Indian drug maker Cipla on Thursday received tentative FDA approval to produce an oral version of the antiretroviral drug efavirenz, Reuters Health reports (Reuters Health, 5/29). The tentative approval designation means the drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements (Kaiser Daily HIV/AIDS Report, 1/5). In January, former President Clinton announced an agreement reached by the Clinton Foundation that will allow the sale of efavirenz produced by Indian companies Cipla, Ranbaxy Laboratories and Strides Arcolab, as well as South Africa's Aspen Pharmacare, to people in developing countries for no more than $240 per patient annually. In March, Merck announced that it is reducing the price of efavirenz in developing countries by 20% from 95 cents daily to 76 cents daily, making the new annual cost of the drug $277.40 for the 600 milligram formulation (Kaiser Daily HIV/AIDS Report, 3/7).
Monday, September 11, 2006
FDA Grants Cipla Tentative Approval for Oral Version of Antiretroviral Drug Efavirenz
California Could Lose Millions in HIV/AIDS Funding Under Revisions for Ryan White CARE Act Reauthorization
California could lose millions in HIV/AIDS funding under proposed revisions to the Ryan White CARE Act, the Los Angeles Times reports (Lin, Los Angeles Times, 5/29). The Senate Committee on Health, Education, Labor and Pensions earlier this month voted 19-1 to approve a bill (S 2823) that would alter the CARE Act by allocating more federal HIV/AIDS funding to Southern and rural states. The bill would revise the funding calculation formulas to include HIV cases and not just AIDS cases. In addition, the bill, sponsored by HELP Committee Chair Mike Enzi (R-Wyo.) and Sen. Edward Kennedy (D-Mass.), would create a multilevel funding system according to city size in an effort to distribute funds to more rural states. The bill also would mandate 75% of funding go to medical services such as medications and physician visits, and also would set a minimum drug formulary (Kaiser Daily HIV/AIDS Report, 5/18). If the measure becomes law, San Francisco could lose one-fourth of the $28 million in CARE Act funding it receives annually, according to Scott Boule, assistant policy director for the San Francisco Department of Public Health. The Sacramento region could lose all of its $3 million in federal funding, Adrienne Rogers, coordinator of CARE Act programs in the area, said. In addition, federal funding for HIV/AIDS programs in Orange County could decrease from $4.8 million to $1 million within five years, according to Donna Fleming, a disease control manager for the county. "We will not even be able to cover our basic medical care needs," Fleming said, adding, "That's how devastating it is" (AP/San Jose Mercury News, 5/29). Sen. Tom Coburn (R-Okla.) said, "Since we're in a limited budget, the intent is to distribute the money fairly, not disproportionately and unfairly" (Los Angeles Times, 5/29). Coburn in March also introduced a bill (S 2339) that would reauthorize and amend the CARE Act (Kaiser Daily HIV/AIDS Report, 5/17). Michael Montgomery, chief of the Office of AIDS at the California Department of Health Services, said that California's losses might be partly offset by a provision in the bill that would remove a formula that has undercounted the number of AIDS cases in the state by predicting deaths earlier than they occur (Los Angeles Times, 5/29).
In the event of lost funding or other financial hardship, please visit AIDS-DRUGS-ONLINE.com
Alcohol Increases the risk
"Alcohol Use Before Sex and HIV Acquisition: A Longitudinal Study in Rakai, Uganda," AIDS: Iryna Zablotska of the National Centre in HIV Social Research and colleagues examined approximately 6,800 men and more than 8,000 women ages 15 to 49 in Rakai, Uganda, to determine if consuming alcohol before sexual intercourse is linked to an increased risk of HIV transmission. The study -- conducted between 1994 and 2002 -- finds that consuming alcohol prior to sexual intercourse increases the risk of acquiring HIV by 67% for men and by 40% for women. The study also finds that if both partners consume alcohol, the risk increases by 58% for men and by 81% for women (Xinhuanet, 5/31).
GSK to Reduce Price of Some Anitretrovirals Sold in Developing Nations
GlaxoSmithKline on Tuesday announced that it is reducing by about 30% the cost of some of its antiretroviral drugs currently sold at not-for-profit prices in developing countries, Reuters reports. Under the cost reductions, which will take effect on July 1, 60-tablet packs of Trizivir and Ziagen will cost about $70.00 and $52.29, respectively (Reuters, 5/30). The drug company also announced that it will make Kivexa and Telzir available at not-for-profit prices once they have been approved by drug regulatory bodies in developing nations (GSK release, 5/30). GSK plans to differentiate drug shipments intended for not-for-profit markets to ensure they are not diverted back to for profit markets. In addition, the company has signed its eighth voluntary licensing agreement with South Africa-based Sonke Pharmaceuticals, which will allow Sonke to make generic versions of some of its drugs (Reuters, 5/30). In 2003, GSK announced that it was reducing the price of its AIDS drugs by as much as 47% for 63 nations, including all of sub-Saharan Africa. The reduced pricing scheme is available to not-for-profit groups, governments, aid agencies and companies that provide the drugs to their employees (Kaiser Daily HIV/AIDS Report, 4/28/03).
For access to cheap antiretroviral drugs, please visit www.aids-drugs-online.comWednesday, June 21, 2006
Important progress seen in tackling AIDS, but epidemic continues to outpace response, says new comprehensive global AIDS update
New report cites positive trends in HIV prevention and treatment; calls for significant acceleration of the AIDS response
New York, 30 May 2006 – According to new data in the UNAIDS 2006 Report on the global
AIDS epidemic the AIDS epidemic appears to be slowing down globally, but new infections are continuing to increase in certain regions and countries. The report also shows that important progress has been made in country AIDS responses, including increases in funding and access to treatment, and decreases in HIV prevalence among young people in some countries over the past five years.
However AIDS remains an exceptional threat. The response is diverse with some countries doing well on treatment but poorly on HIV prevention efforts and vice-versa. The report indicates that a number of significant challenges remain. Among these are the need for improved planning, sustained leadership and reliable long-term funding for the AIDS response.
-An estimated 38.6 million [33.4 million – 46.0 million] living with HIV worldwide
- 4.1 million [3.4 million – 6.2 million] newly infected in 2005
- 2.8 million [2.4 million to 3.3 million] died of AIDS in 2005
An estimated 38.6 million people are living with HIV worldwide. Approximately 4.1 million people became newly infected with HIV, while approximately 2.8 million people died of AIDS-related illnesses in 2005. While the epidemic’s toll remains massive, experts find reasons for optimism, as well as guidance for how to improve the AIDS response, in today’s report.
“Encouraging results in HIV prevention and treatment indicate a growing return on
investments made in the AIDS response,” said UNAIDS Executive Director Dr. Peter Piot. “We are reaching a critical mass in terms of improvements in funding, political leadership and results on the ground, from which global action against AIDS can and must be greatly accelerated. The actions we take from here are particularly important, as we know with increasing certainty where and how HIV is moving, as well as how to slow the epidemic and reduce its impact.”
The new report is being released in advance of the United Nations General Assembly 2006 High Level Meeting on AIDS, which will bring world leaders to New York from 31 May - 2 June to review progress made since the historic signing of the 2001 Declaration of Commitment, which established concrete, time-bound goals for improving the global AIDS response.
The report cites significant improvements in several elements of the global AIDS response. In the key area of financial resources, the US $8.3 billion available for the AIDS response in 2005 is more than five times the funding available in 2001, and is well within the Declaration of Commitment target range. The report also cites significant increases in global political leadership, which is key to maintaining the AIDS response at the centre of national and international development planning.
Dr. Piot was joined at the report launch by UNICEF Executive Director Ann Veneman, by
United Nations Population Fund (UNFPA) Executive Director Thoraya Obaid representing
the ten cosponsoring agencies of UNAIDS.
The report shows that young people and children are increasingly affected by the epidemic, and efforts to protect these and other vulnerable groups are not keeping pace with the epidemic’s impact.
“For too long, children have often been the missing face of the AIDS pandemic,” said
UNICEF Executive Director Ann Veneman. “It is critical that the impact of HIV/AIDS on
children be addressed through programs to prevent mother to child transmission and to treat cases of paediatric AIDS.”
On HIV prevention, the report documents behaviour changes including delays in first sexual experience, increasing use of condoms by young people, and resulting decreases in HIV prevalence in young people in some sub-Saharan countries.
"Prevention remains our first and most effective line of defence," noted UNFPA Executive Director, Thoraya Ahmed Obaid. "In countries where HIV prevalence is declining among young people, there is behaviour change and comprehensive condom programming. This is encouraging proof that prevention works and saves lives. But women still remain disproportionately vulnerable and greater efforts must be made to give them methods of prevention they can control."
The report also makes clear that on many issues and in most regions of the world greater action against the epidemic is required now, and will be required long into the future. Today’s speakers emphasized that upcoming goals related to universal access to HIV treatment and the 2010 UN goal of halting and beginning to reverse the epidemic will require much greater action moving forward.
KEY FINDINGS
Key findings in the 2006 Report on the global AIDS epidemic include the following:
Funding Resources for the AIDS response have grown from US$1.6 billion in 2001 to US$8.3 billion in 2005, a significant increase that highlights the need to coordinate, monitor and evaluate spending to ensure maximum impact for people in need. In addition to donor funding, domestic public expenditure in heavily impacted countries grew to US$2.5 billion in 2005. At the same time, the report notes that funding gap continues to increase, it is estimated that over US$20 billion will be needed annually as from 2008.
HIV prevention
In an encouraging development, six of 11 African countries reported declines of 25% or more in HIV prevalence among 15-24 year-olds in capital cities. Rates of sex among young people declined in nine of 14 sub-Saharan countries. Condom use with a non-regular partner increased in eight out of 11 countries here, although overall use of condoms remains below 50%. Use of HIV testing and counselling, an important tool for facilitating both treatment and prevention, quadrupled to 16.5 million people tested in 2005. In 58 countries reporting, 74% of primary schools and 81% of secondary schools now provide AIDS education.
While this progress is notable, the HIV prevention response falls short in many areas. The Declaration of Commitment calls for 90% of young people to be knowledgeable about AIDS by 2005, yet surveys indicate that fewer than 50% of young people achieved comprehensive knowledge levels. An area of exceptional concern is the ongoing shortfall in care to prevent mother-to-child HIV infection, in which just 9% of pregnant women are currently covered.
Reducing vulnerability
While some countries, notably Iran, Malaysia and the Kyrgyz Government are adopting more progressive approaches to reducing HIV among injection drug users, overall fewer than 20% of people who inject drugs received HIV prevention services. Coverage is less than 10% in Eastern Europe and Central Asia. Only 10 of 24 countries that reported data for sex workers achieved at least 50% coverage of prevention services for this population. Only 9% of men who have sex with men received any type of HIV prevention service in 2005.
Civil society reports indicate that stigma and discrimination remain pervasive. Half of all reporting countries said that they have laws and policies that interfere with the accessibility and effectiveness of HIV prevention and care. Care and support for the 15 million children orphaned by AIDS, and for millions of other vulnerable children, lag far behind the need.
Treatment
Access to antiretroviral treatment has expanded significantly, from 240,000 people in 2001 to 1.3 million people in low- and middle-income countries in 2005; 21 countries met or exceeded “3 by 5” treatment targets. ARV prices dropped significantly and procurement systems have improved, as has generic drug availability. Still, HIV treatment coverage varies considerably within regions. In sub-Saharan Africa, treatment coverage ranges from 3% in the Central African Republic, to 85% in Botswana.
Leadership
Leadership and political action on AIDS have also increased significantly since 2001. Ninety percent of reporting countries now have a national AIDS strategy; 85% have a single national body to coordinate AIDS efforts; and 50% have a national monitoring and evaluation framework and plan. Yet, systems to implement these plans remain inconsistent, as does civil society involvement and, specifically, involvement of people living with HIV.
“We must move to build upon an increasingly strong foundation by transforming the AIDS response from a year-to-year crisis management approach to one of long-term strategic planning that includes sustained leadership and funding to reduce the epidemic and its impact,” said Dr. Piot.
The 2006 Report on the global AIDS epidemic, prepared by UNAIDS including its
cosponsoring agencies, is the most comprehensive report on the response to AIDS ever
compiled. Utilizing data from 126 countries and more than 30 civil society organizations, the UNAIDS report assessed country progress toward the six global targets set in the UN Declaration of Commitment on HIV/AIDS, adopted by 189 UN Member States in 2001. The 2005 targets are based on the goal of halting and reversing the global epidemic by 2015.
Progress toward those goals was measured against an agreed set of indicators of action developed by UNAIDS in consultation with member states and civil society.
“We are well into an important phase of the global response to AIDS in which deeds and results count more than statements or speeches,” said Dr Piot. “These agreed indicators of progress on AIDS cut through rhetorical responses and put results on display, so they can be reviewed, evaluated, learned from and improved upon.”
Contact
Jonathan Rich | UNAIDS New York | cell. +1 917 650 5697 | jr@jrichconsulting.com
Sophie Barton-Knott | UNAIDS New York | cell. +1 917 379 6948 | bartonknotts@unaids.org
Dominique de Santis | UNAIDS Geneva | tel. +41 22 791 4509 | desantisd@unaids.org
UNAIDS, the Joint United Nations Programme on HIV/AIDS, brings together the efforts and resources of ten UN system organizations to the global AIDS response. Cosponsors include UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, ILO, UNESCO, WHO and the World Bank. Based in Geneva, the UNAIDS secretariat works on the ground in more than 75 countries world wide.
For a copy of the complete report, visit:
http://www.unaids.org/en/HIV_data/2006GlobalReport/press-kit.asp
or
www.aids-drugs-online.com
US Govt Definition of Aids
The Official U.S.
AIDS or HIV (or both)
Just because you have HIV Disease (or are "HIV Positive"), you don't necessarily have the disease called AIDS.
AIDS -- acquired immunodeficiency syndrome -- is a
- It affects how the government handles epidemic statistics.
- It defines who is able to get
Everybody who has AIDS also has HIV Disease. But not everybody with HIV Disease is classified by the
This U.S. Government classification of AIDS has two parts --
1. T-cell count.
2. History of an AIDS-defining disease.
T-cell Count
The term t-cell is the popular name of a cell in the immune system. A better term is CD4 because there are several flavors of t-cells and we need to restrict our discussion to only one kind of t-cell -- officially called "CD4+ T-lymphocytes."
The virus that causes AIDS attacks CD4 cells. The structure of a CD4 cell makes it the easiest target for the virus.
HIV invades your CD4 cells and uses them as a breeding ground for new virus particles. Eventually the CD4 cell is killed by the virus.
As the number of CD4 cells decreases, your risk of getting a severe disease -- or "opportunistic illness" -- increases.
Here are the three official categories of CD4 counts --
| |
| |||||||||||||||
Your disease classification -- asymptomatic, ARC, or AIDS -- is based on the lowest t-cell test you ever had. For example, if you once tested at 180 ... but then got a big boost from a new protease inhibitor ... you are still considered in Category 3.
Your category is the lowest category you have ever been in, not your current category.
There's more to it than CD4 tests. The next section is the official definition.
The Definition Of AIDS
Category 1 (Asymptomatic HIV Disease)
You are in Category 1 only if you are asymptomatic (no symptoms) and have never had less then 500 CD4 cells.
If you have had any of the AIDS-defining diseases listed for categories 2 or 3, then you are not in this category.
If your t-cell count has ever dropped below 500, you are not at Category 1.
Category 2 (ARC)
You are in Category 2 if --
1. your T-cells have dropped below 500 but never below 200; and,
-- or --
2. you have never had any Category 3 diseases (see below) but have had at least one of the following defining illnesses --
o Bacillary angiomatosis
o Candidiasis, oropharyngeal (thrush)
o Candidiasis, vulvovaginal; persistent, frequent, or poorly responsive to therapy
o Cervical dysplasia (moderate or severe)/cervical carcinoma in situ
o Constitutional symptoms, such as fever (38.5 C) or diarrhea lasting greater than 1 month
o Hairy leukoplakia, oral
o Herpes zoster (shingles), involving at least two distinct episodes or more than one dermatome
o Idiopathic thrombocytopenic purpura
o Listeriosis
o Pelvic inflammatory disease, particularly if complicated by tubo-ovarian abscess
o Peripheral neuropathy
According to the
Category 3 (AIDS)
You are in Category 3 (i.e., you have "AIDS") if --
1. your T-cells have dropped below 200;
-- or --
2. you have had at least one of the following defining illnesses --
o Candidiasis of bronchi, trachea, or lungs
o Candidiasis, esophageal
o Cervical cancer, invasive**
o Coccidioidomycosis, disseminated or extrapulmonary
o Cryptococcosis, extrapulmonary
o Cryptosporidiosis, chronic intestinal (greater than 1 month's duration)
o Cytomegalovirus disease (other than liver, spleen, or nodes)
o Cytomegalovirus retinitis (with loss of vision)
o Encephalopathy, HIV-related
o Herpes simplex: chronic ulcer(s) (greater than 1 month's duration); or bronchitis, pneumonitis, or esophagitis
o Histoplasmosis, disseminated or extrapulmonary
o Isosporiasis, chronic intestinal (greater than 1 month's duration)
o Kaposi's sarcoma
o Lymphoma, Burkitt's (or equivalent term)
o Lymphoma, immunoblastic (or equivalent term)
o Lymphoma, primary, of brain
o Mycobacterium avium complex or M. kansasii, disseminated or extrapulmonary
o Mycobacterium tuberculosis, any site (pulmonary** or extrapulmonary)
o Mycobacterium, other species or unidentified species, disseminated or extrapulmonary
o Pneumocystis carinii pneumonia
o Pneumonia, recurrent**
o Progressive multifocal leukoencephalopathy
o Salmonella septicemia, recurrent
o Toxoplasmosis of brain
o Wasting syndrome due to HIV
For information on preventing aids, visit www.aids-drugs-online.com
Tuesday, June 06, 2006
[May 12, 2006]
The HIV/AIDS advocacy groups Delhi Network of Positive People and Indian Network for People Living With HIV/AIDS on Tuesday filed an opposition application with the New Delhi patent office to oppose Gilead's application to patent its antiretroviral drug Viread, known generically as tenofovir, the AP/Houston Chronicle reports (AP/Houston Chronicle, 5/10). India's generic drug industry has made less expensive medications available in India and abroad for more than 30 years. However, India's Parliament last year -- in order to bring the country in line with a World Trade Organization agreement on intellectual property that it signed in 1994 -- changed the country's patent laws to prohibit the domestic production of low-cost, generic versions of patented medicines, including antiretroviral drugs. The measure does not eliminate the supply of existing generic drugs, but it requires generic drug makers that want to continue production to pay royalties to the manufacturers of drugs currently under patent (Kaiser Daily HIV/AIDS Report, 3/24/05). The patent opposition application was filed on behalf of the groups by the Alternative Law Forum (Datta, Hindu Business Line, 5/11). The Indian generic drug company Cipla -- which produces a generic form of tenofovir called tenvir -- also has filed a challenge to Gilead's patent application (MacRae, AFP/Yahoo! News, 5/11). Gilead's tenofovir in Western countries costs $5,718 annually per person, and tenvir costs $700 annually per person in India. Tenvir would be removed from the market for 12 years if Gilead is awarded a patent, the New York Times reports (Gentleman/Kumar, New York Times, 5/12). Cipla Chair Yusuf Hamied said India's new patent law says that drug compounds known before 1995 do not have the "novelty" required for patent protection (AFP/Yahoo! News, 5/11). ALF says that Viread is not a new drug because Gilead added only the salt (fumaric acid) to the existing compound tenofovir, the Times of India reports (Raaj, Times of India, 5/11). The international medical treatment group Medecins Sans Frontieres is providing technical support for the challenge.
Protests, Reaction
Gilead's application prompted a protest by nearly 150 people, some of whom are living with HIV/AIDS, on Wednesday in New Delhi. Police detained and later released 102 of the demonstrators, police officer Parath Singh said (SAPA/Business Day, 5/10). "Granting this patent would set a dangerous precedent," Ellen 't Hoen, director of policy and advocacy for MSF's Campaign for Access to Essential Medicines, said, adding, "Limiting production of tenofovir and that of other newer essential drugs to a single company keeps prices high because generic competition is blocked" (MSF release, 5/10). Gilead in a statement said it disagrees with statements that Viread should not be patented and "believe[s] that Viread represents innovation and is patentable under Indian law." Gilead added that it will "use this patent responsibly" and will not "block access to medication ... in India or in other resource-limited countries where the HIV epidemic has hit the hardest" (Gilead statement, 5/10).
Source: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=37214
Taken from: www.aids-drugs-online.com
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