised labeling will be available at Drugs@FDA.

Norvir is a protease inhibitor, marketed by Abbott Laboratories.

Despite Gains, HIV/AIDS Remains Public-Health Priority, UNAIDS, WHO Say

November 25, 2009

News outlets continued to examine the 2009 AIDS epidemic update released Tuesday by the WHO and UNAIDS:

"The U.N. report said 'AIDS continues to be a major public-health priority' and called for more funds to support efforts to curb the epidemic and to distribute lifesaving drugs," the Wall Street Journal reports. "The U.N. report also suggested that health authorities need to focus resources on those most at risk" (Fairclough, 11/25).

Los Angeles Times: "About 4 million people were receiving AIDS drugs at the end of 2008, compared with 3 million the previous year. Nonetheless, an additional '5 million people need treatment and are not receiving it,' Dr. Teguest Guerma, acting director of the WHO's HIV/AIDS department, said at a Tuesday news conference. She said that about 2.9 million lives had been saved so far by increased access to the drugs as a result of the U.S. President's Emergency Plan for AIDS Relief and other international assistance programs" (Maugh, 11/25).

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VOA News examines the U.S. contributions towards the global fight against HIV/AIDS. The article includes comments by Anthony Fauci, of the National Institute of Allergy and Infectious Diseases, and Michele Moloney-Kitts, assistant coordinator in the office of the global AIDS coordinator. According to Fauci, the National Institutes of Health have "spent about $42 billion from 1982 through fiscal year 2009 on HIV/AIDS research," funding Fauci credited to having helped improve the lives of people living with HIV/AIDS, the news service writes.

"Michele Moloney-Kitts ... said the U.S. government to date has provided about $25 billion, making it the largest donor in the global fight against AIDS, tuberculosis and malaria." The article also includes Moloney-Kitts' comments about the future of PEPFAR under the Obama administration (Butty, 11/24).

"The update cautions that prevention programs often fail to target the populations that are most at risk," Science's "ScienceInsider" blog reports. "Specifically, stigma and local laws prevent many countries from tailoring prevention outreach to highly vulnerable groups like injecting drug users, men who have sex with men, commercial sex workers, and longterm couples in which only one partner is infected. And the sobering bottom line is that five people continue to be infected for every two who start treatment with anti-HIV drugs" (Cohen, 11/24).

Epidemics in Russia, Eastern Europe, China

RIA Novosti examines the findings of the report that "[o]ver 1% of Russian residents are HIV-positive," with the primary route of transmission being injecting drug use. "According to the report, about 37% of Russia's estimated 1.8 million drug users are HIV-infected. Young people account for a considerable number of infections among injecting drug users in the region," the news service writes (11/25).

KyivPost: "'With an adult HIV prevalence of 1.6%, Ukraine has the highest prevalence in all of Europe,' UNAIDS and WHO experts said." The report also found "the estimated number of adults and children living with HIV in Eastern Europe and Central Asia has grown by 66% to 1.5 million since 2001," according to the newspaper (11/25).

The Associated Press examines the report's findings that HIV "is now spreading fastest in China through heterosexual sex, a trend demanding new strategies to stave off a rebound in the epidemic after years of progress in containing it ..." UNAIDS head Michel Sidibe said, "We are seeing a shift in the nature of the epidemic. ... We need to ensure resource allocation is responding to that change."

The article includes details about how "[t]he government remains sensitive about [HIV/AIDS]" and stories of patients living with HIV/AIDS seeking additional support from the government (Kurtenbach, 11/25).

Xinhua/People's Daily Online also reports on the Chinese health minister's response to the UNAIDS report and highlights the efforts of the Chinese government to stop the spread of HIV/AIDS in the country (11/24). In a UNAIDS press release that lauded China's progress on HIV/AIDS Sibide's said, "The world eagerly anticipates China's enhanced role in global governance -- and its leadership in the global response to AIDS" (11/24).