High Arctic STD Rate Raises Fears Of Greater HIV In Far North

January 23, 2008

Toronto - New research suggests that some sexually transmitted diseases are spreading much more quickly in the Arctic than in southern Canada.

The findings raise concerns about both the health effects of the diseases and what their transmission might hint about HIV rates in the North.

“It’s definitely been going up in the North and it’s rather alarming at how fast,” Dionne Gesink Law, a co-author of the paper published in the journal Emerging Infectious Diseases, said Monday.

The paper compared instances of chlamydia and gonorrhea in Canada's three northern territories with southern Canada, Alaska and Greenland between 2003 and 2006.

Canada ranked in the middle in terms of rates of infection, although Gesink Law said that might have been affected by different reporting practices in different countries. The relative openness in talking about sex in Denmark, which controls Greenland, might account for the higher rate of both diseases there, for instance.

But the study also shows that rates of gonorrhea and chlamydia infection are about eight times higher in Canada’s three territories than in its provinces.

And although the rate of gonorrhea infection has decreased slightly in the North, the incidence of chlamydia is growing far faster than in the south. The infection rate increased eight per cent over those years in the provinces and 18 per cent in the territories.

“Our main concern with chlamydia and gonorrhea is that they cause pelvic inflammatory disease and infertility in women,” said Gesink Law, a University of Toronto researcher.

“When you look at who’s actually infected, it’s young people and particularly young women. They’re carrying the burden.”

Those diseases also lead to increased risk of HIV infection, Gesink Law said, and the high rate of transmission suggests that safer sexual practices aren’t being used.

“They obviously have sexual practices that are putting them at risk for (sexually transmitted diseases). If (HIV) was to come into the community it could spread quickly.”

The same sexual precautions, such as the use of a condom, that would protect against gonorrhea would also protect against HIV.

“Four people are known to be living with the virus in Nunavut, said Jeanette Doucet of Pauktuutit, the national Inuit women’s organization. But that number is probably misleading and little is known about the disease’s presence in the Arctic,” she said.

Only pregnant women are tested for sexually transmitted diseases, she said.

“You only know as much as you're testing for,” Doucet said. “It’s possible and even probable that people aren’t being tested. We know that safer sex practices are not happening.”

The social stigma of any kind of sexual disease in small, isolated Arctic communities is a powerful disincentive to get tested, she added.

“The social isolation that would happen for people who test positive is enough to drive them away.”

Gesink Law said the answer could be to help communities develop their own monitoring and education programs for sexually transmitted diseases.

“They will have a much better sense of what’s actually going on and what the factors are that are contributing to the transmissions. It's much more effective if they can work on this together with us, as much as they need us.

“They know what the community will actually listen to.”

Such efforts are already underway in Alaska and Greenland.

A meeting is scheduled in Anchorage next April between officials from Canada and the United States to discuss the issue.

CP, www.365Gay.com

Smitherman Blasts Donor Rules for Gays
“Homosexuals being ghettoized”, he says

January 24, 2008

Canada’s only openly gay provincial health minister yesterday criticized Health Canada for “ghettoizing communities,” arguing that regulations making it difficult for homosexuals to become organ donors should be eased.

Ontario Health Minister George Smitherman’s comments set off a firestorm in Ottawa, with the federal government accusing him of not portraying the reality of the situation.

Following the failings highlighted in Canada's tainted-blood tragedy that left thousands infected with HIV and hepatitis C, Health Canada put in place a series of checks and balances aimed at ensuring all recipients of organ donations were fully aware of the risks involved. This includes telling would-be recipients that if they want to accept an organ from a sexually active gay man, there is a higher risk.

“Surely in this day and age our doctors… are sophisticated enough to judge the risks posed by a prospective donor without resorting to ghettoizing communities,” Mr. Smitherman said in an e-mail exchange yesterday.

“Our drive is to increase donations and save the lives of people languishing on lists. That is my job in part. Why would a regulation be written that ropes off prospective donors?”

But a spokeswoman for federal Health Minister Tony Clement quickly responded, saying the regulation doesn't ban organ donations by sexually active men or other groups considered high-risk. There are exemptions in the policy to allow doctors to conduct transplants even if the donor is in a risk category.

“Health Canada regulations do not prevent gay men from donating organs. The regulations are very clear that the final decision always rests with the recipient patient and the transplant doctor,” Laryssa Waler said yesterday.

“These regulations do not constitute a change in policy. They are formalizing a practice that has been ongoing for many years in Canada that has to do with risk assessment. As Minister of Health for Ontario, George Smitherman is well aware of this,” she added.

Currently, any organ to be donated is subject to tests and screening. But Health Canada says some groups pose a higher risk. That includes men who have had sex with another man even once in the past five years, those with a recent tattoo or piercing and people who have recently been in jail.

Doctors will test these organs for diseases including HIV and hepatitis, as well as speak with the donor's family or friends to assess their behaviour, before a potential recipient authorizes the use of the organs.

Ken Donohue, a spokesman for the British Columbia Transplant Society, said that because of the long waiting list for life-saving transplants, the province will not exclude anyone from being an organ donor.

“It’s not that we say, You fall into this category, you cannot be a donor.” We say, “Okay, in the regulations, Health Canada has said these behaviours are high-risk. Fair enough. But let’s assess the person before simply waving them out of the door,” Mr. Donohue said.

He added: “The regulations essentially put into place certain behaviours which may lead to [being in a] high-risk category. And we need to be extra vigilant in ensuring that organs are safe for transplant. But at the same time, B.C. Transplant has always assessed each potential donor on a case-by-case basis.”

By Caroline Alphonso, The Globe and Mail

Also: Seattle Residents Criticize Exclusive Blood Donor Policies

January 25, 2008

Prospective blood donors are accusing blood banks in the Seattle area of discriminatory regulations that bar most gay and bisexual men from giving blood, the Seattle Post-Intelligencer reported Tuesday.

After the Puget Sound Blood Center announced last week that western Washington’s blood reserves were at emergency levels, some residents voiced frustration at policies that turn away about 6% of those who volunteer to donate blood. About 24,000 people have been placed on the region’s permanent deferral list based on answers to screening questions, according to the center, and men who have had sexual contact with another man since 1977 are automatically rejected.

“It upsets me when I see signs that say ‘We need blood, give now’ but they don’t want my blood,” Pete, a 26-year-old office manager, told the Post-Intelligencer. He was added to the deferral list three years ago for having sex with a man one time.

The Food and Drug Administration drafts the screening questions and requires that blood centers maintain deferral lists. It imposes the restriction to protect the national blood supply from HIV.

Critics argue the policy is flawed.

”Given modern testing and the fact that anyone can be vulnerable to infection, there is no medical or scientific rationale for this discriminatory policy,” Joe Solmonese, president of the Human Rights Campaign, told the Post-Intelligencer.

The Advocate

The Fair Pricing Coalition AIDS Activist Group Reacts to Pricing of AIDS Drugs

January 23, 2008

POZ speaks to pharmaceutical companies and advocates about how the pricing of AIDS meds impacts the community’s ability to access lifesaving treatment

The Fair Pricing Coalition (FPC), a nonprofit advocacy group of leading AIDS activists from across the nation that seeks to ensure fair pricing of HIV drugs, has issued a statement protesting HIV drug price increases announced last week by pharmaceutical company Bristol-Myers Squibb (BMS).

The increases, which range from 6.9 percent to 9 percent on all of BMS’ HIV products, are “well beyond any increases in the Consumer Price Index”—the universal standard for adjusting prices of consumer products based on inflation rates—”and above the increases taken by any other company,” said Martin Delaney of the FPC and Project Inform in the FPC press statement, issued January 14. “These drugs have been on the market for several years, and their development costs have long been recovered. There is no justification for this kind of increase.”

Sonia Choi, a spokesperson for BMS, told POZ that the company’s price hikes were instituted to enable BMS “to continue [its] significant investment in innovative therapies for the HIV community and to allow [it] to invest in all compounds in the BMS pipeline.”

The FPC statement says, however, that BMS, which currently markets five HIV drugs—Zerit, Sustiva, Atripla (produced in conjunction with pharmaceutical company Gilead Sciences), Videx and Reyataz—is doing “very little if any further research in HIV.” FPC member Lynda Dee, of AIDS Action Baltimore, said in the press release, “Considering how little this company has spent developing its portfolio of HIV drugs, especially in recent years, and how well their products are selling, it's unconscionable for BMS to do this. They've got a lot of nerve pushing the limits with these annual price increases.”

Regarding compounds in the BMS pipeline, Choi said, “We have a very strong R&D program in HIV and hepatitis that is focused on addressing the unmet medical needs that still exist in these disease areas. We are developing several innovative HIV therapies with novel mechanisms of action, and we are pursuing multiple targets to develop novel oral compounds for hepatitis C. We also continue to invest in the development of our currently approved medicines through clinical trials [to pursue options like] dosing simplification [like the one-pill, once-daily formulations of Reyataz and Sustiva].”

Choi continued: “Pricing for all Bristol-Myers Squibb medicines are based on the cost to develop, manufacture and bring them to market; their scientific innovation; and the value that they bring to patients and healthcare providers. In HIV, for example, price increases enabled us to invest in efforts to reduce pill burden and simplify therapy for patients. Through this work, we developed one-pill, once-daily formulations of Reyataz and Sustiva, and developed Atripla as a complete HAART regimen with Gilead.”

When asked why BMS raised its prices at this particular moment, Choi told POZ, “We periodically review pricing of our medicines to continue our substantial investment in research to deliver breakthrough therapies for the future.”

The FPC said it would like to see BMS reconsider their price increases. “Our first demand is for [BMS] to roll back the entire price increase, and, if they are unwilling to do that, we’re asking that they at least roll it back to no more than what is warranted by the level of the Consumer Price Index,” said Paul Dalton, director of treatment information and advocacy for Project Inform and a member of the Fair Pricing Coalition, in the January 14 FPC press release.

Founded in 1998, the FPC aims to meet with pharmaceutical companies and help them set drug prices that it considers fair and reasonable for HIV/AIDS and hepatitis treatment. For example, in 2006, after a series of meetings with Tibotec Therapeutics concerning the pricing of one of its new HIV drugs, Prezista, the FPC announced that the company had priced Prezista “responsibly,” calling it a “particularly thoughtful move on the company's part since it recognizes the crisis in funding faced by payers in and out of government.” Dalton told POZ that he believes that setting manageable prices for AIDS medications is essential to ensure that the greatest number of people who need them can afford to buy them. “Drug price plays a big role in deciding which medications to take—both on the part of the prescriber and the patient,” he said to POZ.

According to Dalton, Prezista’s price point allowed the drug to be placed immediately on California’s AIDS Drug Assistance Program (ADAP) formulary list, offering immediate access through ADAP to those who needed the medication. Meanwhile, other higher-priced drugs are not immediately placed on certain ADAP formulary lists, keeping the meds from some members of the HIV community who need them but can’t afford them.

Tibotec announced the launch of another new drug—Intelence—on Friday, January 18. The FPC was also involved in setting the price for Intelence. In a press release issued January 18 by Tibotec Therapeutics, Delaney said: “Tibotec…continues to demonstrate real leadership in the pharmaceutical industry by pricing Intelence fairly and responsibly. We…expect to see the drug quickly accepted on all formularies.” In a press statement issued January 21 by the FPC, Delaney said, “[The pricing of Intelence] shows a real sensitivity to the otherwise growing problem of high drug prices. We’ve been arguing for years that this escalation in drug prices is unjustified and has to stop. The overall cost of health care skyrockets annually and is causing more and more people to go without health insurance. While drug prices are only part of the problem, they are one of the parts we can do something about. We applaud Tibotec for…realizing that fair pricing is also good business.”

In that release, Dee said, “People with resistant virus now have a number of good choices, but for the first time they also have the ability to choose a very good drug that costs less than the alternatives. We hope that the market rewards Tibotec for making this smart strategic move. We hear all the time from drug companies that ‘payers don’t care about drug prices.’ We think that is false and believe that companies that set fair prices will get a larger share of the market. While we are pleased with Tibotec’s price today, we wish it were even lower. We have requested that [Tibotec] make further reductions in the price it charges government payers.” Pam Van Houten, director of communications for Tibotec, told POZ: “We believe Intelence is priced fairly for the value it brings to patients. We are committed to continuing to work with the community on access issues.”

Dalton said to POZ that the potential impact of higher drug prices is higher co-pays for HIV-positive people. “When private insurers look at co-pays for individual drugs, the primary factor in how high that co-pay is going to end up being will be the cost of the drug,” he said, adding, “Drugs that are less expensive tend to have smaller co-pays.” Dalton said that the higher prices could cause a domino effect, influencing other drug companies to raise their prices as well: “The last thing we need right now is a round of excessive price increases for these drugs, which are already extremely expensive and burdening the health care system.”

In addition to asking BMS to scale back its price increases, the activists are recommending that BMS open up its communications with the FPC, the AIDS Treatment Activist Coalition (ATAC), community-based organizations and national and international patient groups to discuss fair pricing of its HIV drugs. “We meet with other companies before any new drug is priced and we talk with them prior to any significant prices increases,” said Delaney in the January 14 FPC release.

The FPC says that BMS has been unwilling to have open discussions with the HIV community—and the FPC members say they are as outraged by BMS’ unwillingness to discuss the pricing of their HIV medicines as they are about the price hikes themselves. According to Choi, however, BMS has “consistently met with the FPC in advance of…product launches,” adding that the company last met with the FPC in June 2006, before the approval of its HIV drug Atripla in July of the same year. She also told POZ that, “BMS hopes to meet with the Fair Pricing Coalition and other community leaders again in the near future to ensure a healthy dialogue and understanding of each other’s perspectives moving forward.”

Choi told POZ, “The HIV advocacy community is an important partner in our efforts to advance HIV patient care. We have worked collaboratively to help meet the needs of patients for the past 15 years, and we are committed to continuing to work closely with our community partners in the future.” She said that BMS is “committed to ensuring that patients who need our medicines are able to access them through the discounts we provide to federal- and state-funded access program, our participation in the pharmaceutical industry's Together RX Access Program, and through the free medicines that we provide via our patient assistance program.”

Said Dalton, “It boils down to ensuring that everyone in the U.S. has access to the drugs they need. If the HIV drugs weren’t as expensive as they are, there never would have been ADAP waiting lists, and people would not be dying from a lack of access to care.”

By Nicole Joseph, www.poz.com

Also: U.S. Patent Office Rejects Patents on Gilead's Antiretroviral Viread

January 24, 2008

The U.S. Patent and Trademark Office on Wednesday rejected four patents on Gilead Sciences' antiretroviral drug Viread, Reuters reports. Viread is known generically as tenofovir and is sold as part of Gilead's combination therapies Truvada and Atripla.

According to Reuters, the not-for-profit group Public Patent Foundation, or PUBPAT, last year submitted evidence to PTO that the scientific knowledge on which the four patents were based existed before Gilead held the patents (Beasley, Reuters, 1/23). The foundation in its challenge to the patents submitted prior knowledge that Gilead had not disclosed to PTO during the patent application process. In its challenge, PUBPAT said that the prior knowledge would have prevented PTO from issuing the patents (PUBPAT release, 1/23).

Gilead has the right to respond to the PTO decision (Reuters, 1/23). The patents will be protected while Gilead responds to the decision, the AP/CNNMoney.com reports (AP/CNNMoney.com, 1/23). Amy Flood, a spokesperson for Gilead, said that rejection is a “typical step in the re-examination process,” adding that although the “process may take some time,” the company does not “believe the exclusivity of our product is in jeopardy” (Reuters, 1/23).

The majority of Gilead's revenue comes from sales of antiretrovirals, the AP/CNNMoney.com reports (AP/CNNMoney.com, 1/23). Morgan Stanley analyst Sapna Srivastava said the rejection creates “some uncertainty about Gilead's core franchise” but added that Morgan Stanley believes the company “will be able to defend its patents.” Srivastava added that it could be three to four years before a final decision regarding the patents is made (Reuters, 1/23).

PUBPAT Executive Director Dan Ravicher said the group is “extremely pleased” with the patent office's decision. Ravicher added that every HIV-positive person is “entitled to the best pharmaceuticals possible without undeserved patents making them exorbitantly expensive” (PUBPAT release, 1/23).

www.kaisernetwork.org

Bush Visits Africa after Urging Congress to Double PEPFAR Money

January 26, 2007

A month after returning from the Middle East, President Bush will travel to Africa in February on a five-country tour.

The president, accompanied by his wife, Laura, will visit Benin, Tanzania, Rwanda, Ghana, and Liberia, the White House announced on Friday.

''This trip will be an opportunity for the president to review firsthand the significant progress since his last visit in 2003 in efforts to increase economic development and fight HIV/AIDS, malaria, and other treatable diseases, as a result of the United States robust programs in these areas,'' a White House statement said.

It said Bush also would talk with leaders about how the United States can help promote democratic reform, respect for human rights, free trade, open investment regimes, and economic opportunity across the continent.

Bush returned January 16 from an eight-day trip to Israel, the Palestinian-governed West Bank, Kuwait, Bahrain, United Arab Emirates, Saudi Arabia, and Egypt. He plans at least a half dozen more trips to the Middle East, Asia, Europe, and South America before leaving office next January.

Bush in November urged Congress to double U.S. money for the global fight against AIDS, to $30 billion over the next five years. In 2003 Congress approved $15 billion for the President's Emergency Plan for AIDS Relief (PEPFAR). The program is active in 120 countries, with a concentrated focus on 15 in sub-Saharan Africa, Asia, and the Caribbean.

As of the end of September, 1.36 million people in those focus countries had received antiretroviral treatment through the program, with a focus on averting infant infections by treating pregnant women. Others receive testing and counseling.

Doubling the funding for PEPFAR would provide treatment for 2.5 million people, the White House said.

Associated Press, Advocate

New Thrift Store in Wilton Manors Funds HIV/AIDS Services
Shop to help support HIV testing, research

January 27, 2008

Seasoned bargain hunters came for the deals: $3.99 cargo shorts, $2.99 T-shirts, $2 pots and pans.

Health advocates came to encourage others to take advantage of free HIV testing.

Gawkers stopped to see what the commotion was about.

After months of anticipation, more than 200 people attended the Saturday morning opening of Florida's first Out of the Closet, a national thrift store chain operated by the AIDS Healthcare Foundation that benefits HIV/AIDS medical care and research.

As dozens of pink and teal balloons drifted in the air and Diana Ross' I'm Coming Out blasted from giant speakers, shoppers poured into the new shop at 2097 Wilton Drive.

”This is so neat,” said Dell Wright, 62, of Fort Lauderdale, who carried a basket filled with T-shirts to buy. “And it's so good to know that this is going to help so many people with AIDS.”

Out of the Closet began 18 years ago in Los Angeles and has grown into a chain of 18 stores around the country, according to Michael Weinstein, president of the AIDS Healthcare Foundation. Proceeds from the Wilton Manors shop, which includes a pharmacy, will help support free HIV testing, public awareness campaigns and regular condom distribution, Weinstein said.

The foundation also plans to open a full-service clinic in North Miami in the coming year, he said.

”South Florida really has one of the nation's largest hot spots of AIDS, but you wouldn't know that's the situation here,” Weinstein said. “It's kind of treated as a dirty little secret.”

An estimated 17,053 adults and children in Broward County were living with AIDS as of last August, according to the county Department of Health.

Jeff Mintzer 47, of Pembroke Park, attended Saturday's opening to transfer his prescription for two HIV medications to the store's new pharmacy. Doing so renewed his optimism, he said, since he had to stop buying the medicine a month and a half ago because it was too expensive.

”It feels good,” Mintzer said after learning he might qualify for discounted prescriptions. “Even though I have insurance, it's still a lot of money.”

The opening of the national thrift store outlet and pharmacy comes two months after the Poverello Center, a long-standing Wilton Manors thrift shop, announced it would not accept new clients for its free food bank for at least three months because of funding cuts from Broward County's HIV Health Services Planning Council.

Despite those financial struggles, Thomas Smith, Poverello's chief financial officer, said he welcomes the opening of Out of the Closet.

”Competition is good for anyone,” Smith said. “I don't think it's going to hurt anyone. Any time you have more thrift stores, more people come into the area to go shopping.”

By Elizabeth Baier, South Florida Sun-Sentinel

California Court: Medical Pot Not OK at Work

January 26, 2008

San Francisco - Employers can fire workers who use medical marijuana even if it was legally recommended by a doctor, the California Supreme Court ruled this week, dealing the state another setback in its standoff with federal law enforcement.

Marijuana is considered beneficial for treating some forms of cancer, glaucoma, multiple sclerosis, epilepsy and HIV-AIDS.

The high court upheld a small Sacramento telecommunications company's firing of a man who flunked a company-ordered drug test. Gary Ross held a medical marijuana card authorizing him to use the drug to treat a back injury sustained while serving in the Air Force.

The company, Ragingwire Inc., argued that it rightfully fired Ross because all marijuana use is illegal under federal law, which does not recognize the medical marijuana laws in California and 11 other states.

The justices upheld that argument in a 5-2 decision.

”No state law could completely legalize marijuana for medical purposes because the drug remains illegal under federal law,” Justice Kathryn Werdegar wrote for the majority.

The U.S. Supreme Court declared in 2005 that state medicinal marijuana laws don't protect users from prosecution. The Drug Enforcement Administration and other federal agencies have been actively shutting down major medical marijuana dispensaries throughout California over the last two years and charging their operators with felony distribution charges.

Ragingwire said it fired Ross because it feared it could be the target of a federal raid, among other reasons.

The Santa Clara Valley Transportation Authority and the Western Electrical Contractors Association Inc. had joined Ragingwire's case, arguing that companies could lose federal contracts and grants if they allowed employees to smoke pot.

The conservative nonprofit Pacific Legal Foundation said in a friend-of-the-court filing that employers could also be liable for damage done by high workers.

Ross had argued that medical marijuana users should receive the same workplace protection from discipline that employees with valid painkiller prescriptions do. California voters legalized medicinal marijuana in 1996.

The nonprofit marijuana advocacy group Americans for Safe Access, which represents Ross, estimates that 300,000 Americans use medical marijuana. The Oakland-based group said it has received hundreds of employee discrimination complaints in California since it began tracking the issue in 2005.

Safe Access attorney Joe Elford said the group will now focus on urging the Legislature to pass a law protecting workers who use medical marijuana.

”We remain confident that there will be a day when medical marijuana patients are not discriminated against in the workplace,” he said.

Assemblyman Mark Leno, a Democrat who represents part of San Francisco, said he will introduce legislation addressing those concerns in the next few weeks.

The ruling “strikes a serious blow to patients' rights,” he said.

Eleven states have adopted medical-marijuana laws similar to California's: Alaska, Colorado, Hawaii, Maine, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont and Washington.

The American Medical Association advocates keeping marijuana classified as a tightly controlled and dangerous drug that should not be legalized until more research is done.

By The Associated Press, www.365Gay.com

The Global Fund to Fight AIDS, TB and Malaria Launches Corporate Champions Program
Inaugural Partner Chevron to Commit $30 Million

January 21, 2008

Geneva, Switzerland & San Ramon, Calif - The Global Fund to Fight AIDS, TB and malaria today announced the launch of The Global Fund Corporate Champions program, an innovative way for multinational corporations to significantly invest in the fight against the three diseases.

Chevron Corporation (NYSE:CVX) is the program’s inaugural Corporate Champion, making a commitment to invest US$30 million over three years in Global Fund-supported programs in parts of Asia and Africa.

The Global Fund Corporate Champions program has been designed as an integrated platform for public private partnership, giving companies the opportunity to make a substantial commitment to global health. Each Corporate Champion will make a financial contribution to Global Fund-supported programs in countries where it operates, thereby significantly expanding upon its own workplace and community projects and investing in high-quality, rigorously monitored and results-focused, health programs aligned with national needs and strategies.

In addition, Corporate Champions will leverage their people and assets to improve the effectiveness and reach of health programs. Companies can achieve this by lending their management skills and business infrastructure to the development and implementation of national strategies in the fight against AIDS, TB and malaria. Corporate Champions also are required to demonstrate a long-term commitment to fighting these global health issues. Chevron was selected as the inaugural partner as a result of its highly successful community engagement programs tackling AIDS and malaria and its award-winning HIV/AIDS workplace programs.

”Global companies with large, long-term investments in developing countries understand that fighting disease is a necessary part of their strategic investments,” said Rajat Gupta, chairman of the Board of Directors for The Global Fund. “The Global Fund Corporate Champion program provides the opportunity for these companies to make significant, effective, results-driven investments in national health programs. We are extremely pleased with the commitment from Chevron. Its long-standing dedication to combating HIV/AIDS combined with its needs-based partnership approach to community engagement makes Chevron an ideal first Corporate Champion.”

”AIDS, TB and malaria are critical health threats in many of the communities where we operate around the world,” said Dave O’Reilly, Chevron chairman and CEO. “The key to the success of The Global Fund has been the strength of its partnership and collaboration model, which is an approach that Chevron shares. For a company such as ours, it makes clear business sense to join with The Global Fund and leverage resources in the fight against these diseases.”

”Chevron’s strategic investment in The Global Fund sets a standard others should aspire to,” said Ambassador Richard Holbrooke, Global Business Coalition’s president and CEO. “This exceptional new commitment to global health supplements Chevron’s ongoing programming on HIV, TB and malaria, which is already recognized as best in class. The Chevron-Global Fund partnership will enhance-already strong programs in hard-hit regions, strengthen local communities and bring Chevron’s business skills and human resources to bear on some of the most daunting challenges of our time.”

Since its creation in 2002, The Global Fund has become the dominant multilateral financer of programs to fight AIDS, TB and malaria, providing well over 20 percent of all international finance against AIDS and two-thirds of global financing for TB and malaria. So far, programs supported by The Global Fund have averted 2 million deaths by providing AIDS treatment for 1.4 million people and TB treatment for 3.3 million people, and by distributing 46 million insecticide-treated bed nets that help prevent the spread of malaria.

The Global Fund is a unique public/private partnership dedicated to attracting and disbursing additional resources to prevent and treat HIV and AIDS, tuberculosis and malaria. This partnership between governments, non governmental organizations, the private sector, and affected communities represents a new approach to international health financing. The Global Fund works in close collaboration with other bilateral and multilateral organizations to supplement existing efforts dealing with the three diseases.

Chevron is one of the world’s leading integrated energy companies. We have approximately 58,000 employees, and operate across the entire energy spectrum — producing and transporting crude oil and natural gas; refining, marketing and distributing fuels and other energy products and services; manufacturing and selling petrochemical products; generating power; and developing and commercializing the energy resources of the future, including biofuels and other renewables. Chevron is based in San Ramon, Calif. More information on Chevron is available at www.chevron.com.

Business Wire

HIV-Positive Prison Inmates in Russia Have Limited Access to Antiretroviral Treatment, Advocates Say

January 25, 2008

Prison inmates living with HIV/AIDS in Russia often lack access to proper antiretroviral treatment and medical care, some advocates said recently, the Moscow Times reports. Limited education among inmates about the disease, a shortage of doctors and bureaucratic barriers in obtaining medical release in the country are contributing to the problem, the Times reports. According to Alexander Kononets, head of the Federal Prison Service's health department, there are 42,000 inmates living with HIV/AIDS in Russian prisons and jails. Written consent is required for an HIV-positive inmate to receive treatment while incarcerated, according to the Times.

Federal Prison Service spokesperson Valery Zaitsev said inmates are screened for HIV/AIDS when they enter a detention facility and usually are screened again when they are transferred to prison. The tests usually are the first time the inmates are tested for the virus, Zaitsev said, adding that those who test HIV-positive subsequently “receive antiretroviral drugs and other appropriate treatment.” However, Yelena Panasenko, who coordinates support groups for prisoners with HIV/AIDS in the country's Saratov region, said additional efforts are needed to help the inmates maintain treatment. “Prison doctors can offer treatment, but they will not persuade each inmate to undergo it,” Panasenko said.

Tatyana Bakulina -- head of IMENA, a St. Petersburg-based nongovernmental organization that operates support programs for HIV-positive inmates -- added that the situation for inmates living with HIV/AIDS is exacerbated by high rates of tuberculosis and hepatitis C coinfection. Kononets said that there are 43,000 inmates with TB in Russia. “Sometimes a prisoner will come down with a severe fever for three days, and nobody will examine him or give him any medicine,” Bakulina said.

Vadim Pokrovsky, head of the Federal AIDS Center, said that the situation concerning medical treatment for inmates “was pretty poor last year, but it is already getting better.” According to Pokrovsky, inmates now receive treatment under a federal program instead of through regional governments. Experts also said that difficulties released prisoners face reintegrating into society can complicate treatment. About 230,000 convicts are released annually -- 90% of whom suffer from various diseases -- Kononets told the Public Chamber in October 2007.

Court Case

The Supreme Court on Tuesday rejected a request by Vasily Aleksanyan, a former executive of Russia's Yukos Oil Company, to be released from prison so he could be treated for HIV/AIDS, the Times reports. Aleksanyan, who is facing embezzlement and tax evasion charges, claims that he was intentionally denied treatment while in jail as punishment for not testifying against his bosses. Russian law says that any person diagnosed with serious illness should not be kept in pretrial detention. Prosecutors said that Aleksanyan refused treatment while in jail; however, his lawyer, Yelena Lvova, says Aleksanyan gave written consent for therapy in July 2007. Aleksanyan never received treatment and has not had a medical examination since Dec. 30, 2007, Lvova said. Aleksanyan was diagnosed with HIV a few months after his detention in April 2006 and “could die any day,” another lawyer said (Osadchuk, Moscow Times, 1/24).

www.kaisernetwork.org

Experts Working On Vaccine To Fight AIDS In China

January 21, 2008

Hong Kong - Scientists in Hong Kong and China are working on an AIDS vaccine to protect against three variants of HIV sweeping across south and west China, Hong Kong and Taiwan.

Chen Zhiwei, director of the new AIDS Institute in Hong Kong, said scientists have been using gene sequencing to track how HIV viruses in China are evolving, and their geographical spread.

Two closely-related HIV variants had spread through intravenous drug users (IDUs) from southwestern Yunnan province; one to as far as Xinjiang in the northwest, and the second to Guangdong in the south.

The third variant is in Yunnan and southern Guangxi province, which Chen said is passed mainly through heterosexual sex.

Chen, who worked alongside famous HIV/AIDS scientist David Ho in the U.S. before heading the Hong Kong institute, said collaborating scientists in the U.S. and China have designed a vaccine based on the two HIV variants spreading among IDUs and they hope to test it in animals by the end of this year.

”If you want to make a vaccine, it is better to have a local strain as a target to work on,” Chen said in an interview with Reuters.

Asked if the experimental vaccine may confer protection against the third variant that is transmitted chiefly through sex, Chen said: “That's what we want to know. There is about 60-70 percent identity between the subtypes. If viruses are very closely related, chances of cross protection are better.”

The HIV variants circulating in south and west China are very similar to those found in Myanmar, Vietnam, Cambodia, Thailand and India, as well as in Taiwan and Hong Kong, he said.

”The epidemic in China has evolved over time. Previously, the major risk factors were IDUs and the tragic story of blood donation in central China. But after these people got infected, they passed it to their spouses, friends and these are in the general population,” Chen said.

”After 2006, heterosexual sex has been playing the major role in transmission of the virus. Infections have gone up in the general population and from mother to child.”

The presence of these variants in Taiwan and Hong Kong also could be a tell-tale sign of the travelling routes of drug users in the region, Chen said.

Blood Donations

The AIDS Institute hopes to help set up HIV screening centres in China, which is estimated to have about 700,000 people living with HIV/AIDS, up from an earlier estimate of 650,000.

Chen also spoke about hundreds of thousands of HIV/AIDS patients in central China, who contracted the virus in the 1990s from unsanitary blood donations.

Despite free antiretroviral drugs provided by the government, some 30 percent of these patients have developed full-blown AIDS - which Chen attributed to drug resistance.

Antiretroviral drugs help keep the HIV virus in check and can prevent the progression to AIDS. But regimens can be complicated and sufferers can easily develop drug resistance if they miss doses - meaning they will then have to resort to stronger, more expensive, and in China, often unavailable drugs.

By Tan Ee Lyn, Editing by Sanjeev Miglani, Reuters

One Strain Behind Epidemic of Staph Infections

January 21, 2008

A single strain of an evolving bacterium has been responsible for most of the community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infections that have spread rapidly in the United States during the past five years, a new government study finds.

Typically, CA-MRSA causes boils, but it can lead to life-threatening conditions that are difficult to treat, according to the study.

The National Institute of Allergy and Infectious Diseases (NIAID) researchers said their findings resolve debate about the molecular evolution of CA-MRSA in the United States and rule out the possibility that multiple strains of USA300 emerged randomly with similar characteristics.

This single strain of USA300, which has spread with “extraordinary transmissibility” in the past five years, was identified by analyzing the genomes of USA300 collected from 10 patients infected in different parts of the United States between 2002 and 2005. Eight of the 10 samples had almost identical genomes, indicating they were from a common strain. The remaining two were related to the other eight, but more distantly.

The researchers also found that two of the eight almost identical USA300 samples caused far fewer deaths in laboratory mice than the other samples. This appears to support an emerging belief that tiny genetic changes among evolving strains have a major impact on disease severity and the potential for development of drug resistance.

The study was published in this week's online issue of the Proceedings of the National Academy of Sciences.

”The USA300 group of strains appears to have extraordinary transmissibility and fitness,” research leader Frank R. DeLeo said in a prepared statement. “We anticipate that new USA300 derivatives will emerge within the next several years and that these strains will have a wide range of disease-causing potential.”

It's hoped this research will lead to new test that can quickly identify specific MRSA strains.

A second study, led by the same NIAID scientists, discovered new information about how MRSA bacteria -- including the USA300 group -- avoid destruction by the human immune system's white blood cells. The study found that MRSA senses danger and turns the tables, killing the white blood cells.

That study was recently published online in The Journal of Immunology.

”Scientists are pressing ahead quickly to learn more about how some MRSA strains evade the immune system and spread quickly. The information presented in these two studies adds important new insights into that expanding knowledge base,” NIAID Director Dr. Anthony S. Fauci said in a prepared statement.

More information:
The U.S. Centers for Disease Control and Prevention has more about MRSA.

SOURCE: National Institute of Allergy and Infectious Diseases, news release, Jan. 21, 2008

Health Day

Tibotec’s Intelence (Etravirine, TMC125) is Approved by FDA

January 18, 2008

The U.S. Food and Drug Administration (FDA) announced today that it has granted approval to Tibotec’s Intelence (etravirine), the first new non-nucleoside reverse transcriptase inhibitor (NNRTI) in ten years. Intelence, at a dose of 200 mg twice a day, has been approved specifically for treatment-experienced HIV-positive patients with resistance to older NNRTIs and other ARVs.

The approval of Intelence is based on data from two clinical trials involving 1,200 highly treatment experienced HIV-positive adults. Intelence, when combined with other approved ARVs, reduced viral loads to undetectable in up to 60 percent of the patients who received the drug for 24 weeks, compared to 40 percent of those who received a placebo plus other HIV drugs. CD4 counts were also higher among those receiving Intelence, compared with those receiving placebo.

The side effects most commonly reported among study volunteers who received Intelence were rash and nausea.

Intelence works by blocking HIV’s reverse transcriptase enzyme. After HIV's genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. NNRTIs stop this process and prevent HIV from infecting the CD4 cell and producing new virus particles.

A key advantage of Intelence is its resistance profile. Compared with older NNRTIs—efavirenz (found in Sustiva/Stocrin and Atripla), nevirapine (Viramune) and delavirdine (Rescriptor)—test tube studies suggest that multiple mutations in HIV’s reverse transcriptase enzyme are needed to weaken the drug’s effectiveness; only one mutation is needed to confer high-level resistance to efavirenz, nevirapine and delavirdine. What’s more, Intelence is active against HIV strains containing two key mutations that cause resistance to older NNRTIs—K103N and Y181C—making it the first NNRTI to offer potential benefits to patients who have virus that is no longer sensitive to efavirenz, nevirapine and delavirdine.

The correct Intelence dose for treatment-experienced patients is two 100 mg tablets, taken twice a day with food.

Until more complete drug interaction studies are conducted, Intelence should not be combined with many antiretrovirals, including Norvir (ritonavir)-boosted Aptivus (tipranavir), Lexiva (fosamprenavir) or Reyataz (atazanavir); full-dose Norvir; protease inhibitors given without a Norvir booster; and other NNRTIs. Intelence should be used cautiously with Kaletra (lopinavir/ritonavir).

Other drugs Intelence should not be used with include the anticonvulsants Tegretol (carbamezepine), Luminal (Phenobarbital) and Dilantin (phenytoin); the antibiotics Rifadin (rifampin), Priftin (rifapentine) and Mycobutin (rifabutin); or products containing St. John’s wort (Hypericum perforatum).

The safety and effectiveness of Intelence in first-time treatment takers has not yet been established. A clinical trial evaluating the benefits of Intelence, as a first-line NNRTI option, is currently under way.

For a more detailed review of the effectiveness of Intelence for the treatment of NNRTI-resistant HIV, check out our recent special report, “Etravirine—Countdown to Launch.”

www.aidsmeds.com/articles/etravirine_tmc125_hiv_2042_13846.shtml

www.aidsmeds.com

Also: HIV Patients Get New Drug In Battle To Keep Aids At Bay

January 28, 2008

London - A new class of drug for people with HIV is being introduced in Britain today, having been described by researchers as a huge step forward in treating the deadly infection.

Raltegravir, available as tablets to be taken twice a day, is approved for use with other antiretroviral drugs to treat HIV in about one in ten patients whose therapy has stopped working. Because of their potential to prolong life by decades, HIV drugs are considered cost-effective and raltegravir is likely to be available on the NHS for all infected patients.

Doctors believe that the drug could become standard treatment, potentially preventing HIV progressing into full-blown Aids. Three quarters of trial patients showed a significant reduction in viral load – the prevalance of the virus in their bloodstream – compared with 40 per cent taking current medication alone. Some patients had a marked improvement to the point where levels of the virus were “undetectable”, doctors said.

An estimated 73,000 people in Britain are infected with HIV, or human immunodeficiency virus, which culminates in Aids (acquired immunodeficiency syndrome). Although HIV infection is still considered serious, early diagnosis and appropriate treatment can allow for a relatively normal lifespan.

HIV continually changes and can become resistant to treatment, leading to a continuing search for new drugs. Raltegravir is the first in a new class of HIV treatments called integrase inhibitors, which it is hoped will avoid the risks of heart attack and cancer associated with existing medication. It works by blocking integrase, an enzyme that HIV relies on to replicate itself. It affects the ability of the virus to infect other cells, thus reducing the blood’s viral load.

During the trials, patients were given raltegravir or the dummy drug plus optimised background therapy (OBT), a regime of antiretroviral drugs tailored to individual patients.

One study published in The Lancet in April last year was based on 178 patients with advanced HIV. They had been taking regular antiretroviral drugs for about ten years but were not responding to them. Patients taking raltegravir had an average of a 98 per cent drop in their HIV ribonucleic acid (RNA) count, compared with 45 per cent in the dummy group. The number of CD4 cells, an indicator of the immune system’s ability to fight disease, was also boosted.

Made by the US-based company Merck, the drug is also known by the brand name Isentress. Mark Nelson, director of HIV services at the Chelsea and Westminster Hospital, London, said that it had already provided a life-line to 30 of his patients. “While this is not a ‘cure’ for HIV it does mean we can suppress the virus to where it is virtually undetectable.”

Dr Nelson added that the drug’s long-term safety record would be very important, given that more adverse effects from existing treatments were emerging after many years of therapy.

”Raltegravir is going to be popular because it’s very effective and it seems to have a good safety profile,” he said. “Previous drugs have done a terrific job keeping people alive. But now we have to start thinking about safety.”

Eight years and four different drug cocktails after Philippe B, 41, learnt that he had HIV, he almost gave up.

”Ten years ago nobody told you anything about the drugs or how to take them, so I stopped for a few months. I became resistant and had to change my combination. Every new combination meant new side effects – nausea, diarrhoea. Sometimes the fatigue was so bad, I couldn’t get out of bed.”

Philippe, who works for the Terence Higgins Trust, had a viral load of 500,000 (more than 100,000 is considered high) and was in hospital with toxoplasmosis, ulcers and paralysis. After three months, he started a new regime that was the first to work – his viral load is below 50.

Philippe says that he is lucky because he has yet to run out of drug options. “It’s very important that there are new drugs. HIV is not a death sentence any more but there’s still no cure. After you become resistant, you start running out of options.”

By David Rose, www.timesonline.co.uk

Kaletra Monotherapy Disappoints

January 18, 2008

Contrary to the encouraging findings of several small studies, newly reported data conclude that Kaletra (lopinavir/ritonavir) monotherapy is not a durable treatment option for HIV-positive people. Compared with patients who took Kaletra plus Retrovir (zidovudine) and Epivir (lamivudine), study volunteers who used Kaletra without other antiretrovirals were less likely to have undetectable viral loads after 48 weeks. Final data from the MONARK study were published in the February 1 issue of AIDS.

Researchers began studying Kaletra monotherapy several years ago in the hopes that taking only a protease inhibitor (PI) would be as effective at controlling HIV as a standard triple-drug regimen, but without the side effects of the two extra drugs. Small studies unveiled over the last few years have hinted that this may be true, and the use of a Norvir (ritonavir)-boosted PI like Kaletra as monotherapy has gained in popularity among European physicians.

For the MONARK study, Jean-Francois Delfraissy from the department of internal medicine and infectious diseases at Bicetre University Hospital in Le Kremlin-Bicetre, France, and his colleagues enrolled 136 HIV-positive patients who were relatively new to antiretroviral therapy. Eighty-three patients were randomized to receive Kaletra monotherapy and 53 patients received Kaletra plus Retrovir and Epivir.

After 48 weeks of treatment, 64 percent of those in the monotherapy group, compared with 75 percent of those in the combination therapy group, had viral loads of less than 50 copies, according to a strict “intent-to-treat” statistical analysis of the data. Though monotherapy appeared inferior, the difference between the two groups was small enough that it could have occurred by chance.

Differences between the groups became significant when the researchers used a more liberal “as-treated” statistical analysis. Comparing only those who remained on their assigned regimens for 48 weeks, 98 percent of people on the triple combination arm had viral loads below 50, compared with just 80 percent of those on Kaletra monotherapy. Moreover, three people in the monotherapy group who failed treatment developed protease resistance mutations compared with none of those on the three-drug regimen.

Though the proportion of people who experienced a serious side effect was statistically equivalent, more people,12 percent, in the monotherapy group experienced a serious side effect, compared with eight percent of patients in the triple-drug regimen group. This was contrary to expectations.

Delfraissy’s team concluded that Kaletra monotherapy cannot be recommended as a first-line therapeutic strategy.

www.aidsmeds.com

Factors Affecting HIV Therapy Choice in Women Have Changed

January 23, 2008

The first decade of effective anti-HIV therapy has seen the main predictors of regimen choice among HIV-positive women switch from biological to socio-demographic factors, according to a report in the January 15th edition of Clinical Infectious Diseases. The results come from a wide-ranging study that investigated the patterns of antiretroviral therapy, from initial regimen choice to predictors of switching, among a cohort of HIV-positive women in the US.

While knowledge of the specific issues faced by women with HIV grows, there is a paucity of data concerning antiretroviral therapy in this group. To explore how anti-HIV therapy might be different in women, Golub and colleagues at several American universities tapped into the extensive records of the Women’s Interagency HIV Study (WIHS) to determine patterns of initial regimen choice and switches in regimens, as well as to identify their predictors.

WIHS, established in 1993, is a prospective, multicentre, cohort study of over 2700 HIV-positive women in the US. Researchers study data for almost ten years, which they then divided into three periods: 1996 to 2000, 2000 to 2002 and 2002 to 2005.

The records of 1555 women starting antiretroviral therapy during these periods were studied for initial regimen type (protease inhibitor [PI] based, non-nucleoside reverse transcriptase inhibitor [NNRTI] based or triple nucleoside reverse transcriptase inhibitor [NRTI]), any switches from their initial program and immunological follow-up at years one and two. Switches in regimen were recorded only when an entire drug class was switched, not a drug from one class was switched for a drug of the same class.

Patterns Of Initial Regimen Choice

At study start, in July 1996, almost all women began treatment with a PI-based regimen. By March 2000, less than 40% of women started a PI regimen, with NNRTI-based regimens being a more popular choice and triple-NRTI regimens comprising less than 10% of new regimens.

In the second period, from 2000 to 2002, there were no significant changes in the type of regimen started.

In the final period, there was a sharp, but brief increase in the proportion of women starting triple-NRTI regimens. This proportion quickly dwindled so that by the end of the study period, March 2005, women starting antiretroviral therapy were almost equally divided between the PI and NNRTI groups.

Predictors of Initial Regimen Choice

The researchers observed that predictors of regimen type also changed during these periods. From 1996 to 2000, women with a CD4 cell count above 200 cells/mm3 were more than twice as likely to start an NNRTI regimen than a PI regimen compared with women with a lower CD4 cell count. As well, injection drug use was associated with a lower chance of starting an NNRTI regimen.

From 2000 to 2002, biological predictors continued to predominate, with starting an NNRTI regimen associated with lower CD4 cells counts (under 500 cells/mm3) and higher peak viral loads compared with PI regimen starters. Preference for a Spanish-language interview was also associated with NNRTI regimen choice.

In the final period, from 2002 to 2005, socio-demographic factors predominated in choice of initial regimen. Of note, Black and Latina women were more likely to initiate a PI regimen than an NNRTI regimen. They were also more likely to initiate a triple-NRTI regimen than an NNRTI regimen.

Patterns In Regimen Switching

The researchers included 301 women in their analysis of regimen switching. About half of the group, 157 women, started with an NNRTI regimen, while 93 started a PI regimen. The cumulative hazard of switching by 12 months was 50%, and was 62% by 24 months. Compared with those starting a PI regimen, women who started an NNRTI regimen were slightly, but not significantly less likely to switch, while women starting a triple-NRTI regimen were significantly more likely to switch.

Women who switched were more likely to have started with an NNRTI regimen, be African American and to have already been on antiretroviral therapy. Many expected factors were independently associated with regimen switching, including clinical AIDS after starting treatment, already having taken antiretrovirals, higher viral load, frequent recent visits with a physician and history of seeking mental health treatment.

Impact On Immunological Response

When researchers evaluated changes in CD4 cell counts, they performed analyses incorporating the identified predictors. In women starting a triple-NRTI regimen had on average a CD4 cell count 90 cells lower after a year of treatment than women starting a PI regimen, after adjusting for potentially confounding factors. There was no different between women starting PI and NNRTI regimens. However at two years, women starting an NNRTI regimen also had a CD4 cell count lower than PI-regimen women, on average 54 cells/mm3 lower.

In discussing their findings, the researchers note that regimen choice and predictors have changed over time. They argue that including these predictors in the analysis of CD4 cell count data allowed them to identify a significant association between initial regimen choice and subsequent immunological response.

”It is clear,” they write, “that a multitude of factors affect a patient’s initial regimen, and we conclude that omitting those from investigations into the effectiveness of therapy has the potential to introduce residual confounding. In this cohort of US women, we were able to avoid such confounding by identifying, and subsequently controlling for, predictors of initial HAART regimen.” In conclusion, they urge future groups to include predictors in the design of future studies assessing the efficacy of HIV therapies in observational settings such as WIHS.

Reference

Golub ET et al. Patterns, predictors, and consequences of initial regimen type among HIV-infected women receiving highly active antiretroviral therapy. Clin Infect Dis 46: 305 – 312, 2008.

By David McLay, www.aidsmap.com

Antiretrovirals Significantly Increase Survival in HIV-Positive Children

January 23, 2008

HIV-positive children treated with a triple-combination antiretroviral regimen have a significant survival advantage, compared with children receiving less effective drug regimens or no antiretrovirals, according to the authors of a new study published in the February 15 issue of Clinical Infectious Diseases.

These results, while perhaps not unexpected, are important because unlike with adults, there have been very few large, well-controlled studies measuring the impact of combination antiretroviral therapy in HIV-positive children.

Kunjal Patel, PhD, of the department of epidemiology at Harvard School of Public Health in Cambridge, Massachusetts, and her colleagues evaluated the medical files of 1,236 HIV-positive children enrolled in two Pediatric AIDS Clinical Trials Group (PACTG) studies, PACTG 219 and PACTG 219C. All of the children were infected with HIV before or during birth. At baseline—the first study visit—80 percent of the children were at least 4 years old. Roughly half were female, 56 percent were black and 28 percent entered the study with an AIDS diagnosis.

During the course of the study, 70 percent of the children began a triple-combination antiretroviral regimen that included at least two different classes of drugs. The majority were given a regimen including a protease inhibitor (PI) plus two nucleoside reverse transcriptase inhibitors (NRTI).

Over the ten years of the study, five percent of the children who received triple combination therapy died, compared with ten percent of the children who either started a less effective antiretroviral regimen or who did not take antiretrovirals at all.

When Patel’s team accounted for a variety of factors, including age and immune status, they found that the children who initiated combination therapy were 76 percent less likely to die than children who did not initiate combination therapy.

The authors write that this study offers strong proof of the effectiveness of combination antiretroviral therapy in children. They did not, however, publish information on side effects experienced by the children in the study.

www.poz.com

Less Risk Of AIDS For Patients With Low CD4 Cell Count and No Treatment Options Who Stay On Failing Therapy

January 25, 2008

HIV-positive patients with a low CD4 cell count and no new treatment options who are taking antiretroviral therapy which is not controlling their viral load should remain on their therapy rather than interrupt treatment, French researchers report in the January 15th edition of Clinical Infectious Diseases.

Patients who interrupted treatment were much more likely to experience disease progression and develop new AIDS-defining illnesses than patients who stayed on their virologically-failing regimen, the French researchers found.

Potent anti-HIV therapy significantly reduces the risk of HIV disease progression by suppressing HIV replication and allowing the recovery of the immune system. A detectable viral load during antiretroviral therapy can lead to the development of drug-resistant strains of HIV.

Two treatment strategies are often advocated for patients who have extensive experience of anti-HIV treatment, limited new drug options and ongoing replication of drug-resistant HIV: either maintain the existing treatment, often with additional “re-cycled” drugs; or, temporarily interrupt HIV treatment, hopefully allowing drug-sensitive HIV to once again emerge.

There are conflicting results from studies looking at both treatment strategies.

But no study has looked at HIV disease progression in extensively-treated patients who remain on a virologically failing treatment compared to such patients who interrupt treatment. It is therefore unknown if treatment interruption because of virologically failing treatment in patients with a low CD4 cell count – below 200 cells/mm3 - is a safe strategy.

Investigators therefore analysed data from the French HIV hospital database. They identified patients enrolled between 2000 – 2005 who had a CD4 cell count below 200 cells/mm3 and who had taken one or more antiretroviral regimens for six or months.

These patients were divided into three groups: patients who interrupted treatment; those who remained on treatment despite having a viral load above 500 copies/ml; and those who took anti-HIV treatment and maintained an undetectable viral load.

Information was gathered on the development of AIDS-defining illnesses in each of the three groups of patients.

A total of 12,765 patients were included in the investigators’ analysis, and 72% of these patients were men.

Anti-HIV therapy was interrupted by 2,399 patients and 39% of these had a viral load above 30,000 copies/ml. The number of patients who stayed on anti-HIV therapy with a detectable viral load was 8,783 and 46% of these patients had a viral load above 30,000 copies/ml. Overall, 4,351 patients who took anti-HIV treatment and had an undetectable viral load.

A new AIDS-defining illness was recorded in 348 patients in the treatment interruption arm, with an incidence of 18.5 cases per 100 patient years of follow-up. Of these, 99 (29%) occurred in the first month after treatment was stopped.

New AIDS events were recorded in 1483 patients who stayed on a virologically failing therapy, providing an incidence of 14.5 cases per 100 patient years of follow-up. Of these new AIDS-defining illnesses, 189 (13%) were diagnosed in the first month of follow-up.

A total of 310 patients who took anti-HIV therapy and had an undetectable viral load developed an AIDS-defining illness, an incidence of 4.5 cases per 100 patient years. Of these, 59 (19%) occurred during the first month of follow-up.

For each group of patients the incidence of new AIDS-defining events was higher for patients with a CD4 count below 50 cells/mm3 compared to those with a CD4 cell count between 150 – 200 cells/mm3. New AIDS-defining illnesses also occurred more frequently in patients with a baseline viral load above 30,000 copies/ml compared to patients with a baseline viral load below this value.

When the investigators looked at the incidence of individual AIDS-defining events, they found that each occurred with significantly greater frequency in patients who interrupted therapy than amongst patients who either remained on a virologically failing regimen, or amongst patients who took treatment and had an undetectable viral load.

Overall, amongst patients with a CD4 cell count below 50 cells/mm3, compared to individuals who interrupted therapy, those who remained on treatment with a detectable viral load were 22% less likely to develop a new AIDS-defining illness, with patients with an undetectable viral load some 62% less likely to progress to a new AIDS event.

For patients with a CD4 cell count between 50 – 200 cells/mm3, compared to patients who stopped anti-HIV treatment, individuals who continued therapy with a detectable viral load were 34% less likely to progress to a new AIDS event, with treated patients with an undetectable viral load being some 73% less likely.

”Patients with detectable viral load who continued antiretroviral therapy had lower incidence and risks of AIDS-defining events of all types than did patients who stopped their treatment, both in the overall population and after CD4 cell count stratification”, comment the investigators.

They add, “our study confirms that interruption of antiretroviral therapy has a negative prognostic impact, even in the most advance patients.”

”Maintenance of a failing drug regimen to which the patient’s HIV quasi-species is resistant may still interfere with viral replication and thereby slow the immunological and clinical deterioration”, suggest the investigators.

The investigators conclude, “our results suggest that, when profoundly immunodeficient HIV-infected patients have no further treatment options permitting effective viral control, maintaining a failing regimen is preferable to interrupting it.”

Reference

Kousiginian I et al. Maintaining antiretroviral therapy reduces the risk of AIDS-defining events in patients with uncontrolled viral replication and profound immunodeficiency. Clin Infect Dis 46: 296 – 304, 2007.

By Michael Carter, www.aidsmap.com