FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR

The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President’s Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.
The PEPFAR program is a cooperative effort that involves the Food and Drug Administration (FDA) and other HHS agencies, the State Department’s Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many other international partners.
“This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS,” said HHS Secretary Kathleen Sebelius.
To date, more than 100 products that have been assessed by the FDA and either fully or tentatively approved in association with the PEPFAR program. Of these, 29 have been new products and 71 have been generic copies of previously authorized antiretroviral products in the United States. Twenty-two of these new products are new combinations or regimens that have not previously been authorized in the United States. In addition, there are seven new pediatric products considered innovative for patients in developing economies.
“As we recognize the 100th product authorized in this program, it is estimated that FDA’s actions are allowing PEPFAR to spend $150 million more each year on patient access to care,” FDA Commissioner Margaret A. Hamburg, M.D., told those attending an event marking the approval at the Pan American Health Organization (PAHO) headquarters in Washington, D.C. “I look forward to developing and expanding FDA’s international collaborations.”
As of Sept. 30, 2008, the most recent figure available, PEPFAR supported life-saving antiretroviral treatment for more than 2.1 million men, women, and children living with HIV/AIDS. In fiscal year 2008, PEPFAR provided nearly $1.6 billion in support of treatment programs, including antiretroviral drugs and services.
“PEPFAR is committed to supporting partner countries to build and maintain sustainable procurement and supply chain systems,” said U.S. Global AIDS Coordinator Eric Goosby.
Drug products used in PEPFAR receive a “tentative approval” and cannot be approved for marketing in the United States because of existing patents and marketing exclusivity. However, these products meet all the FDA’s manufacturing quality, clinical safety, and efficacy requirements to produce them using the same standards as required for marketing in this country.
FDA performs all of its reviews of applications received in association with the PEPFAR on an expedited basis. After receiving approval or tentative approval from FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows FDA to share data from its evaluations with the WHO team in Geneva.
“Improving access to good quality medicinal products is a core objective of public health efforts and one with a direct and measurable impact on health,” said Margaret Chan, M.D., director-general of WHO.
The goal of PEPFAR is to work with host nations to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, PEPFAR will support training of at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.
“We need to urgently and actively implement strategies to promote greater affordability of both first and second line HIV/AIDS antiretrovirals,” said Mirta Roses, M.D., director of PAHO, an international public health agency that works to improve health and living standards in the Americas. “PEPFAR has made a tremendous difference in the health of disadvantaged people.”
For more information
PEPFAR Web site

AIDS vaccine development , combination of Sanofi-Pasteur's ALVAC canary and HIV vaccine AIDSVAX , Gives promising results for future development

AIDS vaccine resrarch combination of Sanofi-Pasteur's ALVAC canary and HIV vaccine AIDSVAX , Gives promising results for future development .
Results of study conducted in Thiland are very promising and there are lots of  hope become alive after this finding , for HIV vaccine research , as so far no vaccine has so much sucessful in preventing HIV infection , scientists conducted the trials said actual commercial production would be possible in coming five years.


The AIDS vaccine which was studied is a combination of Sanofi-Pasteur's ALVAC canary and HIV vaccine AIDSVAX of San Francisco company called VaxGen and now owned by the nonprofit Global Solutions for Infectious Diseases.
The trial was conducted in group of 16402 Voletiers the risk of infection had been cut by 31.2 per cent
Dr Anthony Fauci of the US National Institute of Allergy and Infectious Diseases, which helped pay for the study. said "Myself, like others, did not think there was a very high chance that this would give any degree of efficacy,"


"But nonetheless, we went ahead with the trial and it was controversial to go ahead with it."


That is the mind of scientist , who will never give up till he finds the solution...Keep it up Sir.

ALVAC is a genetically engineered canarypox virus that has spliced into it synthetic versions of three HIV genes.

AIDSVAX is made using two versions of one HIV gene, one from the B subtype and one from the E subtype.

This is a best logic , and method to combine all possible antigen , which will synergisticaly act to produce maximum protection against incoming infection.

The volunteers participated in this trial were given six immunisations over six months, four with ALVAC and two with AIDSVAX.

(I found all over that peoples have discribed the FAILED vaccine , to discribe AIDSVAX. as it has failed to HIV prevent infection in its individual trial , but i say that was a win for this science , and mankind , we fail and learn where we lacked , and now the combination results are impressive  )   

The results were published on 24-09-09 , this is a big step towards the actual development of an effective vaccine which will provide life saving treatment to this world , against HIV infection in years to come.

Neutralising antibodies, PG9 and PG16 discovered , brings hope for development of HIV vaccine

Today I am writing with proud over my blog that the things that I wrote years before for developing a vaccine for HIV virus are becoming true


(I wrote on this blog on  5-10-2008http://bvwaghmare.blogspot.com/2008/10/hiv-aids-vaccine-development-by-using.html). 

Today on 5-Sep-2009 there was a news coming in from USA , about good results of a research carried out by Sir. Dennis Burton of The Scripps Research Institute in La Jolla, California , who is a imminent immunologist and a great human being too , (without this quality this is impossible to think of providing a life saving treatment to peoples affected by HIV) in the research and development of HIV vaccine.


The development in the research which I am writing about is reported in the journal Science on Friday will help to develop a vaccine against HIV virus , these newly discovered antibodies which attaches themselves to a portion over HIV virus body which do not mutate and they neutralizes the capacity of HIV virus to multiply in number .These antibodies target a stable portion of the HIV virus that does not frequently mutate , These frequent mutations occurring in HIV virus from person to person whom it infect has till now helped the HIV virus escape earlier developed experimental vaccines.


Sir Dennis Burton and fellow scientists have discovered two highly powerful new antibodies that neutralised all major forms of the virus from the body of an African man


Sir Dennis Burton and his team of researchers collected blood samples from more than 1,800 people in Thailand, Australia and Africa who had been infected with HIV for at least three years without the infection proceeding to severe disease.


They have isolated two antibodies, PG9 and PG16, from an African patient. The antibodies were able to block the activity of about three-quarters of the 162 separate strains of HIV they tested it against.


They have also identified the genes in the donor's body responsible for building the neutralizing antibodies.


If this becomes successful we can genetically engineere these antibodies , with the help of this gene, by hybridoma technique , and we can produce these antibodies in vitro, and we can use these antibodies to treat HIV infected peoples.



These antibodies can be used find out which site on the HIV virus is stable and this can be used to develop a protein which will trigger the immune response in event of HIV infection, this logic will help to develop a promising vaccine against HIV virus.


I Congratulat and give my regards to

Sir Dennis Burton and his team and Sir Wayne Koff, senior vice-president of research and development at the International AIDS Vaccine Initiative (IAVI), Scripps Research Institute

For this great work in HIV vaccine development. This finding is going to become a part of treatment for HIV infection in coming days

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