•  HIV TREATMENT

Darunavir Hepatotoxicity Warning Issued; Drug Labeling Revised
Darunavir (TMC114, Prezista) is now contraindicated for HIV-infected patients with severe hepatic impairment, according to new darunavir prescribing information. The revised labeling advises clinicians to consider interrupting or discontinuing darunavir in patients who experience new or worsening liver dysfunction while on the drug. Tibotec Therapeutics issued a "Dear Health Care Professional" letter this month announcing the labeling changes, which stem from findings that 0.5% of patients who received darunavir-based HAART through the drug's clinical development program developed drug-induced hepatitis.

To read the "Dear Health Care Professional" letter in its entirety, click here.


Atazanavir, Seeking a Place in First-Line Therapy, Stands Up to Lopinavir/Ritonavir at 48 Weeks
Atazanavir (Reyataz) was found to be virologically non-inferior to lopinavir/ritonavir (Kaletra) through 48 weeks in treatment-naive patients, according to results presented at CROI 2008 from the large CASTLE study. The data also appeared to show fewer adverse effects among patients on atazanavir versus lopinavir/ritonavir, which may have been the driving force behind the lower treatment discontinuation rate observed among patients with a low CD4+ cell count who took atazanavir versus lopinavir/ritonavir. In this interview with The Body PRO, study author Donnie McGrath, M.D., explains the study findings and their implications for the possible approval of atazanavir as a component of first-line HAART.


Researchers Warn of Drug Interaction Between Lopinavir/Ritonavir and Rosuvastatin
Clinicians may need to add rosuvastatin (Crestor) to the list of statin drugs that exhibit a pharmacokinetic interaction with lopinavir/ritonavir (Kaletra). A study of 15 subjects published in the Feb. 28 issue of JAIDS found that lopinavir/ritonavir use may dramatically increase concentrations of rosuvastatin: AUC increased 2.1 fold, while Cmax increased 4.7 fold. The researchers recommended caution when coadministering the two drugs until larger studies can flesh out the issue further.


Ten Years of Effective HAART Cannot Suppress HIV in GALT
Could one of the next great frontiers of HIV medicine lie in the gut? Gut-associated lymphoid tissue -- unattractively acronymed GALT -- has long been known as a prime HIV reservoir site. It often sports a greater HIV RNA level and lower CD4+ cell count than the bloodstream. According to new research, this differential persists even after nearly 10 years of effective HAART. The study was published in the March 1 issue of the Journal of Infectious Diseases.

Research is underway to determine the means by which HIV affects GALT, with the hopes of devising a method for disrupting it. As we reported in this newsletter last month, a study appearing in the March 2008 issue of Nature Immunology explains how researchers from the U.S. National Institute of Allergy and Infectious Diseases reportedly identified a previously undiscovered mechanism by which HIV commences its initial assault on GALT.


U.S. Releases Revised Pediatric HIV Treatment Guidelines
A revised edition of the "U.S. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection" has been released; it includes noteworthy changes in the timing of therapy initiation in HIV-infected children, the timing of diagnostic testing in HIV-exposed infants and information regarding recently approved antiretrovirals.

•  HIV/HAART-RELATED COMPLICATIONS

HCV Coinfection Not Uncommon Following Primary HIV Infection Among MSM, Study Finds
Hepatitis C (HCV) coinfection via sexual exposure may often follow on the heels of HIV acquisition among men who have sex with men (MSM), according to the findings of a British study published in the March 12 issue of AIDS. The study found that 7% of 155 MSM diagnosed with primary HIV infection at St. Mary's Hospital in London between 1999 and 2006 tested positive for HCV antibodies within a median of 23 months following their primary HIV infection diagnosis. All of the men reported no injection drug use in the three months before their HCV diagnosis; however, 91% reported recreational drug use, and 73% reported fisting. In a related study published in the same issue of AIDS, French researchers reported two cases of HIV/HCV-coinfected MSM who became superinfected with another strain of HCV, apparently after exposure through unprotected sex.


Pneumonia Vaccine Appears Protective for HIV-Infected Patients
Vaccination for pneumococcal pneumonia can reduce incidence of pneumonia among HIV-infected individuals, according to the results of a 1,626-patient U.S. study published in the April 1 issue of Clinical Infectious Diseases. The study, which examined a prospective cohort of patients with a greater number of pneumonia risk factors than the general population (including older age, black race and smoking), found that, after controlling for CD4+ cell count and viral load, vaccination with 23-valent pneumococcal polysaccharide vaccine reduced pneumonia risk by about 35% in HIV-infected patients. Prior to this study, it had been unclear whether the vaccine effectively prevented pneumonia in HIV-infected patients.

•  HIV TRANSMISSION

Rectal Microbicides Need More Funding and Attention, Advocates Say
Why has virtually all of the focus on microbicide development been vaginal, not rectal? "Unprotected anal intercourse is a driver in the AIDS epidemic among both men and women around the world," says Jim Pickett, chair of International Rectal Microbicide Advocates (IRMA). "Unfortunately, this fact is obscured by debilitating silence and stigma." In an effort to change this trend, IRMA released a report in February calling for a five-fold increase in funding for rectal microbicide research. The report lays out IRMA's plan to advance the development of rectal microbicides without slowing down the development of vaginal microbicides. (Web highlight from International Rectal Microbicide Advocates)

Click here to download a PDF of the full report, "Less Silence, More Science: Advocacy to Make Rectal Microbicides a Reality."


HIV Risk Increases for Mexican Migrants After They Arrive in U.S.
Add HIV to the long list of harsh realities of life for workers who migrate from Mexico to the United States. In search of a better life for themselves and their families, many migrant workers end up in desperate situations -- so desperate that, although in the morning they may line up outside a Home Depot looking for a manual labor job, by the evening they may find themselves hired out for male sex work. In this interview with The Body PRO at CROI 2008, Melissa Sanchez explains the distressing findings of her recent research on HIV risk factors among Mexicans who migrate to the United States.

•  HIV IN THE U.S. NEWS

NIAID Director Recognizes National HIV Awareness Day for Women and Girls
More than a quarter of new HIV/AIDS cases each year in the United States are women -- and most of those women contracted HIV through unprotected sex with men, according to U.S. Centers for Disease Control and Prevention statistics. In honor of National Women and Girls HIV/AIDS Awareness Day on Monday, March 10, National Institute of Allergy and Infectious Diseases (NIAID) director Anthony S. Fauci, M.D., reminded the United States of these data. He also discussed his department's support for the development of alternative HIV prevention methods, as well as research into gender-based disparities regarding HIV disease and HAART.


California County Opposes Ban on Blood Donations by Men Who Have Sex With Men
The government of Santa Clara County, Calif., is publicly opposing a long-standing U.S. Food and Drug Administration rule that prevents all men who have sex with men (MSM) from donating blood. The vote by the Santa Clara County Board of Supervisors is largely symbolic, but supervisors say they may eventually consider banning blood drives on county property. If they do so, they would be following a new trend: The president of San Jose State University recently halted blood drives on campus, arguing that they violated the school's anti-discrimination rules.


New York City Gets $102 Million in New Ryan White Grants
Often referred to as the "epicenter" of the U.S. HIV epidemic, New York City has seen an increase in its Ryan White Program funding for 2008, which will be used to fund a range of HIV-related services. The ever-increasing life expectancy of individuals with HIV creates an even greater need for a wide range of services geared toward the 99,000 HIV-infected people who live in the city. However, the $102-million price tag on this year's Ryan White grants is only slightly higher than it was in 2007, when the city received about $100 million.

•  HIV THROUGHOUT THE WORLD

HIV Plays Critical Role in South Africa's Rising Child Mortality
Every year, 75,000 children die in South Africa before their fifth birthday, and more than half of these deaths could be prevented by improving access to currently available medical interventions, according to a new report from the South African health department. South Africa is one of only a dozen nations with a growing child mortality rate, and HIV accounts for 35% of South Africa's child deaths, the report states.

Before the report's release, South African Health Minister Manto Tshabalala-Msimang demanded the removal of four pages of data describing the country's lack of progress on reducing child and maternal deaths. However, the report's authors insisted the figures be included; the four pages ultimately appeared as an addendum to the report.


Despite Free Health Care, Many Canadian HIV Patients Die Without Treatment, Study Finds
Although HIV treatment is free for all Canadians, approximately 40% of the 1,436 individuals who died from HIV-related illnesses in British Columbia from 1997 to 2005 never received antiretrovirals, according to a study by Julio Montaner, M.D., and colleagues at the B.C. Centre for Excellence in HIV/AIDS. According to Dr. Montaner, many HIV-infected patients may not seek treatment because they are struggling with more immediate problems, such as mental illness, homelessness, drug addiction and extreme poverty. He also warned that the actual number of HIV-infected Canadians dying without ever receiving treatment could be much higher, since an estimated one out of every four Canadians living with HIV are unaware of their status.


International Task Force Calls on Governments to Lift HIV-Related Travel Restrictions
A task force chaired by UNAIDS and the Norwegian government has issued a global call to end all HIV-related travel restrictions. According to the European AIDS Treatment Group, 74 countries restrict HIV-infected visitors, with 13 (including the United States) banning them outright. UNAIDS executive director Peter Piot said, "No other condition [besides HIV] has people afraid of having their baggage searched for medication ... with the result that they are denied entry or worse -- detained and then deported back to their country."

To read the European AIDS Treatment Group's full (albeit difficult-to-navigate) breakdown of every country's legal stance on the travel of HIV-infected people, click here.

You can also click here for more information on the United States' policy regarding HIV-infected visitors.