AIDS Treatment as a form of Prevention

A lot of people thought Julio Montaner was a little crazy when he first suggested that the best way to eliminate the AIDS epidemic would be a massive scheme to give AIDS medicine to every infected person.

What about the huge financial cost? What about the moral issues, the human-rights issues, the overwhelming number of tests and drugs that would be required? Wouldn't it undermine years of lecturing on monogamy and abstinence? Wouldn't it promote "condom-free sex," as some critics said?

Faced with a host of objections, the Canadian scientist was a lone voice in the wilderness for the past three years, unable to win support from the global AIDS establishment.

But this year, Dr. Montaner's solitary crusade - the controversial notion of "treatment as prevention" - has suddenly become one of the hottest issues in AIDS science. And yesterday, at the International AIDS Society conference in Cape Town, his once-ridiculed idea was endorsed by experts from around the world.

Among the latest support for his proposal is a model by World Health Organization researchers that predicts a 95-per-cent reduction in new HIV cases within 10 years if his idea is adopted.

The proposed new strategy - universal voluntary testing for HIV, combined with immediate anti-retroviral drug treatment for those who have the virus, even in its earliest stages - could save more than seven million lives by 2050, the model says.

The WHO, which had resisted the treatment-as-prevention concept for years, is now organizing a special conference this November to discuss the "feasibility and acceptability" of the concept.

"Treatment as prevention is the topic of the year," Swiss scientist Bernard Hirschel told the AIDS conference yesterday.

"I think Julio deserves a lot of credit for this. Is treatment going to be the answer? We don't know, but we'd better find out."

Dr. Montaner, president of the International AIDS Society and director of the B.C. Centre for Excellence in HIV/AIDS, has been a prominent scientific researcher on AIDS since 1981, before the virus was even identified. A pioneer in the use of anti-retrovirals and other AIDS drugs, he has been campaigning for the treatment-as-prevention strategy since 2006.

Willy Rozenbaum, one of the early discoverers of the AIDS virus and now the president of France's National AIDS Council, was another scientist who lent his support to Dr. Montaner yesterday. Providing proper treatment to those who have the AIDS virus "sharply reduces the chances that they will transmit the virus," he told the conference.

Dr. Rozenbaum acknowledged that researchers must study whether the use of medical treatment as a prevention strategy would encourage "risky" behaviour by those who think that the AIDS virus has been virtually eliminated from their bodies. But medical treatment and condom use can coexist, he said.

In an interview, Dr. Rozenbaum said the notion of treatment as prevention is being resisted by many governments because they are afraid of the cost and reluctant to admit the failure of the traditional prescription of condoms and monogamy. "They've been promoting condoms as the answer for 20 years," he said.

After initial progress in reducing AIDS in the developed world, the condom strategy has failed to make further progress in recent years, he said. "I'm not happy with a plateau. We can't accept just a stabilization of the problem."

As for the short-term financial cost of a massive expansion in AIDS medicine, it would be outweighed by savings within five or 10 years as the transmission rate is swiftly reduced, he said.

The new WHO model of how this strategy could work, presented at the conference by WHO researcher Reuben Granich, says the treatment strategy would drive up costs at first, but "may provide cost savings" in the long run as it increasingly prevents new HIV cases.

Dr. Montaner conceded that some "recalcitrant" people with the AIDS virus will refuse to be tested or treated. His plan would not force them to be tested, but this would not weaken the strategy, he said.

"A person who is appropriately treated becomes dramatically less likely to transmit," he said. "The more you treat, the more you reduce the cases. ... When we first suggested this in 2006, people thought we were a little loony. But it's now fully accepted. We just need to get started."

The notion of treatment as prevention "creates a powerful new rationale" for the expanded use of anti-retrovirals and other AIDS drugs, he said. "We have transformed treatment from being merely a life-saving tool. Now it means we are protecting society, we are protecting our children."

The Harper government in Ottawa is still resisting the proposed new strategy, even as global experts are accepting it, Dr. Montaner said. When he suggested the strategy in a letter to the federal Health Minister, he received only a form letter in response. "It's been increasingly adopted around the world, but where is Canada on this?"

*****

The global AIDS battle

World health leaders are gathering in South Africa to discuss ways to fight the disease

PEOPLE WITH HIV/AIDS AROUND THE WORLD

PERCENTAGE OF WORLD TOTAL/ 2007

Latin America and the Caribbean/ 5.0%

High-income countries/ 5.4%

Eastern Europe and Central Asia/ 3.9%

Asia/ 21.4%

Africa/ 64.4%

The overwhelming majority of people with HIV/AIDS, 95%, live in the developing world.

MONEY AVAILABLE FOR GLOBAL AIDS FIGHT, IN BILLIONS $ US

'05/ $7.9

'06/ $8.8

'07/ $11.3

"08/ $13.8

THE GLOBE AND MAIL / SOURCE: UNAIDS, AVERT.ORG

HIV Vaccine Ready for Human Tests

An HIV/AIDS vaccine developed in Canada has passed safety tests in animals and the researchers are awaiting approval to begin human trials in the U.S.

"It is a very important milestone for us," said Yong Kang, a professor of microbiology at the University of Western Ontario in London who has been working on the vaccine for 20 years.

Kang said he expects to get the go-ahead soon from the U.S. Food and Drug Administration to begin human toxicology tests and two phases of clinical trials in the United States.

If all three trials are successful, the vaccine should be available within the next decade, Kang told CBC News on the phone while attending a meeting in South Korea.

According to a 2008 United Nations report on the global AIDS epidemic, 33 million people were living with HIV in 2007. Two million people died of causes related to the disease that year.

Dozens of HIV vaccines have already been developed and tested in animal models, but few have been tested in humans, none successfully. A promising trial in 2007 by pharmaceutical giant Merck and Co. was shut down after those receiving the vaccine contracted HIV at a higher rate than those who received the placebo.

Kang has partnered with a Curacom, a South Korean holding company, that has agreed to open an office in London, Ont., to help fund research in Kang's lab and commercialize the vaccine.

A test vaccine is being manufactured in a lab in Maryland near Washington, D.C.

Lab tests showed the vaccine produced no adverse effects or safety risks during immunology tests on animals.

The toxicology tests are expected to include 40 to 50 HIV-positive volunteers in the U.S., and will be designed to test whether the vaccine is toxic in humans.

http://www.cbc.ca/health/story/2009/07/01/health-canadian-aids-hiv-vaccine-kang.html

Microbicide Containing Natural Compound Provides Protection in Monkeys Against Simian Version of HIV

An experimental microbicide containing a naturally occurring compound provides protection in monkeys against the simian version of HIV by diminishing immune responses to the virus, according to a study published Wednesday in the journal Nature, the Los Angeles Times reports. HIV typically spreads in the body by entering CD4+ T cells, which the immune system sends out to attack the virus after exposure. The compound -- called glycerol monolaurate, or GML -- works by inhibiting immune signals that dispatch the T cells to attack the infection. It is those T cells that HIV infects and uses to proliferate throughout the body (Engel, Los Angeles Times, 3/5). GML occurs naturally in the human body and already is approved for use as an antimicrobial and anti-inflammatory ingredient in cosmetics and toiletries, as well as an emulsifier in foods. In addition, each dose of GML used in the study costs less than one cent. According to the researchers, the study's findings have promising implications for the development of effective microbicides to prevent HIV (AFP/Google.com, 3/4).

For the study -- led by Ashley Haase, head of the microbiology department at the University of Minnesota Medical School, and microbiologist Patrick Schlievert -- researchers administered the GML gel vaginally to five rhesus monkeys and then repeatedly exposed them to the simian version of HIV, or SIV. After two weeks, all of the five monkeys tested negative for the virus. However, four out of five monkeys that did not receive the GML gel contracted SIV. According to the researchers, five months after the experiment, they learned that one of the monkeys treated with GML tested positive for the virus. The researchers said they are unsure how this monkey contracted SIV, but they suggested that a small amount of the virus might have spread in the body undetected or the monkey might have been exposed to SIV after the study ended (Lerner, Minneapolis Star Tribune , 3/4).

Haase said the current research is "a relatively preliminary study but worth sharing because it establishes a novel approach." The researchers added that a mathematical model suggests that even if the microbicide were 60% effective and used 20% of the time, it still could prevent about 2.3 million HIV cases over a three-year period. According to the study authors, researchers will need to conduct further animal studies to determine whether the microbicide should be administered over a longer period of time to provide long-term protection against the virus (Los Angeles Times, 3/5). Further study also will be needed to demonstrate whether GML prevents HIV transmission among humans, they added. The researchers said they plan to undertake a larger study with monkeys, followed by a study with female volunteers. In addition, the University of Minnesota has applied for patents for the new compound combining GML with a personal lubricant, which currently is not available commercially. According to Schlievert, the ultimate goal will be to develop a gel that can be used for both men and women (Minneapolis Star Tribune, 3/4).

According to the study authors, the research "represents a highly encouraging new lead in the search for an effective microbicide to prevent HIV transmission that meets the criteria of safety, affordability and efficacy" (Fox, Reuters, 3/4). Haase said that although the research "sounds counter-intuitive, halting the body's natural defense system might actually prevent transmission and rapid spread of the infection" (AFP/Google.com, 3/4). Charlene Dezzutti, laboratory network director of the Microbicides Trial Network at the University of Pittsburgh, said the research illustrates "a new approach to thinking about microbicides." She added that she believes scientists "definitely" could develop an effective microbicide before developing an HIV/AIDS vaccine. "It's just a matter of getting all the right pieces together," she said (Lauerman, Bloomberg, 3/4). Rowena Johnston, vice president of research for the Foundation for AIDS Research, said that if further studies confirm these results, "then this is really a fabulous new finding." She said that although future microbicide research could encounter setbacks, the study is "absolutely a great beginning to a research project."

According to Schlievert, women could apply the GML microbicide "an hour or so before they had sex" to protect against HIV transmission. In addition, the gel might provide protection against other sexually transmitted infections, such as chlamydia, he said (Minneapolis Star Tribune, 3/4). According to AFP/Google.com, Schlievert first identified the microbicidal properties of GML when studying the use of the compound in preventing toxic shock syndrome associated with tampons. He said research repeatedly has found that the compound is safe and has no effect on beneficial vaginal bacteria (AFP/Google.com, 3/4). Lorraine Teel, executive director of the Minnesota AIDS Project, said the gel could provide women with a way to prevent disease transmission in areas of the world where many people do not use condoms because of cultural or other pressures. The research has "absolutely enormous implications" for women worldwide, she said (Minneapolis Star Tribune, 3/4). Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, said an effective microbicide would "empower women to protect themselves in a sexual situation in which they may not have complete control" (Los Angeles Times, 3/5).

An abstract of the study is available online.

Texas Bill To Make HIV Screening Part of Routine Care Would Help Efforts To Curb Virus

"More than two years after" CDC "recommended routine HIV screening, two state lawmakers" in Texas have proposed a bill to align the state with the federal recommendations, a Lubbock Avalanche-Journal editorial says. It adds that between 2003 and 2007, "more than one-fourth of Texans with HIV were diagnosed late in the course of the disease and were diagnosed with AIDS within a month." According to Ed Sherwood, chair of the Texas Medical Association Committee on Infectious Diseases, making HIV tests a part of routine care "would help avoid situations where patients assume they couldn't be infected and decide not to get tested," the editorial says. In addition, if the legislation "passes, it will be a model for other states," according to bill sponsor Sen. Rodney Ellis (D), the editorial says, adding, "California and Illinois are the only other states to pass HIV screening legislation, but not as comprehensive."

The state "already has legislation requiring inmates in Texas prisons to be tested for HIV when they enter and leave the system," according to the editorial. It adds that state law "also requires doctors to offer HIV screening at checkups for pregnant" women. The editorial concludes that the bill is a "good idea ... as long as people can opt out" (Lubbock Avalanche-Journal, 3/4).

New Orleans Officials Should Ensure That 'Glitch' in Ryan White Process Will Not Create 'Problem' With 2009 Grants

"The grant process for agencies working with" HIV-positive people is "maddening," a New Orleans Times-Picayune editorial says. According to the editorial, it "took six months" for Mayor Ray Nagin's administration to "distribute $7 million in federal grant money this year," and the city's Office of Health Policy "received the money" from the Ryan White Program in March but did not "send out grant award notices to agencies until June." It adds that contracts were not "finalized until last month."

Following criticism from the City Council on the "slow-moving process," Health Policy Director Fran Lawless "promised that her office would do better with the next round of grants," the editorial says, adding, "Unfortunately, that hasn't been the case so far." According to the editorial, a "public notice published last week to launch the 2009 process included errors that forced the city to cancel the effort and push back its start." It adds, "Even the best operations can make the type of clerical errors in the failed notice. And there are points in the public notice process where things can occasionally go wrong." However, "these problems are worrisome considering the office's history of delays," the editorial says, adding that Nagin "needs to make sure the office's director and employees can efficiently accomplish this task or find some who can." Concerns from officials involved with the grant process "surely pal[e] in comparison with the anguish of more than 4,000 people with HIV/AIDS who get treatment and case management services from the entities that the grants fund," according to the editorial. It adds, "At least one of those agencies had to close during the summer because of the city's delays. That left hundreds of people without the help they need." The editorial concludes that city "officials promise that the glitch in the process won't cause a problem with the 2009 grants. They need to ensure that it doesn't" (New Orleans Times-Picayune, 12/22).

In the event that service disruptions affect your health care management plan, be sure to visit http://www.aids-drugs-online.com

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).

Young Travellers in Australia at Higher HIV Exposure Risk

HIV-positive people receiving treatment for the virus might be at an increased risk of developing heart disease and type 2 diabetes because some antiretroviral drugs can cause fat on the arms, legs, face and buttocks to move to the stomach, researchers at Australia's Garvan Institute said Monday, the Sydney Morning Herald reports. According to the Herald, excess weight around the waist can increase a person's chances of developing cardiovascular and metabolic disorders, but physicians say newer classes of drugs, which do not cause fat redistribution, are too expensive for most people.

Katherine Samaras -- lead author of the study, which was published in the journal Obesity -- said the findings indicate that older antiretrovirals, still commonly used in Australia, can give many HIV-positive patients the same level of heart disease risk seen in obese people with sedentary lifestyles. The Herald also reports the study found that antiretrovirals can cause fat cells to create inflammatory molecules promoting certain diseases. Samaras said, "When fat cells are healthy, they help maintain our metabolism, but if they become too large or are affected by drugs, such as HIV medications, they can produce" numerous chemicals linked to heart disease. She added, "We also have the problem that the older drugs are off-patent now and very cheap, so they are the frontline treatment" in developing countries. According to Samaras, "There are drugs on the market which do not have these side effects, but they are not yet on" Australia's pharmaceutical benefits programs and are "too expensive for most people. The primary concern is to optimize viral suppression, that is reduce the virus load in the body, to minimize its effects." She added that physicians should ensure that their HIV-positive patients are regularly screened for diabetes (Benson, Sydney Morning Herald, 11/18).

Global Financial Crisis Could Adversely Effect AIDS Funding

The current global financial crisis could harm HIV/AIDS funding and increase the factors that make people vulnerable to the disease, UNAIDS Executive Director Peter Piot said on Tuesday during an event at the Center for Strategic and International Studies, CQ HealthBeat reports. According to Piot, as rising food and energy costs drive more people into poverty worldwide, the factors that drive the spread of HIV also could increase. "That must have an impact on the spread of HIV, although it's not so clear," he said, adding that it is certain that low-income countries will be more affected by and vulnerable to the financial crisis when it comes to providing HIV/AIDS treatment. For example, 100% of the cost to provide 50,000 HIV-positive people in Rwanda with antiretroviral drugs at the end of last year was paid by donors -- such as the Global Fund To Fight AIDS, Tuberculosis and Malaria and the President's Emergency Plan for AIDS Relief -- according to Piot. He added that Brazil receives no donor funding to provide similar treatment services to its HIV-positive citizens.

Countries likely will not feel the effects of the financial crisis on HIV/AIDS "in the next six or 12 months because of commitments that have been made in better times," Piot said, adding that he wonders if it will be possible to continue enrolling 700,000 to one million people in drug treatment programs over the next few years. "If not, deaths will go up again, deaths from AIDS, no doubt about it," he said, adding, "We estimate that even if (funding) continues at the same level, deaths will go up to about three million per year by 2011."

Piot also praised the Bush administration and Congress for continuing PEPFAR, which he said is an "unprecedented program that has saved millions of lives." Piot added, "It is quite rare in international development that you can count so easily, you can measure, the impact of actions, and yet this has been the case when it comes to what PEPFAR has done, and it's unprecedented in international development." In addition, Piot commended President Bush and Secretary of State Condoleezza Rice for their comments at the recent White House summit on international development about how the U.S. should not reduce aid. "I hope that the next president will follow along the same lines," Piot said.

Jennifer Kates -- vice president and director of HIV policy at the Kaiser Family Foundation -- said it is difficult to assess how the financial crisis will affect future funding levels. "How the financial crisis plays into that, we still don't know," she said.

Piot will leave his position at UNAIDS at the end of the year to head the new Institute for Global Health at Imperial College London (Vadala, CQ HealthBeat, 10/28).

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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).

Imprisonment of Physicians Who 'Pioneered' Treatment of HIV-Positive Iranians

If Iranian President Mahmoud Ahmadinejad holds a news conference during his visit to the United Nations General Assembly next week, he should be asked why two physicians who started a broad HIV/AIDS awareness campaign in Iran and "pioneered the treatment of Iranian victims of HIV/AIDS" have been imprisoned, Philadelphia Inquirer columnist Trudy Rubin writes in an opinion piece.

According to Rubin, Arash Alaei and his brother, Kamiar -- whom Rubin interviewed in spring 2007 -- started a grass-roots campaign in Iran to treat people living with HIV/AIDS and raise awareness about the epidemic. The brothers were jailed in Iran in late June and, according to Iranian news reports, have been charged with fomenting "a velvet revolution," Rubin writes, adding that the phrase is "shorthand for trying to organize civil society against the regime."

The "irony" of the charges, Rubin writes, is that the brothers were "hoping to increase scientific collaboration with U.S. medical experts in a way that avoids politics." Is "this what scares Iranian officials?" Rubin asks, adding that officials also might fear medical cooperation with the U.S. would threaten the population's fear of a U.S. attack. Ahmadinejad also might be concerned of public unrest before the country's 2009 presidential election, Rubin writes. "[N]one of this explains arresting the doctors Alaei," Rubin writes, concluding it "indicates a government that fears the best and the brightest of its own people" (Rubin, Philadelphia Inquirer, 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

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.

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