Eliminate HIV

‘UNIVERSAL VOLUNTARY HIV TESTING WITH IMMEDIATE ANTIRETROVIRAL THERAPY AS A STRATEGY FOR ELIMINATION OF HIV TRANSMISSION: A MATHEMATICAL MODEL’

In November 2008, an article was published in the renowned medical journal, the Lancet. The article is co-authored by Reuben Granich, Kevin de Cock and Charlie Gilks. The authors of the article are leading members of World Health Organization (WHO) HIV and TB team, but the study is an independent work that has not been endorsed by the WHO. Based on computer modeling, the authors argued that universal HIV testing, followed by the immediate initiation of ART for those who were HIV-positive, could virtually eliminate HIV transmission in the future and reduce the number of people developing AIDS by 95%.

The article aroused heated debate amongst HIV activists, healthcare workers, scientists and officials at organizations like UNAIDS and the World Health Organization (WHO). The debate focused on the human rights implications of the implementation of universal mandatory testing, the potential criminalisation of HIV transmission, and the lack of consideration given to the negative outcomes proven to be associated with universal mandatory HIV testing. However debaters agreed that it is essential that new information that presents the possibility of a solution to HIV epidemic must be seriously considered and researched.

The WHO will hold a consultation in Geneva to discuss the implications of the article. From 28 – 30 April, TAC representatives attended a meeting organized by the AIDS and Rights Alliance of Southern Africa (ARASA) and the Open Society Initiative for Southern Africa (OSISA) in Johannesburg to discuss the article and to formulate a position with other Southern African HIV activists. This position will be presented at the WHO meeting in Geneva. TAC’s briefing on the article is being finalized, and district workshops are planned to discuss the contents of the article and the responses of TAC members to the strategies it proposes. Please click here for TAC’s full brief and response.

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).

Ryan White Funding Delays

Errors in a public notice last week in New Orleans have forced city officials to delay the start of the 2009 process for distributing an expected $5 million in Ryan White Program funding for local HIV/AIDS agencies, the New Orleans Times-Picayune reports. The announcement of the delay comes after Fran Lawless -- who serves as director of Mayor Ray Nagin's Office of Health Care Policy -- in October testified before the city council's Housing and Human Needs Committee that 2008 funding distribution was delayed by six months and that service providers went without funding from March to October.

According to the Times-Picayune, City Council member Arnie Fielkow called on officials to begin the application process for 2009 earlier in the year. In an effort to meet this request, officials listed a public request for proposals in the Times-Picayune on Dec. 8, 9 and 10, which set the deadline for picking up applications as Dec. 5 -- a date that had already past. The deadline for submission also was listed incorrectly in the electronic notice sent directly to the service providers, which left many of them confused, according to the Times-Picayune. Carlos Butler -- Health Policy office manager and the contact who was listed in the public notice -- said that the request for proposals was canceled and referred questions to Lawless and a Nagin spokesperson, who did not respond to requests for comment, the Times-Picayune reports.

Several agencies that receive funding to provide assistance to more than 4,000 people living with HIV/AIDS in the city complained in October that they would be unable to operate if their funding continued to face delays as it had in 2008, according to the Times-Picayune. Doug Morgan, who administers Ryan White Program funding for the federal Health Resources and Service Administration, said, "Our hope is that some of the issues they faced in [2008] will not be repeated in [2009]." He added, "I'm unhappy to learn the initial draft of the (requests for proposal) had glitches in it. It sounds like they're close to repeating some of the timelines they had last year, and that makes me a little nervous."

A new notice appeared Tuesday in the Times-Picayune and the deadline for submitting requests was listed as Jan. 9. The notice also will appear Wednesday and Thursday in the newspaper. Dave Munroe of In This Together -- a not-for-profit agency serving 225 patients that was forced to shut down over the summer because of the delay in funding and reopened in October -- said that the agency will not apply for 2009 funding because of "continuing issues of truthfulness, transparency and professionalism" at the city level (Hammer, New Orleans Times-Picayune, 12/17).

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Increased Diabetes Risk with Antiretrovirals

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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ARV Therapy Should Start Earlier

People living with HIV should begin antiretroviral treatments earlier than what current guidelines recommend, according to a large new study presented on Sunday, the AP/Yahoo! News reports. According to the AP/Yahoo! News, current guidelines by the International AIDS Society-USA and the government recommend that patients who are not showing symptoms of the virus delay treatment until their CD4 T-cell counts drop below 350 per milliliter of blood.

Physicians traditionally have delayed antiretroviral treatment for HIV patients to avoid the treatment's side effects, which can include heart and cholesterol problems, diarrhea, nausea and other conditions. Robert Schooley, infectious disease chief at the University of California-San Diego, said, "There was this thinking, maybe the drugs were worse than the disease. If you could wait as long as you possibly could wait, you would have fewer side effects."

The new study, however, shows that a treatment delay can nearly double the risk of death in the next few years. The study's findings were reported at a conference held by the American Society of Microbiology and the Infectious Diseases Society of America. The National Institute of Allergy and Infectious Diseases helped provide funding for the study (Marchione, AP/Yahoo! News, 10/26).

For the study, researchers led by Mari Kitahata of the University of Washington examined information in the International Epidemiology Databases to Evaluate AIDS, a global network of HIV clinics from 1996 to 2005. Researchers looked at records for 8,374 healthy HIV patients with CD4 counts of 351 to 500 who had never taken highly active antiretroviral treatments. Thirty percent of the patients began antiretroviral treatment, and the remainder delayed treatment until their CD4 counts dropped below 350. The study shows that the patients who delayed treatments were 71% more likely to die during the course of the study period than those who began treatments early (Reuters, 10/26).

Schooley, who helped write the current guidelines for AIDS treatments and acts as a consultant for several companies that make antiretroviral drugs, said the new study and others like it "have all shown the same thing -- that we were starting too late" and need to continue treatments when they have been started. "The data are rather compelling that the risk of death appears to be higher if you wait than if you treat," Anthony Fauci, director of NIAID, said (AP/Yahoo! News, 10/26). He added that treatment guidelines committees are "certainly going to look hard at these data next time they meet" (Sternberg, USA Today, 10/27).

Isentress More Effective in Un-Treated Patients

Merck's antiretroviral drug Isentress suppresses levels of HIV in previously untreated patients better than the company's antiretroviral efavirenz, according to research presented Sunday at a meeting of the American Society of Microbiology and the Infectious Diseases Society of America, Reuters reports. According to Phase III clinical trial results, Isentress -- known generically as raltegravir -- reduced HIV viral loads to undetectable levels in 86% of patients compared with 82% of patients treated with efavirenz (Fox, Reuters, 10/26).

FDA in October 2007 approved raltegravir for use by HIV-positive people who have not responded to other treatments. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA (Kaiser Daily HIV/AIDS Report, 10/15/07). The agency also granted Isentress accelerated approval for use among patients who showed initial signs of resistance to existing antiretrovirals. According to Merck, up to 40% of the approximately 500,000 HIV-positive people in the U.S. receiving antiretrovirals have developed resistance to the drugs. In addition, researchers at the conference said that drug-related adverse effects were significantly fewer in patients treated with Isentress (44%) than with efavirenz (77%) (AFP/Yahoo! News, 10/26).

Robin Isaacs, executive director for infectious disease clinical research at Merck, said, "There was a desperate unmet medical need for those patients who had failed other therapies" until recent years. He added that Isentress and Pfizer's Selzentry -- also approved last year -- helped address that need, along with three other new drugs: Boehringer Ingelheim's Aptivus, and Johnson & Johnson's Prezista and Intelence. According to Isaacs, patients "have all these different options now, which they didn't before, to build new successful regimens."

According to AP/Yahoo! Finance, Pfizer at the conference also presented research from a 48-week study comparing its antiretroviral Selzentry with Bristol-Myer Squibb's antiretroviral Sustiva in a total of 417 patients also receiving GlaxoSmithKline's antiretroviral combination drug Combivir. In both groups, 68% of patients had the HIV virus reduced to undetectable levels; however, 4.2% of those who got Selzentry and 14.2% taking Sustiva stopped because of side effects (Johnson, AP/Yahoo! Finance, 10/26).

Urbanization Among Native Youth Can Increase HIV Rates Amongst the Native Population

Aboriginal youth from northern parts of the Canadian province of British Columbia recently gathered for a three-day conference on HIV/AIDS in an effort to curb the spread of the disease in their communities, the CP/Prince George Citizen reports. Conference attendees, ages 15 to 22, were selected by the First Nations chiefs, councils and health directors.

Emma Palmantier, chair of the Northern B.C. Aboriginal HIV/AIDS Task Force, said that youth attending the conference are expected to take knowledge back to their communities. She added the goal of the training is to give young people basic knowledge about HIV/AIDS, in addition to lessons on sexuality and teen pregnancy, lectures, workshops and group discussions. The CP/Citizen reports that at the end of the conference, the attendees will make recommendations to the task force, chiefs and councils, which will then be used to develop community action plans.

Palmantier said that because many youth who move to urban areas like Prince George and Vancouver come from low-income families, they often turn to commercial sex work and drug trafficking as ways to survive. She said, "The governments need to come up with funds to train these youth in trades and jobs so they can live normal lives. There's a big door of opportunity for training" (Trick, CP/Prince George Citizen, 10/21).

For access to ARV's please visit www.aids-drugs-online.com

Gray's Anatomy helped increase awareness

Many viewers of an episode of ABC's prime-time medical drama "Grey's Anatomy" that included a story about mother-to-child HIV transmission gained awareness of the issue, according to a survey released on Tuesday by the Kaiser Family Foundation, USA Today reports.

For the study, the Foundation worked with writers of the show to embed in the episode the story of an HIV-positive pregnant woman. According to USA Today, the woman is "distraught" before being told by her physician that with proper treatment, her child has a 98% chance of being born HIV-negative. The Foundation conducted three national random surveys of regular viewers of the show one week before, one week after and six weeks after the episode. The surveys combined had 1,505 respondents.

Victoria Rideout, vice president and director of the Foundation's program for the Study of Media and Health, said the goal of the survey was to measure the "impact of the message about mother-to-child HIV transmission" (Marcus, USA Today, 9/17). One week before the show, 15% of the viewers surveyed said that they were aware of the mother-to-child HIV transmission risk. One week after the show, 61% of viewers of the episode were aware of the risk. Six weeks after the show, 45% of viewers remembered the information correctly (Childs, ABC News, 9/17). According to the survey, the increase from 15% to 61% awareness of the risk of mother-to-child HIV transmission translates to more than eight million people learning correct information on the issue from watching the episode. The survey also found that the percentage of viewers who said it was "irresponsible for a woman who knows she is HIV-positive to have a baby" dropped from 61% to 34% after the episode aired, and then increased to 47% six weeks after the show (Kaiser Family Foundation release, 9/16). Rideout said she was "astounded" by the number of viewers who "picked up on factual health info about HIV embedded in the show, and that they remembered it weeks later."

The Foundation and the University of Southern California's Annenberg Norman Lear Center also released a second study of top-10 prime time television shows, finding that six out of 10 episodes from 2004 to 2006 included at least one health-related storyline. "People are very hungry for information about health," Linda Rosenstock, dean of the University of California-Los Angeles School of Public Health, said, adding that entertainment media do "societal good" by putting accurate health information into shows. Jay Bernhardt of CDC said that embedding information accurately into TV content could "help change behaviors about health" (USA Today, 9/17).

Online The studies, and a Kaisernetwork.org webcast of a briefing discussing them, are available online.

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

FDA Gives Tentative Approval to New Generic AIDS Drug

The Food and Drug Administration (FDA) today announced the tentative approval of a generic AIDS drug - abacavir (a-BAK-a-veer) sulfate tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India. Abacavir sulfate tablets are the first generic version of the already approved Ziagen Tablets, an anti-HIV medication manufactured by GlaxoSmithKline. This product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief.

"FDA's action adds yet another anti-HIV product to those available for purchase under the President's Plan and demonstrates our continuing commitment to ensuring that safe, effective, and quality manufactured medications are available for purchase under the President's Plan," said Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Programs.

The President's Emergency Plan for AIDSRelief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. The President's plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. It targets three specific areas related to HIV/AIDS:

Prevention of HIV transmission;
Treatment of AIDS and associated conditions;
Care, including palliative care for HIV infected-individuals, and care for orphans and vulnerable children.
Abacavir is one of the nucleoside reverse transcriptase inhibitors (NRTIs), a class of drugs that helps keep the AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The agency's tentative approval of this product means that Aurobindo's product meets all of FDA's manufacturing quality and clinical safety and efficacy standards. Although existing patents and/or exclusivity prevent its marketing in the United States, the product can be marketed abroad and used under the PEPFAR plan.

More information on HIV and AIDS is available online at FDA's website:http://www.fda.gov/oashi/aids/hiv.html

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).

Drug Access | Boehringer, Gilead Freeze Antiretroviral Prices for Some U.S. Agencies

[Jun 05, 2008]

Pharmaceutical companies Boehringer Ingelheim and Gilead Sciences are freezing the prices of their antiretroviral drugs for select agencies in the U.S., the AIDS Healthcare Foundation announced on Tuesday, Bloomberg reports. Gilead will freeze the prices on its antiretrovirals Viread, Truvada and Emtriva for the U.S. Public Health Service, the Federal Supply Service and state AIDS Drug Assistance Programs, according to company spokesperson Amy Flood. The price freeze will be effective through Dec. 31, 2010, according to AHF. The wholesale acquisition cost is $552 monthly for Viread, $329 monthly for Emtriva and $840 monthly for Truvada, Flood said. She added that government purchasers generally receive partial rebates from the prices. "We share your concern regarding antiretroviral cost pressures faced by government payers, particularly during times of limited budget access and flat funding," Gregg Alton, senior vice president and general counsel at Gilead, said in a letter to AHF.

Boehringer will freeze the price of its antiretroviral Aptivus for ADAPs through May 1, 2009, according to AHF. The price freeze became effective May 1, according to a Boehringer letter to AHF. Boehringer spokesperson Judith von Gordon did not return calls for comment, Bloomberg reports.

"We urge the other drug companies to follow [Boehringer's] and Gilead's lead and to freeze price increases that create an unnecessary burden on an already overburdened public health system and keep lifesaving drugs out of reach for those who need them," AHF President Michael Weinstein said. AHF called on companies to freeze their prices because of issues government agencies have had in increasing access to antiretrovirals (Lauerman, Bloomberg, 6/3). Reponses from Abbott Laboratories, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Pfizer, Roche and Johnson & Johnson subsidiary Tibotec Therapeutics "reiterated the companies' commitment to increasing access but made no specific pledge with regard to" price freezes, according to an AHF release (AHF release, 6/3).

For access to low cost generics, please visit:
www.aids-drugs-online.com

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).