Women More Susceptible to HIV/AIDS than Originally Thought

A new study has found that HIV appears to attack normal, healthy genital tissue in women and does not require breaks in the skin to infiltrate cells, offering new perspectives on how the virus is spread, researchers said on Tuesday, Reuters reports. Thomas Hope, a study author from Northwestern University's Feinberg School of Medicine, said that scientists have had little detailed understanding of how HIV is transmitted sexually in women and that it was "previously thought there had to be a break in [genital tissue] somehow" for women to contract the virus. He added that the study's findings show that "[n]ormal skin is vulnerable."

For the study, researchers in a partnership between Northwestern and Tulane University introduced HIV -- which carried fluorescent, light-activated tracers, a new method developed to better see how the virus worked -- to newly removed vaginal tissue taken from hysterectomy surgeries. A microscope was used to observe the virus as it penetrated the outer lining of the female genital tract -- also called the squamous epithelium -- and found that HIV was able to move quickly past the skin barrier to reach immune cells. The process also was observed in nonhuman primates, according to Reuters. In addition, the results of the study suggest that HIV focuses on areas of the genital tissue where skin cells recently had been shed, Hope said (Steenhuysen, Reuters, 12/16). Hope said the results are "an important and unexpected result -- we have a new understanding of how HIV can invade the female vaginal tract." He added, "We urgently need new prevention strategies or therapeutics to block the entry of HIV through a woman's genital skin" (BBC News, 12/17).

According to Reuters, researchers in the past have assumed that HIV sought out breaks in the skin -- like a herpes sore -- to gain access to immune system cells deeper in tissue, and some thought the normal lining of the vaginal tract could work as a barrier to transmission during sexual intercourse. Reuters reports that the study "casts doubt" on the theory that HIV transmission requires a break in the skin or that the virus gains access through the cervical canal's single layer of skin cells. The findings also "might explain why some prevention efforts" -- such as diaphragms or herpes treatment -- have "failed," Reuters reports (Reuters, 12/16).

Lisa Power from the Terrence Higgins Trust in the United Kingdom said the results are an "important finding" but "sadly, not surprising" because it has been "long known that it is easier for a man to transmit HIV sexually to a woman than for a woman to transmit it to a man." She added that the study "helps us understand why" and "will help in developing better prevention mechanisms -- but until then, it's more clear than ever that a condom is a vital part of safer sex." The British not-for-profit organization AVERT said that the study "serves to strengthen" the argument for condom use during heterosexual intercourse and "will hopefully give weight to the need for safer heterosexual sex to be advocated further by governments and practitioners worldwide" (BBC News, 12/17). According to Hope, the findings emphasize the importance of methods to prevent transmission, such as a vaccine and condom use. He said, "People need to remember that they are vulnerable. The sad part is if people just used a condom, we wouldn't have this problem" (Reuters, 12/16).

FDA Approves Prezista for Use in Treatment Naive Individuals

FDA on Tuesday approved Johnson & Johnson's protease inhibitor Prezista for use by people who have never taken antiretroviral drugs in the past, the Wall Street Journal reports. FDA in 2006 approved Prezista for HIV-positive people who had developed resistance to other drugs. The agency also granted tentative approval for the drug as part of FDA's accelerated approval mechanism, which allows drugs to be sold while further studies are conducted. J&J obtained full approval for Prezista after submitting studies to FDA through this mechanism (Corbett Dooren, Wall Street Journal, 10/23).

According to J&J, patients beginning HIV treatment should take Prezista -- generically known as darunavir -- in combination with ritonavir. Ritonavir -- sold by Abbott Laboratories under the brand name Norvir -- works in combination with Prezista by slowing down the body's processing of the drug, Reuters reports (Reuters, 10/22). As a protease inhibitor, Prezista works by blocking a protein that HIV requires for replication. Treatment-naive HIV-positive people are recommended to take two 400 mg tablets of Prezista with 100 mg of ritonavir twice daily, and patients who have previously taken other HIV medications are recommended to take 600 mg of Prezista twice daily. J&J will discontinue the production of a 300 mg tablet following a decline in demand. According to the company, the wholesale price of the drug is about $740 monthly.

Glenn Mattes, president of J&J's Tibotec Therapeutics, said FDA approval of Prezista for newly diagnosed HIV-positive people "is a significant expansion of our ability to reach the entire population of patients who should be treated with a protease inhibitor." According to the AP/Boston Globe, during a study that compared Prezista with Kaletra -- a similar drug produced by Abbott -- 84% of patients treated with Prezista had HIV viral loads drop to an undetectable level, compared with 78% of patients taking Kaletra. However, this difference was not considered statistically significant (AP/Boston Globe, 10/22). Side effects of Prezista include diarrhea, headache, nausea, skin rash and, in some cases, hepatitis and liver failure (Reuters, 10/22).

More money needed to reduce the number of new U.S. infections

CDC officials on Tuesday at a House Government Reform and Oversight Committee hearing said they would need an additional $4.8 billion dollars over the next five years to reduce the annual number of new HIV infections in the U.S., CQ HealthBeat reports (Stanchak, CQ HealthBeat, 9/16).

According to the Los Angeles Times, the hearing came after CDC released a study last month that found that about 56,300 new HIV infections occur annually in the U.S. (Dizikes, Los Angeles Times, 9/17).

CDC Director Julie Gerberding based on the new estimates the agency would need an additional $877 million in 2009 to reduce the number of new HIV infections. According to the Times, the fiscal year 2009 budget request for HIV prevention funding is $892 million, which includes $752.6 million requested by CDC. Waxman said that he would try to work with the House Appropriations Committee to increase funding for domestic HIV prevention efforts but added that he is "not very optimistic" the Bush administration will increase funding (Los Angeles Times, 9/17).

Gerberding; Kevin Fenton, director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention; and Anthony Fauci, director of the National Institute for Allergy and Infectious Disease, told the committee that although the additional amount of money requested is high, it could reduce the HIV transmission rate by 50% over 12 years. In addition, the increased funding could help reduce the number of HIV-positive people who are unaware of their status by 50% and help reduce racial disparities.

Gerberding said that the agency would use the increased funding to expand HIV testing, research new prevention techniques and evaluate prevention programs. Fauci added that increased funding also would allow research into new areas of HIV prevention research, such as preventing coinfection with other sexually transmitted infections, providing antiretroviral drugs to HIV-negative people as a preventive measure, testing microbicides and vaccine development.

Although the $4.8 billion request is a significant amount of money, it would be more expensive not to treat HIV, Fauci said. A "professional judgment budget" (.pdf) released by the panelists noted that each HIV infection costs more than $1 million in treatment and lost productivity and that if CDC can prevent 4,800 new infections over five years, the programs established with increased funding would be "cost saving to society."

Gerberding said the request is "not just about funding, it's about needing new tools," adding, "AIDS is a social disease as well as a viral disease ... if we don't address the underpinning issues, we'll never get to where we need to be" (CQ HealthBeat, 9/16). She said that the U.S. "need[s] to do so much more than we're doing right now" to prevent new HIV infections, adding that public health workers "need to get AIDS back on the radar screen" because HIV/AIDS "is still posing a threat to college students and to young men and women across our nation's fabric."

Panelists also called for additional HIV prevention and education programs that target blacks, Hispanics and men who have sex with men. George Ayala of AIDS Project Los Angeles told committee members that only four of CDC's 49 recommended intervention programs specifically target MSM and only one targets minority MSM. He said, "Serious HIV-related health disparities, often fueled by stigma and discrimination, continue to undermine HIV prevention efforts in communities of color" (Los Angeles Times, 9/17).

Rising HIV Prevalence Among MSM in Hong Kong

The senior medical director of Hong Kong's Centre for Health Protection, Raymond Ho Lei-ming, on Tuesday warned residents that HIV prevalence in the region is increasing among men who have sex with men, Hong Kong's Standard reports (Chui, The Standard, 9/17).

According to Ho, a study released last year found that HIV prevalence among MSM in Hong Kong is about 4%, up from a 1% HIV prevalence rate in previous years. Ho said prevalence among MSM in the region could top 30% by 2020 if current trends continue. According to Ho, sex parties and low condom use have been attributed to the increased number of cases. "If we don't do anything, we are looking at a worst-case scenario," Ho said (Benitez, South China Morning Post, 9/17). He called for people at risk of HIV infection to get tested and for greater condom use and other HIV prevention measures (Standard, 9/17).

Loretta Wong Wai-kwan, the CEO of AIDS Concern, a volunteer organization offering HIV/AIDS support and prevention programs in Hong Kong, said that the number of HIV/AIDS clinics in Hong Kong has remained stagnant over the past decade. She added, "How do the existing human resources or facilities cope with the increasing case load?" (South China Morning Post, 9/17).

www.aids-drugs-online.com

Rising HIV Prevalence Among MSM in Hong Kong

The senior medical director of Hong Kong's Centre for Health Protection, Raymond Ho Lei-ming, on Tuesday warned residents that HIV prevalence in the region is increasing among men who have sex with men, Hong Kong's Standard reports (Chui, The Standard, 9/17).

According to Ho, a study released last year found that HIV prevalence among MSM in Hong Kong is about 4%, up from a 1% HIV prevalence rate in previous years. Ho said prevalence among MSM in the region could top 30% by 2020 if current trends continue. According to Ho, sex parties and low condom use have been attributed to the increased number of cases. "If we don't do anything, we are looking at a worst-case scenario," Ho said (Benitez, South China Morning Post, 9/17). He called for people at risk of HIV infection to get tested and for greater condom use and other HIV prevention measures (Standard, 9/17).

Loretta Wong Wai-kwan, the CEO of AIDS Concern, a volunteer organization offering HIV/AIDS support and prevention programs in Hong Kong, said that the number of HIV/AIDS clinics in Hong Kong has remained stagnant over the past decade. She added, "How do the existing human resources or facilities cope with the increasing case load?" (South China Morning Post, 9/17).

http://www.aids-drugs-online.com

Doctor's advice on Viraday - Taken from thebody.com

How long they live with Viraday? Apr 10, 2007 The patient found CD4 at 8 and viral load at 350,000 started treatment by taking medicine of "Viraday" (Cipla company). By continuing the treatment how long the patient can live? What are the cautions to be taken by the patient? Response from Dr. Pierone Viraday is a combination of Viread, Emtriva, and Sustiva, the same components which are in Atripla. This combination agent leads to an undetectable viral load and increases in CD4+ lymphocyte counts in the great majority of patients. AIDS is a chronic, manageable disease for people who have access to potent combination therapy like this. The expectation is that individuals on successful treatment for HIV infection and AIDS will have a normal or near normal lifespan. The precautions for this medication would mainly be for the Sustiva component of this medication which produces neuro-cognitive adverse events more than half of the time, but these effects tend to dissipate after the first several weeks. Viread can produce kidney problems, but not commonly, and usually in patients who already have kidney problems or are on other medications with kidney toxicity. I hope that this information helps and best of luck!

The Bronx to Test Everyone for HIV/AIDS

The New York City Department of Health and Mental Hygiene on Friday will begin a three-year effort to test every adult living in the Bronx -- which has the highest rate of HIV/AIDS-related deaths in the city -- for HIV, the New York Times reports. According to the Times, the campaign will initially work to make voluntary testing routine in emergency rooms and storefront clinics, where city officials say that state consent procedures deter physicians from offering the tests. City Health Commissioner Thomas Frieden said that routine testing "would mean if you came into the emergency room for asthma or a broken leg, we test everyone for HIV, if they're willing."

Although Manhattan has the highest incidence of HIV/AIDS cases in the city, the Bronx, which has a lower-income population, reports more deaths from the disease. Public health officials say the high mortality rate is associated with people not getting tested until it is too late to effectively treat the virus. According to city officials, 40% of the borough's 830,000 people ages 18 to 64 have undergone HIV testing in the past year, and half of the remainder, about 250,000, have never been tested. The campaign intends to first test this group at 40 designated sites, including clinics, community centers, churches and emergency rooms. Monica Sweeney, an assistant health commissioner for HIV prevention, said the city has not set aside money specifically for the program, but that it would absorb the $12 cost of each test.

The Times reports that several HIV/AIDS experts have described the effort as the most aggressive in the country. Donna Futterman -- director of Montefiore Medical Center's Adolescent AIDS Program in the Bronx, which helped New York City develop the program -- said, "What's new here is that we are implementing it on this large a level," adding, "The Bronx has 1.3 million people. It's bigger than most cities, bigger than Boston, bigger than Washington. We're talking about a significant urban population." Frieden -- who has enlisted the support of Bronx elected officials, health care providers and clergy members -- said the health department chose the Bronx because it has good relationships with clinics and hospitals there. City officials also said that Bronx residents already are more likely to be tested than adults in other boroughs.

However, Frieden said the efforts come after years of lobbying to overhaul strict state regulations -- which have changed little since HIV/AIDS was first discovered in the 1980s -- that require patients to give written permission for testing after being counseled on the process. According to Frieden, New York's consent law is one of the strictest in the country; CDC recommends that written consent and pretest counseling requirements be dropped.

Futterman said that she hopes that making HIV testing routine by including the test as part of a patient's blood work will change the mentality surrounding the test and spur state legislators to ease consent rules. "Everything in AIDS has changed except the old testing paradigm," she said, adding, "Old school was that you had to tell them everything that could happen. That starts to seem cruel. If you go for cancer diagnosis, they don't make the doctor say what you're going to do if your mammogram is positive."

According to the Times, under the new initiative, hospital administrators in the Bronx have agreed to test in emergency departments, where physicians have felt the requirement interferes with more immediate health needs, but still follow state consent laws. Futterman said she has carefully constructed a script for physicians that follows state law but condenses what is typically a 20-minute counseling and consent process into five minutes. She added that using the process has helped her increase the proportion of her patients being tested to between 20% and 25%, up from 10%.

In an attempt to make HIV testing less intimidating, the city also will issue public service announcements and information on its 311 hotline. It also is posting tear-off sheets with addresses of testing centers in places like check-cashing stores, where residents can discreetly slip them into pockets. Sweeney said, "It's not about one group doing it, it's about everybody doing it." Community organizations, universities, churches and politicians are going to have all their constituents that come to them for other services, they're going to use it as an opportunity to say, 'Get your HIV test'" (Hartocollis, New York Times, 6/26).

The Quality Standards for Generic Drugs

Are Discount Drugs of Inferior Quality?

"Most people believe that if something costs more, it has to be better quality..."says Gary Buehler, Director of FDA's Office of Generic Drugs. "In the case of generics (discount drugs), this is not true. The standards for quality are the same for brand name and generic products." (1)

When a brand name product has a generic competitor, this simply means that the brand name product has been around long enough for its patent to expire, which then allows generics (copy discount drugs) to be made. Most often generics will be the discount drugs found in these markets, and almost always they will be less expensive prescription drugs when compared to their brand name counterparts.

Despite their lower price, manufacturers of generic prescription drugs are required to meet rigorous quality standards before they can sell their generic 'discount drugs'. Pharmacies who source high quality generic products only from pharmaceutical manufacturers that comply with these strict international regulatory standards are providing quality alternatives to the branded equivalent. The quality standards of the lower cost generic products available are as high as they are for the most expensive original brand name drugs .

While the active ingredients in generic prescription drugs are the same as the active ingredients in their brand name counterparts, there may be differences in their appearance. (For example, the shape or the colour of a tablet.)

Sometimes different non-active ingredients may used to produce the final product. (For example, the non-active base in creams or diluents in nasal sprays.) However, the active ingredients, which give a drug its intended effect, are the same in generic prescription drugs and their brand name counterparts. None of these differences should alter the clinical effect of any approved generic discount drug.

The Current Use of Generic Prescription Drugs

The U.S. drug regulatory authority, the FDA, has approved more than 7000 generic discount drugs for use in the U.S. The approval process that all of these generic prescriptions drugs have completed is extremely intensive and multi-faceted. It covers quality, performance and labelling. Also, while these generics will inevitably become the country's discount drugs, the manufacturing facilities where they are to be made, are required by the FDA to be as good as those used to manufacture brand name drugs. This standard applies no matter where in the world the manufacturing facility is located.

Almost half of the prescriptions filled in 2002 in the U.S. were for generic drugs (1), these being the discount drugs of the country. This strong and growing demand for generic prescription drugs is testimony to their widespread acceptance by the health authorities, health professionals, and patients.

Pharmacies source high quality generic products only from pharmaceutical manufacturers that comply with strict international manufacturing standards. This means that any generic product supplied to a customer has complied with robust internationally accepted quality standards.


Some of the generic products sourced from internationally approved pharmaceutical manufacturers from India. The key companies that supply Indian generic pharmaceuticals are:

• Dr Reddy's Laboratories Limited

• Cipla Limited

The links provided will take you to the respective company websites which have information to show that their manufacturing facilities have been inspected to meet the robust standards of the FDA as well as other internationally recognised regulatory authorities.

Some Technical Facts About The Generic Drug Approval Process

In the U.S and most developed countries generic drugs must show that they:

• Contain the same active ingredients as the brand name drug (inactive ingredients may vary)

• Are identical in strength, dosage, form, and route of administration

• Are used for the same condition(s)

• Are bio-equivalent (that is, they are available to the same extent in the body when taken or administered)

• Meet the same batch requirements for identity, strength, purity, and quality

• Are manufactured under the same strict standards of the FDA's good manufacturing practice as required for brand name products. (1)

Useful Links

To read more about the FDA standards for generic drugs click on the following links. http://www.fda.gov/opacom/factsheets/justthefacts/18generic.html
http://www.fda.gov/cder/about/whatwedo/testtube-17.pdf

FDA Approved AIDS Drugs

For those seeking treatment options, below is a listing of medications available in the USA. Please note that this list is not 100% complete, and does not include all possible available or recently approved medications. Also, it is possible to buy some of these medicines as generics and as such they would have different names.

• Agenerase (amprenavir) - Protease inhibitor.
• Aptivus® (tipranavir) - Protease inhibitor.
• Atripla; Three pills in one; combines the active ingredients of Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate).
• Combivir -combination of Retrovir (300mg) and Epivir (150mg) - together in the same tablet for convenience.
• Crixivan (indinavir) - protease inhibitor.
• Emtriva [ emtricitabine (FTC).
• Epivir (3tc / lamivudine) - nucleoside analog reverse transcriptase inhibitor
• Epzicom ( a combination of 2 nucleoside reverse transcriptase inhibitors (NRTIs in the same pill; 600mg of Ziagen (abacavir) and 300mg of Epivir (3TC).
• Fortovase (saquinavir) - protease inhibitor.
• Fuzeon (enfuvirtide) - Fusion inhibitor.
• Isentress (raltegravir) Integrase Inhibitor.
• Invirase (saquinavir) - protease inhibitor.
• Kaletra (lopinavir) - protease inhibitor.
• Lexiva (Fosamprenavir) - Protease Inhibitor approved 10/20/03
  Formerly known as GW-433908 or VX-175
  Improved version of Agenerase ( amprenavir); supposed to be fewer pills per day and fewer GI Side effects.
• Norvir (ritonavir) - protease inhibitor.
• PREZISTA (darunavir) tablets. - protease inhibitor;
  used when other protease inhibitors don't work any more.
• Rescriptor (delavirdine) - non nucleoside analog reverse transcriptase inhibitor.
• Retrovir, AZT (zidovudine) - nucleoside analog reverse transcriptase inhibitor.
• Reyataz (atazanavir; BMS-232632) - protease inhibitor.
• Sustiva (efavirenz) - non nucleoside analog reverse transcriptase.
• Trizivir (3 non nucleosides in one tablet ; abacavir + zidovudine + lamivudine.
• Truvada (Emtricitabine + Tenofovir DF )
  Combination of 2 nucleoside reverse transcriptase inhibitor (NRTI's in one pill).
• Videx (ddl / didanosine) nucleoside analog reverse transcriptase inhibitor.
• Viracept (nelfinavir) - protease inhibitor.
• Viramune (nevirapine) - non nucleoside analog Reverse transcriptase inhibitor.
• Viread (tenofovir disoproxil fumarate) Nucleotide Reverse transcriptase inhibitor ( Adenosine Class).
• Zerit (d4t / stavudine) - nucleoside analog reverse transcriptase inhibitor.
• Ziagen (abacavir) - nucleoside analog reverse transcriptase inhibitor.

AIDS-Drugs-Online.com

WHO Director-General Chan Calls on Member States To Make Antiretrovirals, Other Medications More Affordable

World Health Organization Director-General Margaret Chan on Monday at a meeting of WHO's Intergovernmental Working Group on public health in Geneva called on developed countries to make antiretroviral drugs and other medications more affordable for developing countries, the AP/Tacoma News Tribune reports. WHO's 193 member states by the end of the week hope to develop a strategy on drug development, patenting and pricing, according to the AP/News Tribune.

Chan at the meeting said she is aware that the "price of medicines and other products can be prohibitive, effectively blocking access to care," but she added that innovation is needed. "Resistance develops and drugs fail, creating an urgent need for second- and third-line medicines," Chan said, adding, "We have seen this problem most acutely with HIV/AIDS. We are seeing it again with the spread of extensively drug-resistant tuberculosis, which is far more costly and difficult to treat" (Klapper, AP/Tacoma News Tribune, 11/5).

Chan said, "The challenge is to work on multiple fronts: to meet the immediate need for equitable access to quality, affordable medicines, while also, at the same time, working to stimulate innovation." She added that the global health community "cannot allow the costs of health care to drive impoverished households even deeper into poverty."

Working Group
According to AFP/Yahoo! News, the working group was set up last year after a WHO-commissioned report called on pharmaceutical companies to reduce prices of drugs sold in developing countries. Some companies have said they already have reduced prices, and the International Federation of Pharmaceutical Manufacturers and Associations has said that drug price and patent issues fall under World Trade Organization jurisdiction and not WHO.

According to U.S. documents obtained by the lobby group Knowledge Ecology International, the U.S. urged countries attending the weeklong meeting to respect existing WTO commitments and not extend WHO's mandate. The U.S. "would like you to make sure you are aware of the potentially negative trade and intellectual property implications that could arise from this initiative" at WHO, the document said. James Love, director of KEI, said the U.S. and European Union are playing a "cynical game" in attempting to break the consensus toward making drugs more affordable (AFP/Yahoo! News, 11/5).

Related Opinion Pieces
Two newspapers on Tuesday published opinion pieces in response to the WHO meeting. Summaries appear below.

* Franklin Cudjoe, Wall Street Journal: Inadequate infrastructure, not price, is the "chief obstacle blocking access of high-quality medicine" in developing countries, Cudjoe, executive director of the Imani Center for Policy and Education, writes in a Journal opinion piece. "If the West is any guide, better health systems come with economic development and higher standards of living," both of which are "frequently stifled" in developing countries by "destructive policies and home-grown corruption," Cudjoe writes. "Let's hope the WHO won't succumb to the misconception that compulsory license can cure Africa's health problems," Cudjoe writes, concluding that "economic development remains the continent's best hope for eradicating the diseases of poverty" (Cudjoe, Wall Street Journal, 11/6).

* Jeremiah Norris, Taipei Times: WHO member states "need to knock this treaty on the head ... before the WHO does lasting damage to global public health," Norris, director of the Center for Science in Public Policy at the Hudson Institute, writes in a Times opinion piece. According to Norris, WHO "aims to weaken intellectual property further and to bring research and development under the control of governments and international bodies," adding that "past evidence shows that nationalizing any business stifles innovation and that it would hinder future efforts to create drugs" for developing countries (Norris, Taipei Times, 11/4).

AIDS Vaccine

Merck's Experimental AIDS Vaccine Fails

By LINDA A. JOHNSON – Sep 22, 2007

TRENTON, N.J. (AP) — In a disappointing setback, a promising experimental AIDS vaccine failed to work in a large international test, leading the developer to halt the study. Merck & Co. said Friday that it is ending enrollment and vaccination of volunteers in the study, which was partly funded by the National Institutes of Health.

It was a high-profile failure in the daunting quest to develop a vaccine to prevent AIDS. Merck's vaccine was the farthest along and was closely watched by experts in the field.

Officials at the company, based in Whitehouse Station, N.J., said 24 of 741 volunteers who got the vaccine in one segment of the experiment later became infected with HIV, the virus that causes AIDS. In a comparison group of volunteers who got dummy shots, 21 of 762 participants also became infected.

"It's very disappointing news," said Keith Gottesdiener, head of Merck's clinical infectious disease and vaccine research group. "A major effort to develop a vaccine for HIV really did not deliver on the promise."

Michael Zwick, an HIV researcher at Scripps Research Institute, said the vaccine's failure is unfortunate. But he said it's too soon to know if other vaccines using the same strategy would also fail.

"It's par for the course in the HIV field," he said of the Merck result.

The volunteers in the experiment were all free of HIV at the start. But they were at high risk for getting the virus: Most were homosexual men or female sex workers. They were all repeatedly counseled about how to reduce their risk of HIV infections, including use of condoms, according to Merck.

In a statement, the NIH said a data safety monitoring board, reviewing interim results, found the vaccine did not prevent HIV infection. Nor did it limit severity of the disease "in those who become infected with HIV as a result of their own behaviors that exposed them to the virus" — another goal of the study.

Merck's was the first major test of a new strategy to prevent HIV infection. The first wave of attempts to develop a vaccine tried to stimulate antibodies against the virus, but that hasn't worked so far.

The new effort — an approach that Gottesdiener said is being tried in most other current research — is aimed at making the body produce more of a crucial immune cell called killer T cells. The goal is to simultaneously "train" those cells, like an army, to quickly recognize and destroy the AIDS virus when it enters cells in the bloodstream.

Zwick said some researchers still are working on vaccines to neutralize the AIDS virus. He thinks ultimately what's needed is one that combines that approach with a way to stimulate and train killer T cells.

Merck and the HIV Vaccine Trials Network, an international collaboration of researchers and institutions funded by the NIH, co-sponsored the study. The experiment, called STEP, began in December 2004 and had enrolled 3,000 volunteers in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico and the United States.

The results announced Friday involved volunteers who researchers thought would benefit most because they had never been exposed to the particular cold virus used in the vaccine.

Wall Street, on a generally upbeat day, showed little reaction to the news, with Merck shares rising 44 cents to $51.82.

Analyst Steve Brozak of WBB Securities said the vaccine was considered the most promising candidate both by Wall Street and the science community. He said a vaccine is the only financially feasible way to fight the AIDS epidemic in poor countries and that the company that comes up with the first successful shot would have "a license to print money."

"You're talking about a Carl Sagan kind of number — billions and billions" of dollars, he said.

The Merck vaccine, known only as V520, also was being tested in a similar study in South Africa and in two smaller studies, which also were halted.

The Merck vaccine failure is a "deep disappointment and a scientific setback for the AIDS vaccine field," the AIDS Vaccine Advocacy Coalition said in a statement. However, the nonprofit group added that "while this is a disappointment, it is in no way the end of the search for an AIDS vaccine."

((Considering that the vaccine has failed, there are still several viable and inexpensive treatment options available at AIDS Drugs Online))

AIDS Vaccine

Merck's Experimental AIDS Vaccine Fails

By LINDA A. JOHNSON – Sep 22, 2007

TRENTON, N.J. (AP) — In a disappointing setback, a promising experimental AIDS vaccine failed to work in a large international test, leading the developer to halt the study. Merck & Co. said Friday that it is ending enrollment and vaccination of volunteers in the study, which was partly funded by the National Institutes of Health.

It was a high-profile failure in the daunting quest to develop a vaccine to prevent AIDS. Merck's vaccine was the farthest along and was closely watched by experts in the field.

Officials at the company, based in Whitehouse Station, N.J., said 24 of 741 volunteers who got the vaccine in one segment of the experiment later became infected with HIV, the virus that causes AIDS. In a comparison group of volunteers who got dummy shots, 21 of 762 participants also became infected.

"It's very disappointing news," said Keith Gottesdiener, head of Merck's clinical infectious disease and vaccine research group. "A major effort to develop a vaccine for HIV really did not deliver on the promise."

Michael Zwick, an HIV researcher at Scripps Research Institute, said the vaccine's failure is unfortunate. But he said it's too soon to know if other vaccines using the same strategy would also fail.

"It's par for the course in the HIV field," he said of the Merck result.

The volunteers in the experiment were all free of HIV at the start. But they were at high risk for getting the virus: Most were homosexual men or female sex workers. They were all repeatedly counseled about how to reduce their risk of HIV infections, including use of condoms, according to Merck.

In a statement, the NIH said a data safety monitoring board, reviewing interim results, found the vaccine did not prevent HIV infection. Nor did it limit severity of the disease "in those who become infected with HIV as a result of their own behaviors that exposed them to the virus" — another goal of the study.

Merck's was the first major test of a new strategy to prevent HIV infection. The first wave of attempts to develop a vaccine tried to stimulate antibodies against the virus, but that hasn't worked so far.

The new effort — an approach that Gottesdiener said is being tried in most other current research — is aimed at making the body produce more of a crucial immune cell called killer T cells. The goal is to simultaneously "train" those cells, like an army, to quickly recognize and destroy the AIDS virus when it enters cells in the bloodstream.

Zwick said some researchers still are working on vaccines to neutralize the AIDS virus. He thinks ultimately what's needed is one that combines that approach with a way to stimulate and train killer T cells.

Merck and the HIV Vaccine Trials Network, an international collaboration of researchers and institutions funded by the NIH, co-sponsored the study. The experiment, called STEP, began in December 2004 and had enrolled 3,000 volunteers in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico and the United States.

The results announced Friday involved volunteers who researchers thought would benefit most because they had never been exposed to the particular cold virus used in the vaccine.

Wall Street, on a generally upbeat day, showed little reaction to the news, with Merck shares rising 44 cents to $51.82.

Analyst Steve Brozak of WBB Securities said the vaccine was considered the most promising candidate both by Wall Street and the science community. He said a vaccine is the only financially feasible way to fight the AIDS epidemic in poor countries and that the company that comes up with the first successful shot would have "a license to print money."

"You're talking about a Carl Sagan kind of number — billions and billions" of dollars, he said.

The Merck vaccine, known only as V520, also was being tested in a similar study in South Africa and in two smaller studies, which also were halted.

The Merck vaccine failure is a "deep disappointment and a scientific setback for the AIDS vaccine field," the AIDS Vaccine Advocacy Coalition said in a statement. However, the nonprofit group added that "while this is a disappointment, it is in no way the end of the search for an AIDS vaccine."

((Considering that the vaccine has failed, there are still several viable and inexpensive treatment options available at www.aids-drugs-online.com))

Cipla launches 3-in-1 AIDS drug in India

Cipla has launched an innovative combination of 3 HIV/AIDS drugs, Viraday that needs to be taken just once a day for effective treatment.

The three anti-HIV drugs efavirenz 600 mg, tenofovir 300 mg and emtricitabine 200mg comprise the drug Viraday. Viraday, one tablet of which alone effectively treats a HIV infected person, eliminates the need for 3 separate medicines. This drug has some advantages like, it is less burdensome and it can be taken along with tuberculosis medicines, which could not be done previously.

This combination drug, that was previously available only in the U.S. and European countries, was first launched in India by Cipla on Thursday. In the U.S. and Europe this combination drug costs Rs. 52,800 a month, whereas Cipla will make it accessible at just Rs. 5,200 per month. This combination drug is less toxic than when the drugs are taken separately.

This breakthrough would improve the adherence-how faithfully patients stick to the course of treatment advised by the doctor. “This is a vital issue in HIV treatment to prevent the infection from reaching the advanced stage of AIDS,” said senior consultant in Internal Medicine at Indraprastha Apollo Hospital, Dr Nalin Nag. He said, “Viraday is very patient friendly, as it requires just one pill a day and freedom from the severe side effect of many other anti HIV drugs.”

The innovative treatment kits and the 3-in-1 pills introduced by Cipla will promote adherence and ease of use. Viraday is the most remarkable accomplishment of Cipla.

Cipla has brought down the price of HIV/AIDS drugs in international market. It supplies HIV/AIDS drugs to majority of African, South Asian, Latin American and several other developing countries.

Source-Medindia
GYT

Find Viraday available at www.aids-drugs-online.com