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Changes to the Complera (emtricitabine/rilpivirine/tenofovir dispoproxil fumarate) labeling

2014-07-19T08:45:00.000-07:00

On June 5, 2014, FDA approved changes to the Complera (emtricitabine/rilpivirine/tenofovir dispoproxil fumarate) fixed-dose combination tablet labeling to include rilpivirine dose adjustment information when Complera is coadministered with rifabutin.

If Complera is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant) once per day is recommended to be taken concomitantly with Complera and with a meal for the duration of the rifabutin coadministration.

With these new dosing recommendations, rifabutin was removed from the CONTRAINDICATIONS section.

The revised labeling will be posted soon on the Drugs@FDA web page.

Complera is a product of Gilead Sciences, Inc.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

http://astore.amazon.com/httpwwwkoratv-20

2014-07-06T20:42:00.002-07:00

http://astore.amazon.com/httpwwwkoratv-20

Antiretroviral drugs used in the treatment of HIV infection Drugs Used in the Treatment of HIV Infection Click on drug brand name for additional information.

2014-07-06T20:02:00.000-07:00

ATRIPLA

2014-07-06T07:50:00.001-07:00

ADDITIONAL IMPORTANT SAFETY INFORMATION for
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)

Who should not take ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?

You and your healthcare provider should decide if ATRIPLA is right for you. Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients.

What should I tell my healthcare provider before taking
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?

Tell your healthcare provider if you:

Are pregnant or planning to become pregnant: Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control, while on ATRIPLA and for 12 weeks after stopping ATRIPLA. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective.
Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV and some of the medicines in ATRIPLA through their milk to the baby. We do not know if ATRIPLA could harm your baby.
Have kidney problems or are undergoing kidney dialysis treatment
Have bone problems
Have liver problems, including hepatitis B or C virus infection. Your healthcare provider may want to do tests to check your liver while you take ATRIPLA or may switch you to another medicine.
Have ever had mental illness or are using drugs or alcohol
Have ever had seizures or are taking medicine for seizures. Seizures have occurred in patients taking efavirenz, a component of ATRIPLA, generally in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you.

What important information should I know about taking other medicines with
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?

ATRIPLA may change the effect of other medicines, including the ones for HIV-1, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses.

MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA

Do not take ATRIPLA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Vascor^® (bepridil), Propulsid^® (cisapride),Versed^® (midazolam), Orap^® (pimozide), Halcion^® (triazolam), or ergot medications (for example, Wigraine^® and Cafergot^®).
ATRIPLA should not be taken with: Combivir^® (lamivudine/zidovudine),
COMPLERA^® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate),
EMTRIVA^® (emtricitabine), Epivir^® or Epivir-HBV^® (lamivudine),
Epzicom^® (abacavir sulfate/lamivudine),
STRIBILD^® (elvitegravir/cobicistat/emtricitabine/tenofovir DF),
Trizivir^® (abacavir sulfate/lamivudine/zidovudine),
TRUVADA^® (emtricitabine/tenofovir DF), or VIREAD^® (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. ATRIPLA should not be used with
SUSTIVA^® (efavirenz) unless recommended by your healthcare provider.
Vfend^® (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA.
Do not take St. John’s wort (Hypericum perforatum), or products containing St. John’s wort with ATRIPLA. Taking St. John’s wort may decrease ATRIPLA levels and lead to increased viral load, and possible resistance to ATRIPLA or cross-resistance to other anti-HIV-1 drugs.
ATRIPLA should not be used with HEPSERA^® (adefovir dipivoxil).

These are not all the medicines that may cause problems if you take ATRIPLA. Tell your healthcare provider about all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.

What are the possible side effects of
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?

ATRIPLA may cause the following additional serious side effects:

Serious psychiatric problems. Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide, and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.
Kidney problems (including decline or failure of kidney function). If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider should do regular blood tests. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness.
Other serious liver problems. Some patients have experienced serious liver problems, including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
Changes in bone mineral density (thinning bones). Lab tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia), which could lead to fractures. Also, bone pain and softening of the bone (which may lead to fractures) may occur as a consequence of kidney problems. If you have had bone problems in the past, your healthcare provider may want to do tests to check your bones or may prescribe medicines to help your bones. Also, bone pain and bone softening may occur because of kidney problems.

Common side effects:

Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with ATRIPLA. These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach; they tend to go away after taking ATRIPLA for a few weeks. Tell your healthcare provider right away if any of these side effects continue or if they bother you. These symptoms may be more severe if ATRIPLA is used with alcohol and/ormood-altering (street) drugs.
If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
Rash is a common side effect with ATRIPLA that usually goes away without any change in treatment. Rash may be serious in a small number of patients. Rash occurs more commonly in children and may be a serious problem. If a rash develops, call your healthcare provider right away.
Other common side effects include: tiredness, upset stomach, vomiting, gas, and diarrhea.

Other possible side effects:

Changes in body fat have been seen in some people taking anti-HIV-1 medicines. Increase of fat in the upper back and neck, breasts, and around the trunk may happen. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these changes in body fat are not known.
Skin discoloration (small spots or freckles) may also happen.
In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. If you notice any symptoms of infection, contact your healthcare provider right away.
Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness, and indigestion.

This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate).

You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome.

Please see Full Prescribing Information, including “What is the most important information I should know about ATRIPLA” in the Patient Information section.

2013-09-22T09:34:00.002-07:00

A new drug to treat HIV infection was approved by the U.S. Food and Drug Administration on Monday.

Marketed as Tivicay, the medication interferes with an enzyme that is essential to the ability of the HIV virus to multiply and spread within the human body, the agency said in a news release. It is a pill that is to be taken once a day with other HIV drugs, according to the FDA.

"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the release. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."

Approved for use in both people who have been diagnosed with HIV but have never taken medications to treat the virus and in those who have taken other HIV drugs, Tivicay (dolutegravir) is also approved for certain children under the age of 12.

The approval was based on the results of five clinical trials involving more than 2,500 patients. Insomnia and headaches were common side effects of the medication, along with hypersensitivity and abnormal liver function in HIV patients who have also been diagnosed with hepatitis B and/or C, the agency said in the release.

Almost 50,000 Americans are infected with HIV every year, according to the U.S. Centers for Disease Control and Prevention, and more than 15,000 died of the disease in 2010.

Tivicay is made by GlaxoSmithKline, based in Research Triangle Park, N.C., according to the FDA.

WHO RISK ASSESSMENT Human infections with influenza A(H7N9) virus 13April 2013

2013-05-17T23:29:00.000-07:00

WHO RISK ASSESSMENT

Human infections with influenza A(H7N9) virus

13April 2013

Summary of available information
As of 13April 2013, a total of 49 confirmed cases of human infection with avian influenza A(H7N9)
virus have been reported to WHO by the China National Health and Family Planning Commission.
Among these cases, the ages range from 4 to 87; 15 are female. Eleven persons have died, and the
majority of the additional cases are considered severe. Of the 49 cases, 6 have been reported today
and further investigations are taking place. The cases have been reported from three provinces:
Anhui, Jiangsu and Zhejiang, and two municipalities, Beijing and Shanghai. All locations are in Eastern
and Northern China.
Two confirmed cases have been associated with possible family clusters, in which one and two
additional family members,respectively, developed severe pneumonia. Close contacts of confirmed
cases and health care workers caring for cases have been monitored for infection. So far, among the
contacts who have been tested by polymerase chain reaction, none has been shown to have
infection.
This is the first time human infection with this influenza subtype, avian influenza A(H7N9) virus, has
been detected. Previously,sporadic cases of human infection with otherinfluenza A(H7) viruses
have been reported. Those cases were associated with outbreaks of infection in poultry in other
countries. These earlierinfluenza A(H7) human infections generally resulted in mild influenza illness
with some conjunctivitis.
Genetic and laboratory characterization of the first three of these H7N9 virusesisolated from
humans indicatesthat:

• the virus contains a group of avian influenza virus genes from three different avian influenza
viruses;
• to date, genetic analyses of the isolates have shown certain changes, including amino acid
substitutions associated with increased affinity to alpha 2-6 receptors, which suggests that
the H7N9 virus may have greater ability to infect mammalian species, including humans,
than most other avian influenza viruses;
• there are sequence variations among the genes of three isolates that suggestthere has been
more than one introduction of this virus from animal into humans;
• these viruses are expected to be sensitive to the neuraminidase inhibitor drugs oseltamivir
and zanamivir, but resistant to the antiviral drugs amantadine and rimantadine;
• the isolates have a haemagglutinin structure thatis associated with low pathogenicity in
birds.
There are several gaps in critical information at this time, including the animal reservoir(s)in which
this virus is circulating, the main exposures and routes of transmission for how human infections
have been acquired, and the current scope of the spread of this virus among animal and human
populations. Avian influenza A(H7N9) viruses have now been isolated from poultry (including duck)
and pigeon in the live birdmarketsin some areas of China, but whether other potential reservoirs of

this virus may exist, including in other domestic and wild bird species, and mammalian species such
as pigs, has not yet been determined clearly.
So far, this virus has not been associated with reports of severe disease in poultry.
Risk assessment
This initial risk assessment, which has been prepared in accordance withWHO’s published
recommendations for rapid risk assessment of acute public health events1
will be updated as further
information becomes available.
What is the risk of the occurrence of further cases in the affected areas of China and other areas?
The epidemiology of this virus among animals, including the main reservoirs of infection among
animals and the extent of geographic spread, is not yet established. However, it is likely that most
human H7N9 infections so far are associated with infection among as-of-yet undetermined animals
and that further human cases of infection should be expected.
What is the risk of human-to-human transmission?

There is no evidence of sustained human-to-human transmission. However the two possible family
clusters suggestthat limited human-to-human transmissionmay occur where there is close contact
between cases and other individuals, as occurs in families and, potentially, healthcare settings.
Moreover, the genetic changes seen among these viruses suggesting adaptation to mammals is of
concern, and further adaptation may occur.
What isthe risk of international spread?
At this time, there is no information to indicate international spread of this virus. However, it is
possible that an infected person, who may or may not have symptoms, could travel to another
country. However, if the virus cannot sustain human-to-human transmission, as appears to be the
current situation, then extensive community spread is unlikely.
WHO does not advise special screening at points of entry with regard to this event, nor does it
recommend that any travel or trade restrictions be applied.

References
Most recent disease outbreak news can be found at:
http://www.who.int/csr/don/en/index.html
Background and summary of human infection with influenza A(H7N9) virus (as of 5 April 2013):
http://www.who.int/influenza/human_animal_interface/update_20130405/en/index.html
Frequently Asked Questions on human infection with influenza A(H7N9) virus, China:
http://www.who.int/influenza/human_animal_interface/faq_H7N9/en/index.html

Human infection with a new type of influenza virus A(H7N9)

2013-05-17T23:14:00.000-07:00

The World Health Organization (WHO) has been officially notified by the China National Health and Family Planning Commission about human infection (and deaths) with an influenza virus subtype A(H7N9) that has not been previously reported in humans. There is no indication of human-to-human transmission associated with these patients. WHO is working closely with it's Collaborating Centres for influenza to discuss and strengthen diagnostics and case management. At present, the reservoir, source of infection and mode of transmission remain unknown.

Yellow fever vaccination booster not needed

2013-05-17T23:06:00.001-07:00

17 MAY 2013 | GENEVA - The yellow fever ‘booster’ vaccination given ten years after the initial vaccination is not necessary, according to WHO. An article published in WHO’s Weekly Epidemiological Record (WER) reveals that the Organization’s Strategic Advisory Group of Experts on immunization (SAGE) has reviewed the latest evidence and concluded that a single dose of vaccination is sufficient to confer life-long immunity against yellow fever disease.

Since yellow fever vaccination began in the 1930s, only 12 known cases of yellow fever post-vaccination have been identified, after 600 million doses have been dispensed. Evidence showed that among this small number of “vaccine failures”, all cases developed the disease within five years of vaccination. This demonstrates that immunity does not decrease with time.

Important news for yellow fever endemic countries and travellers

“The conventional guidance has been that the yellow fever vaccination has had to be boosted after ten years,” says Dr Helen Rees, chair of SAGE. “Looking at really very good evidence, it was quite clear to SAGE that in fact a single dose of yellow fever vaccine is effective. This is extremely important for countries where yellow fever is endemic, because it will allow them to reconsider their vaccine scheduling. It is also important for travelers.”

Yellow fever is an acute viral haemorrhagic disease transmitted by infected mosquitoes that is endemic to 44 countries in tropical areas of Africa and the Americas. Infection with the yellow fever virus causes varying degrees of disease, from mild symptoms to severe illness with bleeding and jaundice and fatal outcomes.

Estimated 200 000 new cases each year

There are an estimated 200 000 cases of yellow fever worldwide each year. About 15% of people infected with yellow fever progress to a severe form of the illness, and up to half of those will die, as there is no cure for yellow fever. The treatment is aimed simply at reducing patients’ discomfort.

The vast majority of reported cases and deaths occur in sub-Saharan Africa. In endemic regions of Africa, yellow fever natural immunity is acquired with age, putting children at highest risk of infection. Over the past two decades, the number of yellow fever cases worldwide has increased due to declining population immunity to infection, deforestation, urbanization, population movements and climate change.

Vaccination is the most effective measure

Vaccination is considered to be the most important and effective measure against yellow fever. Protective immunity develops within 30 days for 99% of people receiving the vaccination. For routine immunization programmes in Africa, home to 31 of the 44 yellow-fever endemic countries, the vaccine costs about $0.82 per dose.

SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions. SAGE is concerned with all vaccine-preventable diseases including childhood vaccines and immunization.

For more information please contact:

Fadéla Chaib
Communications Officer/Spokesperson
Telephone: +41 22 791 32 28
Mobile: +41 79 475 55 56
E-mail: chaibf@who.int

Human infection with avian influenza A(H7N9) virus

2013-05-17T23:01:00.002-07:00

17 MAY 2013 - Since 8 May 2013, no new laboratory-confirmed cases of human infection with avian influenza A(H7N9) have been reported to WHO by the National Health and Family Planning Commission, China. However, four additional deaths have been reported from previously laboratory-confirmed cases.

To date, WHO has been informed of a total of 131 laboratory-confirmed cases, including 36 deaths.

Authorities in affected locations continue to maintain enhanced surveillance, epidemiological investigations, close contact tracing, clinical management, laboratory testing and sharing of samples as well as prevention and control measures. In the past week, the Shanghai and Zhejiang provincial governments have started to normalize their emergency operations into their routine surveillance and response activities. WHO offices in country, regional and headquarters continue to work closely to ensure timely information updates.

Until the source of infection has been identified and controlled, it is expected that there will be further cases of human infection with the virus.

So far, there is no evidence of sustained human-to-human transmission.

WHO does not advise special screening at points of entry with regard to this event, nor does it currently recommend any travel or trade restrictions.

WHO continues to work with Member States and international partners. WHO will provide updates as the situation evolves.

Researching HIV in WikiLeaks Cables

2012-07-31T07:38:00.001-07:00

All 251,287 WikiLeaks "Cablegate" cables have now been released (apparently by opponents of Assange). They are searchable, and 'HIV' is mentioned in 1534 of them. While 107 cables are tagged 'HIV', many other relevant cables are not.

Several specialized search engines will search this huge archive for whatever you want. We used www.CableDrum.net for this article. (Apparently the full text of the cables is indexed in Google, though not in Bing.)

To try CableDrum yourself, visit the site and type HIV into the "Search text" box, then click the Search button. A search might take half a minute or so, but then you should see the Subject of the first 25 of the 1534 cables containing 'HIV'. To read the full text of the cable, click the "Reference ID" on the left of the Subject line.

For this article we decided to look at two issues:

What was the U.S. reaction as it became clear that Australia was doing much better than the U.S. in AIDS prevention -- apparently due mainly to very different policies on needle exchange?
How did the U.S. embassies see PEPFAR (President's Emergency Fund for AIDS Relief), the outstandingly successful U.S. program to make AIDS treatment available on a large scale to poor countries that otherwise had very little access?

Our research is incomplete, and presented mainly to show you how to use the cable database.

AUSTRALIA AND NEEDLE EXCHANGE

"[Needle exchange programs] have played a vital role in helping prevent the spread of blood-borne illnesses in Australia, according to Paul Dessaur of WASUA. 'In Australia, for instance, the rate of HIV amongst injecting drug users is less than 1 percent, and that is unheard of, and it's purely because we introduced these programs way back in 1986,' he said." [2012,www.cdcnpin.org/scripts/display/NewsDisplay.asp?NewsNbr=59528]

We don't have a comparable U.S. figure for the infection rate among IDUs, but it is probably well over 10 times higher.

Our search for HIV and Australia as tags found nothing. A search for:
HIV Australia
in the full text found 79 cables. Most of them were unrelated, so we tried:
Australia hiv "syringe exchange"
with no result. But:
Australia hiv "needle exchange"
found one result, www.cabledrum.net/cables/09MOSCOW3072, which is relevant (one of only two we've found so far). It described Russia's chief medical officer as "positive about needle exchange
programs, saying that they were proving effective."

Searching for
Australia "needle exchange"
(no need to mention HIV) found 7 results, including the above, plus another relevant cable (www.cabledrum.net/cables/09UNVIEVIENNA64), also dated 2009, referred to the "new USG [United States Government] position: support for needle exchange programs as a method to prevent the spread of HIV/AIDS, and for medication-assisted therapy as part of a comprehensive treatment protocol against narcotic addiction, and continued USG opposition to the term 'harm reduction'."

What we have not yet done is to read through all the cables mentioning just "needle exchange", "syringe exchange", or with a tag HIV (about 150 cables in all), to find anything that may be relevant.

But already it seems fairly clear already that there is no acknowledgement or discussion of Australia's success with needle exchange anywhere in the text of the 251,287 cables obtained by WikiLeaks. Any such cable would almost certainly include the word 'Australia', and either 'needle exchange' or 'syringe exchange', and we checked all of those cables.

PEPFAR SUCCESS

Our work on this search is less complete. Much more remains to be done.

There is no tag for 'PEPFAR' (which seems odd), but the word appears in 587 of the cables. The next step might be to read all places where 'PEPFAR' appears in these cables, to see what is interesting. This would exclude the cable about checking whether the 20 telephones in a new PEPFAR office were working correctly -- and those with only general statement of good intentions, such as:
"USG-Nigeria PEPFAR team submitted the 2010 annual Country Operation Plan (COP) to the Global AIDS Coordinator January 29. The plan builds a partnership for sustainability with the Nigerian Government to continue strengthening ongoing service delivery to patients; renew focus on health systems strengthening; and align activities with the Nigerian National Strategic Framework for HIV-AIDS, 2010-2015. The Plan will also intensify and focus prevention efforts; deepen integration of HIV-AIDS response into the broader health care system; strengthen the health care system at all levels; and expand access to quality services. USAID's proposed FY2010 PEPFAR budget is 249.9 million dollars."

THE SURPRISE

What most surprised us is the lack of perspective in the diplomatic world -- how little attention and actual thinking concern HIV, an epidemic that has killed tens of millions of people including half a million in the U.S. Vastly more attention goes into the drug war -- a shooting war which, in its current form, started a century ago in the U.S., and has been a continuous failure ever since. It still has no victory in sight, only more of the same. The basic flaw may be the same as in other U.S. shooting wars -- the lack of any sane or real mission, since the actual purpose of the war is to create financial opportunities for corporations, contractors, careerists, and other well-placed special interests.

A fundamental problem is that perspective and thinking are dangerous in diplomatic (and other government or corporate) careers; those who think may not last. In theory the thinking will be done at higher levels, but the system is too corrupt for that. So major institutions proceed like zombies, decade after decade and century after century, with results that we see every day.

AIDS2012 Conference, July 22-27 -- Washington DC or Anywhere

2012-07-31T07:32:00.001-07:00

AIDS2012, the XIX International AIDS Conference, happens this month, July 22-27, 2012, at the Washington Convention Center in Washington, DC. More than 20,000 people are expected to attend. AIDS2012, organized by the International AIDS Society (iasociety.org) and many others, is the largest AIDS gathering in the world. It takes place in different countries, every two years.

Below are some online information sources that can help you follow the conference news, whether you are at the meeting or not.

[Note: in case you happen to be in the Washington area but not attending the conference officially, one part of the conference, the Global Village, is free and open to the public this year. About 250 AIDS-related organizations from around the world will be presenting there, so you can probably find people you want to meet. While there are likely to be scheduled presentations within the global village, it is mainly a place for informal discussions. (See below for how to participate in these and other discussions even if you are far from Washington.)]

All the sites in this article are publicly accessible (although parts of the official site can only be visited by persons attending the conference, who log in with their conference credentials).

Of the hundreds of sites that will report news from the conference and would be worth listing here, we picked just a handful that are most important for our readers to know about.

OFFICIAL CONFERENCE SITE: WWW.AIDS2012.ORG

When looking at all the dozens of items and links available on the home page, don't overlook the navigation bar at the top, with links to the official conference blog, and to the Global Village (plus the youth program, and the media center).

The U.S. government's AIDS blog, blog.aids.gov/, has an entry listing the official partners of the IAS for this conference. For the full list, see http://blog.aids.gov/2012/06/how-to-stay-updated-during-aids-2012.html. Some of the partner organizations:
* The Kaiser Family Foundation will provide official coverage of the conference, including video of some of the major sessions, and daily news reports. For more information see www.kff.org/hivaids/hiv062712nr.cfm.
* For basic science news reporting, Science magazine (sciencemag.org) is a good place to start, especially Jon Cohen's articles on AIDS.
[But like too many science and medicine journals, some of the articles are for sale for prohibitive individual prices (at profit margins we estimate at 100,000% or greater, compared to the cost of online delivery -- note that the journals seldom pay for any of the research being reported). To see the full text, you need to be rich or be part of an institution such as a university. Usually anyone can see at least an abstract or summary of research article, and sometimes the full text is made free as well. And some some material is free, but only to registered users (registration is free).]
* The same is true for the Lancet, a medical journal that is also one of the official partners. The Lancet published a number of AIDS articles shortly in advance of the conference, at www.thelancet.com/journals/lancet/issue/vol379no9835/PIIS0140-6736%2812%29X6026-4. Publishing in advance is helpful, since interested persons can read the new information ahead of time and use it to inform many discussions at the meeting.
* POZ/Aidsmeds (http://poz.com/), and Aidsmap (www.aidsmap.com/), are two other conference partners with excellent news coverage on AIDS, written for persons with AIDS and the interested public. Check their conference coverage before, during, and after AIDS2012.
* For religious information, check the Interfaith pre-conference meeting,blog.aids2012.org/post/Interfaith-pre-conference-%E2%80%9CTaking-Action-for-Health-Dignity-and-Justice%E2%80%9D.aspx (This page was hard to find from the main aids2012.org page, which may explain why there were no comments as of early July.)

SATELLITE SESSIONS

For officially recognized satellite sessions (both non-commercial, and commercial) see:
aids2012.org/WebContent/File/AIDS2012_Satellites_List.pdf
Sometimes the public can go to these; sometimes a conference badge is required.

NON-OFFICIAL SITES (NOT OFFICIALLY CONNECTED WITH THE CONFERENCE)

Of hundreds of news and other sites, we note three:
AIDS2012 Reunion, www.aids2012reunion.org/ A new organization, focused entirely on this conference for now.
Project Inform, www.projectinform.org/. One of the first AIDS treatment information organizations, still doing excellent AIDS treatment news coverage.
NATAP (National AIDS Treatment Advocacy Project), www.natap.org/, especially for important technical/scientific information.

For more conference coverage, you can do a Google search such as:
"aids conference" 2012
This search finds about 2,000,000 pages on this and other conferences -- fortunately listed by Web popularity. The official aids2012.org pages are organized at the top of the search results, quickly followed many non-official websites and page -- so you don't need to scroll through hundreds of official pages first.

USING TWITTER TO FIND CONFERENCE COVERAGE

You don't need a Twitter account. Just go to search.twitter.com and search for whatever interests you. Twitter shows what's going on now, not going far back into the past. Note: Twitter's search will probably show you the "Top" tweets, but let you choose "All" -- which you probably do want to choose. Also note that Google no longer works for finding tweets; Twitter unfortunately revoked Google's access a year ago, to improve its own search instead.

You can search for #aids2012 (best to include the hash mark). This "hash tag" was suggested by the conference, to use in the text of tweets (Twitter messages) in order to bring them to the attention of people searching for information about the conference. But anyone with a Twitter account can use this hash tag in their tweets -- so be aware that spam or misinformation could also be sent this way.

The Global Village is tweeting officially from @gvaids2012 (no one else can send FROM that Twitter address). We haven't seen anyone using the similar hash tag #gvaids2012 as of early July (note the hash mark punctuation instead of the at-sign), but we recommend it and think people will be using it during the conference and a little before. Anyone with a Twitter account can send a tweet from their phone or computer with this hash tag in it, immediately and without waiting for anyone's approval -- a good way to share news instantly within or about the Global Village (as well as with the rest of the world). And if the people running the official @gvaids2012 account like some of these messages, they can re-tweet them to all followers of @gvaids2012 (whether or not those followers ever search for the hash tag). So using a name in this way (with the'@' from the owner of the Twitter account exclusively, and the '#' for the hash tag that anyone can use) gives both an official and an unofficial channel on the subject (the Global Village of AIDS2012, in this case).

Note that anyone in the world can discuss the AIDS2012 conference on Twitter -- no need to be in Washington. (Well, not anyone; some countries ban Twitter.) You do not need a Twitter account nor any prior knowledge to search recent tweets at search.twitter.com, e.g. for #aids2012, or for the Global Village. You do need a Twitter account to send your own tweets, and also to follow others' Twitter accounts (meaning to receive all the tweets they send).

Each tweet can only have 140 characters -- basically a short sentence. But about a dozen of the 140 can optionally be used for a Web link, so the tweet can tell you about something quickly, and let you click for more information if you want. As of July 11, 2012,m a new tweet is being sent about every two minutes during the workday Washington time, usually pointing you to more information on the Web, and also at the conference.

A major advantage of Twitter is that you can look things up by searching (either for a hash tag, or just for a word in the tweet), and then connect with people who share a mutual interest, whom you might never otherwise have met.

CONFERENCES OF THE FUTURE

The bottom line is that you can virtually attend AIDS2012, and have input, even if you are thousands of miles from Washington. We believe that conferences will and should continue to evolve in this direction. Eventually the lectures presenting scientific, medical, and other information will be largely online, with important results released any time they are ready, not held up for arbitrary conference or publication dates. Online (or DVD) presentations are better educationally than lectures in auditoriums, since everyone can see the slides and hear the speakers, can rewind if necessary, and can consult outside materials easily. Why should scientific and medical research reports be tied to the great expense of air travel, hotels, and conference admission?

Future physical meetings will be for persons who need to meet face-to-face with particular working groups and individuals. Based on past experience of online communication actually increasing physical meetings, these better-focused conferences could be even larger than the ones today. For those who can travel abroad it will be better to make one international trip to take care of most of one's global meeting needs, than to make separate trips. And for those who cannot travel, online and DVD information will be much better than it is today -- and more important than the physical meetings that are hundreds of times more expensive.

2012-06-17T23:33:00.004-07:00

Emtricitabine/tenofovir/efavirenz

Emtricitabine/tenofovir/efavirenz (INNs, trade name Atripla) is a fixed-dose combination drug for the treatment of HIV infection. It combines Gilead Sciences's tenofovir and emtricitabine (already available in the anti-HIV combination Truvada) with Bristol-Myers Squibb's efavirenz into a fixed-dose pill. Combining the three drugs into a single, once-daily pill reduces pill burden and simplifies dosing schedules, and therefore has the potential to increase adherence to antiretroviral therapy.

Atripla is the first multi-class antiretroviral drug available in the United States and represents the first collaboration between two U.S. pharmaceutical companies to combine their patented anti-HIV drugs into one product.^[1] The drug retails in the United States for US$1,850 for a one-month supply. As of 2007, annual cost in India is US$1,344, and US$528 in Africa. It was approved by the U.S. FDA on July 12, 2006. In the UK, the drug cost to the NHS is GB£626.90 per month^[2] as of March 2012.

Atripla is a fixed dose combination of 600 mg efavirenz, 245 mg tenofovir, and 200 mg emtricitabine. In adults, it is taken once daily on an empty stomach. Dosing at bedtime is recommended to improve tolerability of nervous system symptoms. Atripla is not recommended for patients under 18 years of age.

Atripla is a pink, film-coated tablet with "123" impressed on one side.

In North America and Europe, Atripla is marketed jointly by Gilead Sciences and Bristol-Myers Squibb, but in much of the developing world, marketing and distribution is handled by Merck & Co.^[3] Cipla released its own version of Atripla in India, called Viraday. In Argentina, Atripla is marketed by Laboratorios Gador.

WHO: HIV drug resistance is present but can be managed

2011-09-29T23:34:00.001-07:00

18 JULY 2012 | GENEVA / WASHINGTON DC - Increased use of HIV treatment known as antiretrovirals (ARVs) in low- and middle-income countries has resulted in resistance to some forms of treatment, but not to the extent seen when HIV medication was first introduced in high-income countries in the 1990s, according to a new report from WHO.

Some eight million people are now taking ARVs in low- and middle-income countries – up from 400 000 in 2003. By 2010, the amount of HIV that was resistant to ARVs among people initiating treatment in the areas surveyed for the report, stood at 6.8%. Over a similar period of time after introducing ARVs in high income countries, slightly higher rates of drug resistance – between 8-14%, depending on the region – were being reported.

Good programme management and antiretrovirals

A number of factors have helped keep down levels of drug resistance in low- and middle-income countries. These include good programme management and the use of simpler, more effective combinations of antiretrovirals than those originally introduced in high-income countries in the 1990s.

“Simpler regimens using fixed-dose combinations have made it much easier for people to adhere to antiretroviral treatment, limiting the spread of drug resistance in recent years. This is good news for public health,” says Dr Gottfried Hirnschall, Director of WHO’s HIV department. “Our task now is to ensure that drug resistance remains limited and manageable.”

Preventable factors

Some degree of HIV drug resistance is generally expected to occur due to natural mutations in the virus; but most cases of drug resistance are caused by preventable factors such as treatment interruptions and patients taking medicines incorrectly.

“We need to make sure that people get the right medicines and that they stick to their treatment. This includes making sure that the drugs are easy to take, the supply is reliable, and that patients are followed closely to identify cases of treatment failure at an early stage,” says Dr Joseph Perrïens, of WHO’s HIV Department.

Loss of contact poses serious threat

Surveys in 12 low- and middle-income countries show that many health facilities currently lose contact with significant proportions (up to 38%) of people who start taking antiretrovirals. Loss of contact poses a serious threat to the control of drug resistance as most of these people interrupt or completely stop treatment. This not only means that they are themselves more likely to become sick, it also increases the likelihood that drug resistance will emerge and the resistant virus could be transmitted to others.

The surveys also highlight the need for stronger tracing and routine surveillance of HIV drug resistance in low- and middle-income countries to alert programme planners to patterns of drug resistance.

WHO recommendations

WHO recommends that every clinic providing antiretroviral treatment should use a set of ‘early warning indicators’ to identify and address factors that could cause drug resistance. Indicators include:

adherence to treatment
the type of medicines used
continuity of drug supply
the extent to which patients continue to access services.

At sites where patients can routinely have the amount of virus in their blood tested, WHO also recommends monitoring how well the medicine is suppressing a patient’s amount of HIV at 12 months to identify treatment failure at an early stage. A rise in the amount of virus a patient has in their blood is an indicator that the current treatment is failing.

Global network of surveillance laboratories and collaborating institutions

To support these recommendations, WHO has created a global network of surveillance laboratories and collaborating institutions to monitor HIV drug resistance and to exchange information with HIV programmes and technical partners. The Organization is also working to improve the laboratory capacity in countries to improve their ability to study the genetic makeup of the viruses and whether they are resistant to medicines. Understanding genetic patterns of drug resistance helps health care workers provide more effective, longer-lasting treatment options to patients.

For more information and to arrange interviews, contact:

Sarah Russell (Washington DC)
Mobile: +41 79 598 6823
E-mail: russellsa@who.int

Glenn Thomas (Geneva)
Telephone: +41 22 791 3983
Mobile: +41 79 509 0677
E-mail: thomasg@who.int

บ้านโคราช

Changes to the Complera (emtricitabine/rilpivirine/tenofovir dispoproxil fumarate) labeling

http://astore.amazon.com/httpwwwkoratv-20

Antiretroviral drugs used in the treatment of HIV infection Drugs Used in the Treatment of HIV Infection Click on drug brand name for additional information.

ATRIPLA

ADDITIONAL IMPORTANT SAFETY INFORMATION forATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)

WHO RISK ASSESSMENT Human infections with influenza A(H7N9) virus 13April 2013

Human infection with a new type of influenza virus A(H7N9)

Yellow fever vaccination booster not needed

Important news for yellow fever endemic countries and travellers

Estimated 200 000 new cases each year

Vaccination is the most effective measure

For more information please contact:

Human infection with avian influenza A(H7N9) virus

Researching HIV in WikiLeaks Cables

AUSTRALIA AND NEEDLE EXCHANGE

PEPFAR SUCCESS

THE SURPRISE

AIDS2012 Conference, July 22-27 -- Washington DC or Anywhere

OFFICIAL CONFERENCE SITE: WWW.AIDS2012.ORG

SATELLITE SESSIONS

NON-OFFICIAL SITES (NOT OFFICIALLY CONNECTED WITH THE CONFERENCE)

USING TWITTER TO FIND CONFERENCE COVERAGE

CONFERENCES OF THE FUTURE

Emtricitabine/tenofovir/efavirenz

WHO: HIV drug resistance is present but can be managed

Good programme management and antiretrovirals

Preventable factors

Loss of contact poses serious threat

WHO recommendations

Global network of surveillance laboratories and collaborating institutions

For more information and to arrange interviews, contact:

ADDITIONAL IMPORTANT SAFETY INFORMATION for
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)