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AIDS Treatment Should Start Sooner, Gilead AIDS Pill Effective in Study With Weekends Off, AIDS Vaccine Poised for Human Tests

The AIDS ReaderThe AIDS Reader Vol 18 No 12
Volume 18
Issue 12

A new study presented at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC, suggests that persons infected with HIV should begin antiretroviral treatment sooner than guidelines currently recommend (Marchione M. Associated Press. October 26, 2008). The large study finds that delaying antiretroviral therapy until patients’ T-cell counts fall below 350/µL nearly doubles the risk of death in the next few years of their lives when compared with the risk of death in patients whose treatment was started earlier.

AIDS Treatment Should Start Sooner
A new study presented at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC, suggests that persons infected with HIV should begin antiretroviral treatment sooner than guidelines currently recommend (Marchione M. Associated Press. October 26, 2008). The large study finds that delaying antiretroviral therapy until patients’ T-cell counts fall below 350/µL nearly doubles the risk of death in the next few years of their lives when compared with the risk of death in patients whose treatment was started earlier.

“The data are rather compelling that the risk of death appears to be higher if you wait than if you treat,” said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which cosponsored the study. Antiretrovirals have helped transform HIV/AIDS from a death sentence to a manageable disease. But the drugs can cause serious adverse effects, and poor regimen adherence can breed a drug-resistant virus. International AIDS Society–USA guidelines, therefore, recommend that patients who do not yet display AIDS symptoms delay starting antiretroviral therapy until their T-cell counts drop to below 350/µL.

Dr Mari Kitahata of the University of Washington, Seattle, and colleagues studied 8374 US and Canadian patients with T-cell counts of 351 to 500/µL from 1996 to 2006. Around 30% began antiretroviral treatment right away; the rest followed the guidelines. “We found a 70% improvement in survival for patients who initiated therapy between 350 and 500,” compared with those who waited, said Kitahata.

The study’s findings build on 2 other recent reports showing that persons who start taking AIDS drugs while their T-cell count is above 350/µL have a better chance of their count returning to normal-healthy persons have T-cell counts of more than 800/µL-than those who start treatment later. However, as many as a third of HIV-infected persons only learn they are infected after their T-cell counts have already dropped below 350/µL. “People are still being tested and identified way too late,” said Dr Daniel Kuritzkes, an AIDS specialist at Boston’s Brigham and Women’s Hospital. The new study underscores the importance of earlier HIV testing and diagnosis, he said.

The study’s findings do not apply to HIV-infected patients who also have hepatitis, kidney damage, or other medical problems, or who are pregnant. Doctors have long advised these patients to begin treatment as soon as they receive the diagnosis. [CDC HIV/Hepatitis/STD/TB Prevention News Update Monday, October 27, 2008]

HIV Doctors May Treat All Infected, Adding Thousands
In light of recent research, public health experts are reevaluating when HIV-positive patients should begin antiretroviral treatment (Lauerman J. Bloomberg News. October 29, 2008).

Because of concerns about medication adverse effects and the drug-resistant virus that can develop when regimens are not closely followed, treatment guidelines had long counseled delaying the initiation of antiretroviral treatment until a patient’s CD4+ cell count dipped to 200/µL. This year, the US Department of Health and Human Services and the International AIDS Society said that asymptomatic patients should start treatment when their CD4+ cell counts fall to 350/µL. A healthy person’s CD4+ cell count is 600 to 1200/µL.

Most recently, scientists at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC, were told that raising the treatment threshold to a CD4+ cell count of 500/µL would save lives. Some doctors are saying that this study and other research may soon force changes to the recommendations and would put all HIV-infected patients on antiretroviral drug regimens.

“We may be heading for a time when all patients are benefiting from HIV treatment,” said Paul Sax, a Harvard Medical School AIDS expert who helped write the current guidelines. Sax said a growing number of studies suggest that non–AIDS-related complications, such as heart disease and cancer, are more common among treatment-naive HIV-infected patients with relatively high CD4 counts. “It’s looking more and more like whatever deleterious effects the medications have are outweighed by controlling the virus and maintaining immune status,” Sax said.

Studies also suggest that those who achieve undetectable viral loads through medication are less likely to transmit HIV-another reason earlier treatment is getting new consideration. “This is very, very actively on everyone’s mind,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “The new data seem to indicate that there’s an advantage to starting earlier.” [CDC HIV/Hepatitis/STD/TB Prevention News Update, Wednesday, November 5, 2008]

Gilead AIDS Pill Effective in Study With Weekends Off
In a new study, patients who took a 3-in-1 combination AIDS pill 5 days a week fared just as well as those who took the drug every day. The results could have important implications for both the cost of AIDS care and the ability of patients to comply with treatment regimens (Lauerman J. Bloomberg News. November 11, 2008).

The Harvard Medical School study-presented Tuesday, November 11, in Glasgow, Scotland, at the International Congress on Drug Therapy in HIV Infection-involved 60 patients for whom Gilead Sciences Inc’s once-daily drug Atripla was prescribed. All patients took the drug, which combines emtricitabine and tenofovir (Truvada [Viread and Emtriva]) with efavirenz (Sustiva), every day until they achieved undetectable viral loads in their blood. Half of the patients then continued with daily dosing, while the other half began taking the drug on weekdays only. The patients on the reduced dosing plan kept their viral loads just as low during the 6-month study as those who took the medicine every day, said Calvin Cohen, one of the researchers. Monitoring of the patients will continue for a year. “From an economic point of view, it’s a big deal,” Cohen said. “This may provide one way to minimize the cost of what is undeniably one of our best regimens.” A 30-day supply of Atripla costs $1362, according to Gilead.

In addition, patients preferred the 5-day dosing plan. “In many people’s lives there’s a weekday life and a weekend life, and that’s been true since they were 5 years old,” Cohen said. “We wanted to build on that well-ingrained human construct.” Longer, larger studies are needed, however. Cohen cautioned: “I’m not pretending this is the standard of care. The field deserves much more robust data set before adopting something like this.” [CDC HIV/Hepatitis/STD/TB Prevention News Update, Wednesday, November 12, 2008]

AIDS Vaccine Poised for Human Tests
Animal toxicology trials of an experimental Canadian AIDS vaccine could begin within days, the University of Western Ontario (UWO), London, Ontario, announced Wednesday, November 12. The vaccine candidate was developed by UWO virologist Dr Chil-Yong Kang. The animal testing will take place at a US research facility and may yield results in 3 months, Kang said. Phase 1 human trials could begin in early spring (Rynor B. Edmonton Journal. Huber J. Canwest News. November 13, 2008).

The vaccine uses whole, deactivated HIV-1, an approach similar to that for the polio vaccine developed by Jonas Salk, Kang said. “We have engineered a virus in such a way that it can be produced in larger quantities in shorter periods of time and it is also nonpathogenic,” he said. “In other words, it doesn’t cause the disease. We have tested animals and they do respond to the vaccine, and we now have to try it in humans.” The product will be tested in HIV-infected patients whose disease has not progressed to AIDS, said Kang.

The university also announced it is 1 of 4 Canadian organizations bidding for a grant to construct an HIV vaccine manufacturing facility. The plant would be scaled for small pilot clinical studies rather than for widespread manufacture. The Canadian government and the Bill & Melinda Gates Foundation are offering Can $88 million (US $72 million) for the project. Federal officials declined to name the other 3 contenders. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Friday, November 14, 2008]

No Proof That Circumcision Cuts Gay Male HIV Risk
There is insufficient evidence to support male circumcision as a way to protect against HIV infection or other sexually transmitted diseases for men who have sex with men (MSM), CDC researchers reported on Tuesday. This conclusion was based on a meta-analysis of 15 studies involving 53,567 MSM from the United States, Britain, Canada, Australia, India, Taiwan, Peru, and the Netherlands (Dunham W. Reuters. October 7, 2008).

Earlier studies of male circumcision in Africa, where the route of viral transmission is largely heterosexual, showed that circumcised males had up to a 60% reduction in their risk of contracting HIV from females. However, the effect of circumcision among MSM remained unclear.

In the new report, circumcised MSM were 14% less likely to be HIV-infected than uncircumcised MSM. But that proportion did not reach a level of statistical significance, the CDC team said. “You can’t necessarily say with confidence that we’re seeing a true effect there,” said Gregorio Millet, who led the study. “Overall, we’re not finding a protective effect associated with circumcision for gay and bisexual men. . . . We really cannot recommend overall male circumcision as a strategy for [MSM] in the United States.”

Circumcision might protect some MSM depending on their sexual role, Millet said. Research in Australia and Peru found that MSM who practiced exclusively insertive anal sex and were not being penetrated by male partners were significantly protected from HIV infection by being circumcised, he said. “Of course, if you’re being penetrated by a partner during sex, you being circumcised is not going to protect you from HIV infection,” noted Millet.

The full report was published in the Journal of the American Medical Association (Millett GA, Flores, SH, Marks G, et al. Circumcision status and risk of HIV and sexually transmitted infections among men who have sex with men. JAMA. 2008;300:1674-1684). [CDC HIV/Hepatitis/STD/TB Prevention News Update, Wednesday, October 8, 2008]

Male Circumcision Booms in Uganda
Responding to studies showing that male circumcision reduces the chance of female-to-male HIV transmission by about 60%, Uganda’s health ministry is planning to promote the procedure countrywide (Agence France Presse. October 7, 2008).

Many men from East African tribes who do not traditionally practice male circumcision are now opting to undergo the operation. In neighboring Kenya, Prime Minister Raila Odinga endorsed circumcision for the same reason, although some elders in his Luo tribe are wary because the procedure is not part of cultural traditions.

Circumcision in Uganda has been associated with the dominant eastern Bugisu tribe, which has practiced it as a rite of adulthood for centuries. The age of males who are circumcised varies from clan to clan, between 14 and 25 years. HIV/AIDS has forced tribes to switch from using a knife communally to individually about 10 years ago. Ugandan officials hope to change the tribal association, emphasizing medical circumcision for adolescents before they become sexually active.

“Some support circumcision, others trash it, but if you can get an intervention that can contribute to the reduction of infections, you have to support it,” said Dr Kihumoro Apuuli, head of Uganda’s AIDS Commission. One criticism is that circumcised males may defeat the protective effect by having sex before the wound heals or taking fewer precautions, he said. “It is an in-born thing,” said Geofrey Natubu, the vice chairperson of Bududa District, who recently officiated at a tribal circumcision event. “We don’t force you. If my son tells me he wants to be circumcised, I will ask him if he is confident that he is going to manage.” Custom dictates that youths undergoing traditional circumcision not express pain. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Wednesday, October 8, 2008]

Drug-Resistant HIV Strains Turning Up in China
A top AIDS researcher is warning of the emergence of drug-resistant HIV strains in China as the virus moves beyond high-risk groups into the general population (Tan Ee Lyn. Reuters. October 10, 2008). The trends are “alarming,” since the country has only 7 of the more than 20 different HIV/AIDS drugs in existence, meaning patients have limited options once they develop resistance to certain drugs, said Chen Zhiwei, director of the AIDS Institute in Hong Kong.

“All these drug-resistant mutations are in China now, they are emerging in Chinese patients,” said Chen. “The major worry is whether the drug-resistant virus [strains] will spread. . . . We are studying whether that is happening, but that will be the case if you don’t provide proper treatment,” said Chen, adding that researchers have urged China to import more varieties of HIV drugs.

Adherence to HIV drugs is poor in China’s rural regions, in part because of a lack of patient knowledge, inaccessible health care, and too few health care workers to explain the importance of keeping to a regimen. Poor adherence can lead to the development of drug-resistant virus. China had some 700,000 HIV/AIDS cases as of October last year, up 8% from 2006. Some 38% of cases in 2007 were heterosexually transmitted-more than triple the 11% in 2005, when the majority of infections were among injection drug users and those who received blood transfusions. “This virus is moving into the general population,” said Chen. “We have to find a way to stop this or the change will be like South Africa. If there is no good prevention, transmissions will suddenly explode.” [CDC HIV/Hepatitis/STD/TB Prevention News Update, Friday, October 10, 2008]

US FDA Expands Approval for Johnson & Johnson HIV Drug
On Wednesday, October 22, Johnson & Johnson announced that its HIV drug Prezista (darunavir) has received US approval for patients just beginning treatment. Prezista was already approved for use in treatment-experienced patients with drug-resistant HIV (Reuters. October 22, 2008). The firm said the FDA also finalized its 2006 initial approval of Prezista, which had been contingent on follow-up studies. Additional studies verified the drug’s benefits, the company said.

HIV-infected patients beginning treatment with Prezista should take it with ritonavir and food for best results, said Johnson & Johnson. The protease inhibitor rit-onavir is used to boost levels of Prezista in the body by slowing its metabolism. Common Prezista adverse effects include diarrhea, nausea, headaches, and serious rashes, the FDA has said. In addition, cases of hepatitis and liver failure have been reported in Prezista patients.

Prezista is marketed in the United States by Tibotec Therapeutics, part of Johnson & Johnson’s division of Ortho Biotech Products. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Thursday, October 23, 2008]

Scientists to Test Tuberculosis Vaccine in Cape Town
Local researchers are enrolling adult volunteers in Cape Town, South Africa, in a phase 2 trial of a potential tuberculosis (TB) vaccine. The experimental vaccine, found safe in 1 smaller US trial, was developed by the Dutch pharmaceutical firm Crucell and the not-for-profit Aeras Global TB Vaccine Foundation (Kahn T. Business Day (South Africa). October 20, 2008).

The University of Cape Town’s Lung Institute and the South African Tuberculosis Vaccine Institute will begin immunizations within the next few weeks. The trial of the Aeras 402/Crucell Ad35 vaccine will involve 82 adults who are currently being treated for TB or who have recently had TB. A separate trial in Kenya will test the safety of the vaccine in healthy adults, all of whom will have previously received the BCG TB vaccine and some of whom will have had TB. BCG protects against meningitis and disseminated TB, which attacks organs such as the stomach or bones, but it does not protect against TB of the lungs.

“There are many potential uses for a new TB vaccine,” said Jerald Sadoff, Aeras’s president and CEO. “Therefore, it is important to determine a candidate’s safety and immune responses in those who have already been exposed or have had active disease.”

Cape Town was chosen for its high TB burden and good research infrastructure, said Sean Bennett, Aeras’s clinical project physician. South Africa had more than 337,000 new TB diagnoses in 2005, an 8% increase over 2004. The disease has been fueled especially within the past decade by HIV/AIDS, which ravages the immune system and leaves persons vulnerable to opportunistic infections. TB is the world’s second-leading deadly infectious disease, and it is the leading cause of death for the world HIV/AIDS population. [CDC HIV/Hepatitis/STD/ TB Prevention News Update, Wednesday, October 22, 2008]

HIV Infection May Cause Dangerous Blood Clots
Patients who interrupt HIV treatment have a higher risk of blood clots and other problems with blood vessels, even if they are relatively healthy, according to a recently published international study (Reuters. October 21, 2008). Researchers analyzed plasma samples from an earlier study that enrolled 5472 HIV-infected patients for either continuous antiretroviral treatment or episodic treatment based on CD4 count. The study was halted in 2006 because patients who interrupted treatment were far more likely to die early of conditions unrelated to AIDS.

James Neaton of the University of Minnesota and colleagues compared 85 patients who died early with 170 matched controls who survived. Among those who died during the study, higher levels of 3 biomarkers linked to inflammation were found: C-reactive protein, interleukin 6 (IL-6), and d-dimer. The study found that “IL-6 and d-dimer were strongly related to all-cause mortality.” “The magnitude of the increased risk of death associated with elevations of these biomarkers is clinically relevant,” said Neaton. “Research aimed at understanding whether treating elevated levels of these markers is beneficial is now needed.”

Inflammation generally is linked with cancer, many heart conditions, and possibly diabetes, and other research has shown that HIV infection affects the lining of the blood vessels and may increase blood clot risk. The researchers said it might be possible to treat this inflammation with new medications.

The report of the study was published in Public Library of Science Medicine (Kuller LH, Tracy R, Belloso W, et al; INSIGHT SMART Study Group. Inflammatory and coagulation biomarkers and mortality in patients with HIV infection,” PLoS Med. 2008;5:e203). [CDC HIV/Hepatitis/STD/TB Prevention News Update, Monday, November 3, 2008]

Use of Opioid Substitution Treatment Helps HIV-Infected Drug Users Maintain Adherence to Antiretroviral Therapy
Both access to and effectiveness of opioid substitution treatment (OST) contribute to sustaining adherence to highly active antiretroviral therapy in HIV-infected injection drug users (IDUs).

“To date, no data exist assessing the impact of either methadone or buprenorphine on adherence to highly active antiretroviral therapy in the long term,” the authors wrote. They designed the current study to determine whether receiving take-home methadone and buprenorphine may ensure better adherence to HAART in patients who contracted HIV through injection drug use. The researchers collected longitudinal data on adherence, OST, and patient behaviors beginning with their first HAART prescription (276 patients; 558 visits). The setting was outpatient hospital facilities delivering HIV care in Marseilles, Avignon, Nice, and Ile de France, France.

At their visits, patients were classified according to the type of OST they received and ongoing injection. Those patients who reported neither injection nor OST during the entire period were classified as abstinent and were used as a reference category. A logit model based on generalized estimation equations was used to identify nonadherence predictors.

Patients who stopped injecting during OST and patients who were abstinent evidenced comparable adherence after adjustments were made for alcohol consumption, depression, and self-reported adverse effects. Compared with abstinent patients, patients who reported drug injection, on OST or not, had a 2- or 3-fold risk, respectively, of nonadherence. “Both access to and effectiveness of OST contribute to sustaining adherence to HAART in HIV-infected IDUs,” the authors concluded. “These results advocate strongly the need of wider use of OST in countries scaling-up HAART where HIV is driven by IDUs.” The study results were published in Addiction (Roux P, Carrieri MP, Villes V, et al. The impact of methadone or buprenorphine treatment and ongoing injection on highly active antiretroviral therapy (HAART) adherence: evidence from the MANIF2000 cohort study. Addiction. 2008;103:1828-1836. doi:10.1111/j.1360-0443. 2008.02323.x. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Tuesday, November 4, 2008]

ASEAN-UN Study Finds Migrants Vulnerable to AIDS
A new report offers the first-ever analysis of current migration patterns and their link to HIV infection in the 10 member countries of the Association of Southeast Asian Nations (ASEAN). Produced jointly by ASEAN and the United Nations (UN), the new report says 1.5 million people-most of them of working age-are living with HIV in the region (Agence France Presse. November 13, 2008).

“Migrant workers are a vital force to national economies in Southeast Asia, yet when it comes to protecting their rights and ensuring HIV prevention and treatment, they are often among the forgotten,” said Ajay Chhibber, regional director for the UN Development Program.

The report found that HIV infection rates and risk behaviors are considerably higher among migrants than in the general population. “While migrants and their sexual partners are included as a vulnerable group in the national strategic plans of ASEAN countries, comprehensive programs to address their needs have yet to be developed, funded and implemented,” according to J.V.R. Prasada Rao, UNAIDS’ (Joint UN Programme on HIV/AIDS’) regional director.

Among the report’s findings was that HIV infection rates as high as 9.0% were noted among migrant fisherman in Thailand; the report has developed the region’s most comprehensive data on the epidemic. More than 1.5% of the adult population is HIV-infected in Cambodia, Myanmar, and Thailand. Although the report questioned the effectiveness of the sessions, it noted that Cambodia, Indonesia, the Philippines, and Vietnam have developed predeparture training in the prevention of HIV infection for documented migrants leaving to work in other countries. HIV infection among migrants is compounded by their lack of access to AIDS services and legal and social protection. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Monday, November 17, 2008]

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