JAMA Releases Several HIV/AIDS-Related Studies
The expansion of an antiretroviral drug treatment program in Lusaka, Zambia, has produced successful results over the last two years, according to a study published in the Journal of the American Medical Association, the New York Times reports. The study -- presented on Sunday at the XVI International AIDS Conference in Toronto -- was conducted by Jeffrey Stringer of the University of Alabama-Birmingham's School of Medicine and colleagues. The study examines the progress of people receiving HIV/AIDS care at 18 clinics through a Zambian governmental program (Altman, New York Times, 8/14). The researchers examined the results of the program between April 2004 and November 2005 among 21,755 people receiving HIV/AIDS care, including 16,198 individuals who started antiretroviral therapy (Stringer et al., JAMA, 8/16). The researchers found that since the government opened the clinics in April 2004, the number of AIDS-related deaths among study participants declined to similar numbers recorded among people in the U.S. taking antiretrovirals for at least three months, according to Stringer, who also works at the Center for Infectious Disease Research in Zambia. The researchers recorded five deaths per every 100 patient years among the Zambian participants, compared with 4.34 deaths per every 100 patient years recorded among patients at UAB. The majority of deaths among participants occurred during the first three months of treatment, according to the Times.
According to the researchers, there are several reasons the program has been successful, including support from Zambian officials; the government's decision to remove medical fees for people seeking HIV treatment; the use of nurses and physician assistants to alleviate the country's physician shortage; the implementation of a computerized monitoring system; and funding from the President's Emergency Plan for AIDS Relief. According to Stringer, the costs associated with providing antiretroviral treatment and monitoring the drugs' effects -- less than $300 annually per patient -- were less than the costs of training staff and overseeing patients and workers (New York Times, 8/14). The researchers concluded that substantial scale up of antiretroviral therapy "with good clinical outcomes is feasible in primary care settings in sub-Saharan Africa" (Stringer et al., JAMA, 8/16). Stringer said that the current challenge is to identify HIV-positive people earlier, so they can benefit from antiretroviral therapy. He added that "getting patients to come in before they are deathly ill" will require reducing the stigma surrounding HIV/AIDS in Zambia (New York Times, 8/14).
Four-Drug Versus Three-Drug Antiretroviral Combinations Study
A four-drug combination antiretroviral treatment is not better than a three-drug combination, according to a study presented Sunday at the AIDS conference and published in JAMA, the AP/Boston Globe reports (Johnson, AP/Boston Globe, 8/13). Roy Gulick of Weill Medical College at Cornell University and colleagues tested 765 HIV-positive people who were newly diagnosed and had not previously received treatment. Half the participants were given a standard three-drug therapy -- which included azidothymidine, efavirenz and epivir -- and half were given a four-drug treatment composed of the same drugs plus abacavir, AFP/Yahoo! News reports (AFP/Yahoo! News, 8/14). The study -- which was funded by NIH and conducted over three years at more than 40 U.S. sites -- finds there are no significant differences in the health of HIV-positive people taking the four-drug regimen compared with those taking the three-drug regimen (AP/Boston Globe, 8/13). The researchers found that 26% of the participants receiving the three-drug combination and 25% receiving the four-drug combination experienced "virologic failure," meaning that the HIV-positive person had to change treatment regimens to continue to suppress the virus. The study also finds that the time until the participants' first virologic failure is not statistically different among people taking the three- and four-drug combinations (Xinhua/People's Daily, 8/14). In addition, the study finds that the four-drug combination does not increase CD4+ T cell levels more than the standard three-drug combination (AP/Boston Globe, 8/13).
The researchers in the study wrote, "Adding abacavir as a fourth drug to the standard initial three-drug regimen did not change toxicity or adherence but provided no additional benefit" to the study participants (Xinhua/China Daily, 8/14). "Triple drug therapy has been the standard approach to treatment of HIV infection for a decade or so, but there's always been a question about whether we could do better with more drugs," Dan Kuritzkes of Brigham and Women's Hospital said, adding that the results of the study "reaffir[m] the potency of the current standard of care" (AP/Boston Globe, 8/13). According to Gulick, "Nineteen percent of the people in our study were women, and over half were people of color, ... so we're very confident this four-drug regimen offered no particular benefit" (Ricks, Long Island Newsday, 8/14).
According to the AP/Globe, the study finding is "welcome news" to advocates because adding a fourth drug to a treatment regimen would have cost states' "already overburdened" AIDS Drug Assistance Programs millions of dollars (AP/Boston Globe, 8/13). ADAPs are federal- and state-funded programs that provide HIV/AIDS-related medications to low-income, uninsured and underinsured HIV-positive individuals (Kaiser Daily HIV/AIDS Report, 7/17). "Keeping treatment regimens as simple as possible is also good news for people living with HIV/AIDS as adherence ... is better with easier and smaller regimens," Murray Penner of the National Alliance of State and Territorial AIDS Directors said. Jim Pickett of the AIDS Foundation of Chicago said that adding another drug to the three-drug regimen might increase side effects (AP/Boston Globe, 8/13).
Simplified Antiretroviral Drug Combination Effective for Maintenance
A simplified antiretroviral drug combination sustains virologic suppression and might be an effective maintenance therapy for some HIV-positive people, according to a study presented Sunday at the AIDS conference and published in JAMA, the CP/CBC News reports (Branswell, CP/CBC News, 8/13). Thirty-four HIV-positive people whose viral levels had been lowered for 48 weeks or longer were given a combination of atazanavir and ritonavir instead of a three-drug antiretroviral regimen to determine whether the former could be used as a maintenance therapy (Xinhua/People's Daily, 8/14). Susan Swindells of the University of Nebraska Medical Center and colleagues followed the progress of the participants for 24 weeks (CP/CBC News, 8/13). The study -- which was funded by Abbott Laboratories, Bristol-Myers Squibb and NIH -- was conducted between September 2004 and April 2006 (Xinhua/People's Daily, 8/14). Researchers found that after 24 weeks, 91% of the people who had switched to the simplified combination therapy continued to have suppressed viral loads. The researchers wrote that the results suggest a "simplified maintenance therapy" might suppress viral loads in HIV-positive people who never have experienced treatment failure (Loftus, Dow Jones, 8/13). "Maintenance therapy ... offers a treatment strategy with potentially less complexity, pill burden, long-term complications and cost," the researchers wrote (Xinhua/People's Daily, 8/14). They concluded, "These findings require confirmation in larger, randomized trials of this strategy" (Swindells et al., JAMA, 8/16).
Other JAMA Studies
To coincide with the AIDS conference, JAMA dedicated an issue entirely to HIV/AIDS-related reports and also published several other related articles. Headlines appear below.
- "A Novel Pattern of Lipoaccumulation in HIV-Infected Men" (JAMA, 8/16).
- "AIDS and Food Shortages" (Stephenson , JAMA, 8/16).
- "AIDS in South Africa" (Stephenson , JAMA, 8/16).
- "Biology of CCR5 and its Role in HIV Infection and Treatment" (Lederman et al., JAMA, 8/16).
- "Breast-feeding Plus Infant Zidovudine Prophylaxis for 6 Months Versus Formula Feeding Plus Infant Zidovudine for 1 Month To Reduce Mother-to-Child HIV Transmission in Botswana" (Thior et al., JAMA, 8/16).
- "HIV and Circumcision" (Stephenson , JAMA, 8/16).
- "HIV and Youth" (Stephenson , JAMA, 8/16).
- "HIV Prevention for a Threatened Continent: Implementing Positive Prevention in Africa" (Bunnel et al., JAMA, 8/16).
- "Metabolic and Skeletal Complications of HIV Infection: The Price of Success" (Morse/Kovacs, JAMA, 8/16).
- "Pre-Exposure Prophylaxis for HIV: Unproven Promise and Potential Pitfalls," (Liu et al., JAMA, 8/16).
- "Scale-Up of Voluntary HIV Counseling and Testing in Kenya" (Marum et al., JAMA, 8/16).
- "Treatment for Adult HIV Infection: 2006 Recommendations of the International AIDS Society-USA Panel" (Hammer et al., JAMA, 8/16).
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