•  HIV TREATMENT

Johns Hopkins Study Backs HAART Initiation at CD4+ Cell Count >350
HIV-infected patients who initiate therapy with a CD4+ cell count above 350 cells/mm³ are far more likely to return to a "nearly normal" CD4+ cell count than patients who initiate therapy with a CD4+ cell count below 350 cells/mm³, according to a study by Richard D. Moore and Jeanne C. Keruly of the Johns Hopkins University School of Medicine. The 655-patient observational study followed patients for a median of 46 months; it found that all patients generally experienced a significant CD4+ cell increase during their first year of therapy and eventually plateaued. However, patients who began HAART with a baseline CD4+ cell count above 350 cells/mm³ had a higher plateau CD4+ cell count than patients who began HAART with a baseline CD4+ cell count below cells/mm³. In their conclusion, the researchers explicitly recommend that HAART initiation be considered while a patient's CD4+ cell count is still above 350 cells/mm³. The study was published in the Feb. 1 issue of Clinical Infectious Diseases. Click Here


CD4+ Cell Percentage Predicts HIV Disease Progression
CD4+ cell percentage is as effective a predictor of HIV disease progression as absolute CD4+ cell count, according to the results of a large U.S. study published in the Feb. 1 issue of the Journal of Infectious Diseases. The observational study followed 1,891 HIV-infected patients who initiated HAART between 1997 and 2004; it found that a patient's CD4+ cell percentage at the time of HAART initiation predicted disease progression (defined as death or the development of a new opportunistic infection) independent of the patient's absolute CD4+ cell count (P = .002 for both variables). The findings lend support to the use of CD4+ cell percentage values in determining whether HAART should be initiated in antiretroviral-naive patients. Click Here

•  COMPLICATIONS OF HIV & HAART

FDA Approves New Lipoatrophy Treatment
The U.S. Food and Drug Administration (FDA) on Dec. 22 approved the use of a new, temporary facial filler to correct the symptoms of facial lipoatrophy in HIV-infected patients. The filler, known by the brand name Radiesse, consists of synthetic calcium hydroxylapatite suspended in a gel carrier, and is injected into the skin. It is already approved for use as a tissue marker, for the treatment of vocal fold insufficiency, and to correct certain dental defects, according to an FDA release. A 100-patient study found statistically significant improvements in cheek thickness through six months in HIV-infected patients with facial lipoatrophy; the majority of patients received a total of three injections during the study period: one at baseline, a second at one month and a touch-up at six months. Click Here


HIV or Antiretrovirals? New Data May Shift Debate Over Causes of Cardiovascular Complications
In the last several years, results from large studies have linked the use of some antiretrovirals to a greater risk of cardiovascular complications in HIV-infected patients. The precise role of HIV and antiretrovirals in the development of these complications has remained a matter of debate, however -- and now, a newly published study appears to establish a causal link between HIV and atherosclerosis. The researchers found and elucidated the means by which a protein within HIV can trigger a reduction in a patient's HDL cholesterol levels. "The data support the shift away from a paradigm of delaying or stopping [antiretroviral therapy] to reduce the risk of cardiovascular disease," the researchers write. Their study was published in the November 2006 issue of PLoS Biology. Click Here

In an analysis published in PLoS Medicine, Andrew Carr and Daniel Ory review the results of the HIV/atherosclerosis study and discuss the new questions it raises regarding the role of HIV and HAART in cardiovascular risk.


Cardiovascular Disease Risk Higher Among HIV/HCV-Coinfected Patients
HIV-infected patients who are coinfected with hepatitis C (HCV) are significantly more likely to have cardiovascular disease than HIV-monoinfected patients, U.S. researchers have found. In a study published in the Jan. 11 issue of AIDS, investigators analyzed data from 395 participants in a prospective cohort of HIV-infected patients with current or prior alcohol problems. After adjusting for age, the researchers found that HIV/HCV-coinfected patients were 4.65 times as likely to have cardiovascular disease, and 12.86 times as likely to have experienced a heart attack, as HIV-monoinfected patients. Click Here


Smoking Not Enough to Explain Higher Lung Cancer Incidence Among AIDS Patients
Unidentified risk factors may be partly to blame for a higher incidence of lung cancer among HIV-infected people, U.S. researchers suggest. Previous studies have indicated that lung cancer is more common among HIV-infected people than HIV-uninfected people, and that diagnoses tend to occur at a more advanced stage of cancer than among the general population. Some have theorized that the high prevalence of cigarette smoking among HIV-infected people may be partly to blame, but a new study published in the Jan. 11 issue of AIDS suggests other factors are at play. The study, a massive analysis linking 397,927 HIV-infected U.S. patients with cancer registries in six states, found elevated rates of lung cancer among HIV-infected people, with a particularly high incidence rate noted among AIDS patients under the age of 30. "Smoking could not entirely account for the observed elevation, especially among younger adults, suggesting a role for additional co-factors," the researchers write. Click Here


After Surgery, HIV-Infected Patients Generally Fare as Well as Uninfected Patients
HIV-infected patients fare as well as HIV-uninfected patients following surgical procedures, according to a large, new study -- a finding that may help sway recalcitrant surgeons and hospitals into performing operations on HIV-infected patients with satisfactory CD4+ cell counts and low viral loads. The California study, which was published in the December 2006 issue of the Archives of Surgery, matched 332 pairs of HIV-infected and HIV-uninfected patients who underwent similar surgeries. The investigators found that, although mortality was more likely among HIV-infected patients through one year of follow-up, the excess death risk was not related to the surgeries themselves. The researchers noted, however, that patients with a CD4+ cell count below 50 cells/mm³ or a viral load above 30,000 copies/mL were more likely to experience complications from their surgery, and that HIV-infected patients were generally more likely to experience pneumonia after surgery than HIV-uninfected patients. Click Here


HIV May Cause Permanent CD4+ Cell Damage in the Gut, Study Says
HIV begins damaging the immune system almost immediately after infection by destroying key cells in the lining of the gut, and antiretroviral therapy may not fully reverse the damage, according to a new study by U.S. and German researchers. The study, published in the December 2006 issue of PLoS Medicine, found that even patients who receive suppressive antiretroviral therapy during the acute stage of HIV infection do not experience complete immune reconstitution within mucosal cells in the gut. The investigators admitted that the significance of this finding is currently unknown, since there appeared to be no short-term clinical consequences in affected patients. Click Here

In this analysis published in PLoS Medicine, Ronald S. Veazey and Andrew A. Lackner further examine the results of the above study, and offer that the findings suggest a need for the development of therapies that more effectively target mucosal tissues in HIV-infected patients.

•  HIV TRANSMISSION

San Francisco Hands Out Condoms in Prisons, Despite Governor's Veto
San Francisco County is distributing condoms to prison inmates as part of a safe-sex education program, despite California Gov. Arnold Schwarzenegger's veto of a bill that would have allowed nonprofit organizations to do the same thing. Many county jails in California -- including those in Alameda, Contra Costa and San Joaquin -- ban condoms, and condoms also are not permitted in the 18 federal prisons in the state. San Francisco County -- which is one of seven jurisdictions nationally that distributes condoms to inmates -- avoids the prohibition on condom distribution by handing them out as safe-sex educational tools. Click Here

•  HIV IN THE NEWS

30% of All ACTU Research Sites May Close
Steep funding cuts will likely force the closure of 10 of the United States' 32 AIDS Clinical Trial Units (ACTUs), according to news reports. Officials from the National Institutes of Health (NIH) say that the cuts, which are part of a major restructuring of NIH-funded AIDS research, are necessary to modernize the country's research efforts. "Areas of emphasis needed to change because of the changing nature of the AIDS epidemic. These clinical trial groups began to be too individualized and did not bring other research needs into play," said Sandra Lehrman, director of therapeutics research in the Division of AIDS within the NIH's National Institute of Allergy and Infectious Diseases. However, Eric Lawrence -- co-chair of the Network Community Advisory Board, an offshoot of the NIH-backed AIDS Clinical Trial Group, which oversees the units -- noted the closings will reduce the number of people eligible for clinical trials to around 1,000. "Site closures and funding cuts will delay or halt advancement and further progress of HIV science," he said. The funding cuts are likely to force the closure of ACTUs in Dallas; Galveston, Texas; Indianapolis; Los Angeles; Minneapolis; New York City; Omaha, Neb.; Philadelphia; Providence, R.I.; and Sacramento, Calif. Click Here

A temporary cash infusion for the Hawaii AIDS Clinical Trials Unit in Honolulu will provide a reprieve for that program, which also faced closure due to funding cuts.


Wall Street Journal Investigation Suggests Ritonavir Price Skyrocketed to Protect Lopinavir/Ritonavir
Three years ago, Abbott Laboratories caused an uproar when it dramatically raised the cost of ritonavir (Norvir). The Wall Street Journal reported last week that documents and e-mails appear to support the contention that Abbott raised ritonavir's price tag in 2003 in an effort to protect its sales of lopinavir/ritonavir (Kaletra), which the company feared would lose market share to competing protease inhibitors such as atazanavir (Reyataz), which typically must be boosted with ritonavir. In December 2003, Abbott announced a 400% price increase for ritonavir, but did not alter the price of lopinavir/ritonavir. Abbott maintains that the ritonavir price hike was not meant to protect lopinavir/ritonavir sales, but simply to more accurately reflect the medical value of the drug. Click Here

•  HIV OUTSIDE THE UNITED STATES

Malaria Increases Viral Load in HIV-Infected Patients, Study Finds
Malaria infects hundreds of millions of people every year, mostly in developing countries, and HIV-infected patients are more susceptible to malaria due to their weakened immune response. A study published in the Dec. 8 issue of Science adds a disturbing twist: Investigators found that malaria can cause a sevenfold increase in an HIV-infected patient's viral load, leaving them more susceptible to complications and more likely to transmit HIV to others. In regions where both diseases are common, such as sub-Saharan Africa, researchers believe malaria may be to blame for about 5% of all new HIV infections. Click Here


High Costs Could Jeopardize Brazil's Free Antiretroviral Program
The rising cost of new HIV antiretrovirals could jeopardize Brazil's program to provide HIV treatment to its citizens at no cost. HIV drug resistance is growing more prevalent in Brazil, and the higher cost of new drugs with activity against resistant virus has increased the country's spending on HIV by 75% over the past two years. Although negotiations with pharmaceutical companies have yielded antiretroviral prices that are lower than those for any other country outside Africa, new antiretrovirals in Brazil can still cost up to $17,000 per patient annually, compared with hundreds of dollars per patient annually for older generic drugs. The increasing costs have sparked a national debate among health officials, drug companies and HIV advocates over how to sustain the program, and renewed debate over whether Brazil has the right to ignore patents and begin producing generic versions of newer antiretrovirals. Click Here