Welcome to The Body Pro Newsletter, a bi-weekly review of the latest breaking news and research in HIV medicine, aimed specifically at informing healthcare professionals.  
The Body Pro Covers: CROI 2005, Feb. 22-25, 2005

This Week: New JournalView, New Treatment Guidelines, New Antiretrovirals

April 13, 2005

  HIV TREATMENT & PATIENT CARE
 


Earn Fast, Free Credit at CME/CE Central!
NEW: Strategies for Switching and Simplifying Antiretroviral Treatment in HIV-Infected Patients: Research Update and Case Studies, by Edwin DeJesus, M.D., and David Wohl, M.D.
HIV Drugs in Development, 2004, by David Wohl, M.D. (Expires May 13)

UNUSED MEDICATIONS CAN SAVE AFRICAN LIVES

The Starfish Project

Do you or your patients have unused medications? The Starfish Project at NewYork-Presbyterian Hospital collects extra antiretrovirals and other HIV-related medications, which it then ships to healthcare providers in Nigeria. All shipping costs are reimbursed. Visit www.thestarfishproject.org or call (212) 746-7164 for more information.

 

     
 

New Issue of HIV JournalView Is Now Available
Need your monthly fix of the latest in HIV research? David Wohl, M.D., authors the newest issue of HIV JournalView, our regular recap of important, recently published studies on HIV-related topics. Wohl's enlightening summaries include a discussion of the relationship between adherence and HIV drug resistance, as well as the rationale behind, and cost-effectiveness of, widespread HIV screening of the general public. Click Here


U.S. Releases Updated HIV Treatment Guidelines (PDF)
The U.S. Department of Health and Human Services has updated its HIV treatment guidelines for adults and adolescents. While no significant changes were made to the recommendations regarding when to start therapy or which first-line regimens are preferred, some information was updated. For instance, as noted in a January 2005 public health advisory, nevirapine (Viramune) should no longer be prescribed as initial therapy to female patients with a CD4+ cell count above 250 or to male patients with a CD4+ cell count above 400, unless the benefits clearly outweigh the risks. Click Here


FDA Advisory Committee Will Discuss Tipranavir on May 19
On May 19 a U.S. Food and Drug Administration (FDA) advisory committee will hold a public meeting to discuss the approval of tipranavir (tentative brand name: Aptivus), a phase 3 protease inhibitor (PI) that has shown activity in HIV-infected patients with PI resistance. Public comment is welcome prior to, or during, the meeting; submissions are due by May 6. Click Here


TMC-114 Sets a New Standard in Salvage Therapy Trials
One of the most important studies -- particularly for treatment-experienced patients -- presented at the 12th Conference on Retroviruses and Opportunistic Infections may have been the interim phase 2 results on the new protease inhibitor TMC-114. When TMC-114 was given to treatment-experienced patients, a viral load below 50 copies/mL was achieved by 37% of patients. However, when it was given with enfuvirtide (T-20, Fuzeon), the viral load of 67% of patients fell to below 50 copies/mL. What makes this so impressive is that 48% of these patients had more than 3 primary PI mutations. Ian Frank, M.D., reports for The Body Pro. Click Here


Antiretroviral Pipeline Update: Dozens of Drugs in Development
Dozens of antiretrovirals are now in various stages of development, with nearly 20 drugs in various phases of clinical trials. This chart outlines the status of each of these nascent drugs, from those in existing classes (e.g., capravarine, TMC-278) to those with new mechanisms of action (e.g., CCR5 inhibitors, maturation inhibitors). Click Here


Ugandan Study on Nevirapine in Pregnant Women Remains Sound, Despite Shortcomings, Panel Finds
There is no evidence of serious flaws in the HIVNET 012 study -- a trial examining the use of nevirapine (Viramune) among pregnant women in Uganda -- that would cast doubt on the study's findings, according to a report released by an independent review panel of the Institute of Medicine. "None of the shortcomings that we discovered upon reviewing the data and conducting our own original analysis of source documents indicates a need to retract or discount the study's findings," the chair of the review panel said. Click Here


New Drug Interactions Added to Ritonavir, Lopinavir/Ritonavir Labels
The labeling for ritonavir (Norvir) and lopinavir/ritonavir (Kaletra) have been updated to include new information about drug interactions with fluticasone, a component of Flonase nasal spray, and the antidepressant trazodone (Desyrel). The 2 drugs are no longer recommended for use with ritonavir or lopinavir/ritonavir unless their potential benefit is deemed to outweigh their risk. Ritonavir's package insert was also updated with a new contraindication to the concurrent use of alfuzosin (Uroxatral). Click Here


Genetic Testing Could Help Some Avoid Ritonavir Side Effect
Could genetic testing someday play a key role in selecting a new HAART regimen? A recent study suggests it might be a useful tool, particularly before prescribing a regimen that includes ritonavir (Norvir). In some patients, ritonavir causes a severe rise in triglyceride levels. Researchers have pinpointed a specific genetic mutation that makes a patient taking ritonavir more likely to have this adverse effect, which could help clinicians prescribe a less-risky, ritonavir-free regimen instead. Click Here

 
   

  HIV/HAART-RELATED COMPLICATIONS
     
 

Avoiding Enfuvirtide Skin Reactions: The Chubbier, the Better?
Virtually all patients receiving enfuvirtide (T-20, Fuzeon) experience injection site reactions. Unfortunately, the absence of subcutaneous fat may make those injection site reactions worse -- an unsettling possibility for the many lipoatrophy patients who use, or may soon need to use, enfuvirtide. Timothy Wilkin, M.D., reports on this issue for The Body Pro, as part of our coverage of the 12th Conference on Retroviruses and Opportunistic Infections. Click Here


Efavirenz-Associated Neural Tube Defects Reported in Infants; Pregnancy Category Changed From C to D
The pregnancy category for efavirenz (Sustiva, Stocrin) has been changed from Category C to Category D, following 4 retrospective reports of neural tube defects in infants born to HIV-infected women who were exposed to efavirenz-containing antiretroviral regimens during their first trimester. Three of the 4 cases were of meningomyelocele; the fourth was of Dandy-Walker Syndrome. Drugs are classified as Category D when positive evidence of risk to a fetus is confirmed. Click Here


FDA Approves New Hepatitis B Medication
The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's Baraclude (generically known as entecavir), an oral drug for the treatment of chronic hepatitis B infection. Click Here


HIV's Metabolic Effects Differ by Gender, Race and Age
We have long known that HIV itself can have metabolic manifestations, which include increasing levels of blood fat and sugars, as well as an increased risk for complications such as cardiovascular disease and diabetes. But little is known about how these metabolic problems differ between genders, races and ages. A recent study by U.S. researchers suggests that there is a difference -- and that women, African Americans and younger people may actually be at a lower risk for some of these HIV-related complications than others. The study was conducted among patients who had never received HAART. Click Here


Scant Evidence That Hepatitis C Can Be Transmitted Sexually
Is hepatitis C a sexually transmitted disease? Not all researchers agree. But in one of the largest studies ever to examine the question of sexual transmission of hepatitis C, Canadian researchers found virtually no evidence that the virus can be passed sexually from one person to another -- at least when it comes to HIV-uninfected men who have sex with men. The 8-month study of 1,054 gay men found only one case of hepatitis C transmission -- and the man who was infected said he'd also recently shared injection drug equipment. Click Here


HIV and Cocaine Use Increase Coronary Calcification Risk
HIV-infected patients who use cocaine may be increasing their risk of coronary calcification, according to a study authored by Johns Hopkins researchers and published in the March 28 issue of the Archives of Internal Medicine. The researchers found that both HIV status and cocaine use were linked to a greater risk for coronary calcification -- and that when those 2 factors occurred concurrently, the risk was even higher. Click Here


U.S. Physician Locator Launched for Poly-L-Lactic Acid Treatment
Dermik Aesthetics, which produces the lipoatrophy treatment poly-L-lactic acid (Sculptra, New-Fill), has created a database to help patients in the United States find physicians in their area who administer the product. Physicians can add themselves to the list by submitting a form provided by a product sales representative. Click Here

 
   

  MENTAL HEALTH
   
       
 

Insomnia Common in Depressed, HIV-Infected Patients
HIV-infected patients who are depressed are more likely to suffer insomnia, potentially adding to the burden of their disease, according to a meta-analysis by British researchers of 29 previously published medical journal articles. Click Here


Case Study: Acute Psychosis in a Treatment-Experienced Patient
What's the best way to manage a treatment-experienced, incarcerated, HIV-infected patient with acute psychosis? Given his extensive resistance to protease inhibitors, is efavirenz (Sustiva, Stocrin) use worth the potential risks? Bethany Weaver, D.O., M.P.H., examines this question and more in this select case study. Click Here

   
     

  U.S. HIV/STD EPIDEMIOLOGY
   
       
 

Colorado's I-70 Corridor, Home to Top Ski Resorts, Reports High HIV Prevalence
Colorado counties along the Interstate 70 corridor west of Denver, which is home to some of the nation's most popular ski resorts, have some of the highest HIV prevalence rates among rural areas of the state. About 10% of the 14,515 HIV-infected people living in Colorado in 2004 lived in 4 counties -- Eagle, Garfield, Pitkin and Summit -- along the corridor, and the number of HIV cases increased in all 4 counties from 2001 to 2004, according to the Colorado Department of Public Health and Environment. Click Here


California Teens View Oral Sex as More Common, Less Risky Than Intercourse
U.S. teenagers generally view oral sex as a more acceptable, less risky alternative to vaginal sex, according to a study of an ethnically diverse group of ninth-grade California students. The study was published in the April issue of Pediatrics. The researchers found that 20% of the teens surveyed said they had engaged in oral sex, while 14% said they had engaged in vaginal sex. (The study did not ask students about homosexual contact or anal sex.) Boys and girls reported similar experiences and opinions. The study also found that teens rarely reported using condoms or dental dams during oral sex. Click Here


A Virulent HIV Case, a Connecticut Doctor and a New York Bathhouse
As investigators continue their work to trace the origins of the case of rapidly progressing, multi-drug resistant HIV in New York City that exploded onto newspapers in February, plenty of theories continue to circulate. One of them surrounds a Connecticut physician named Gary Blick, who decided to issue a press release in March claiming that one of his patients appears to have a strain of HIV related to the one found in the New York City man. Blick believes a particular bathhouse in New York may have been the place where several different HIV strains found their way into the New York City man, eventually giving rise to February's public health alarm. Click Here


New York Researchers Looking Into HIV-Infected Man's Sexual Contacts
Investigators are largely remaining silent about new developments in the New York City case, but a press release late last month from the New York City Department of Health acknowledges that several possibly related cases are being examined. However, officials would not say exactly how many such patients had been identified, and said it could take several months to determine if there is any connection. Click Here


Heterosexuals Diagnosed With HIV at Later Stage Than Homosexual, Bisexual Men
HIV-infected heterosexual men and women present for HIV testing at a later stage of infection than homosexual and bisexual testers, according to a prospective observational study by British researchers. The authors defined late presentation as testing positive for HIV with a baseline CD4+ cell count less than 200. Their study appears in the December 2004 issue of the International Journal of STD & AIDS. Click Here

   
     

  HIV PREVENTION
   
       
 

Group of U.S. Researchers Backs Routine HIV Screening for All
HIV testing is essential for all sexually active persons -- regardless of their perceived risk -- in order to reduce the number of people in the United States who are unaware of their infection, advises an April 1 editorial in Clinical Infectious Diseases authored by several HIV clinicians, including John G. Bartlett of Johns Hopkins University. The editorial follows a pair of studies published in the New England Journal of Medicine in February that generally cast a positive light on universal HIV screening. Click Here


Microbicide Pilot Study Shows Promise in Women
An experimental microbicide gel for women might help prevent the spread of HIV and the herpes simplex virus, according to pilot study data presented at the 12th Conference on Retroviruses and Opportunistic Infections. Marla Keller and colleagues from Mount Sinai School of Medicine in New York City found that the experimental microbicide PRO 2000 significantly reduced viral levels in the vaginal secretions of HIV-infected women, without causing an inflammatory response. Click Here

   
     

  HIV PATHOGENESIS
   
       
 

SIV Infection Wipes Out Half of CD4+ Cells Within 4 Days, Studies Find
Two U.S. studies published in Nature and conducted on SIV-infected monkeys found that during acute infection, SIV immediately wipes out more than half of the CD4+ cells that might have recognized and helped fight the virus. "Specifically, 30 percent to 60 percent of CD4 memory T-cells throughout the body are infected by SIV at the peak of infection, and most of these infected cells disappear within four days," Roederer and colleagues wrote. "Furthermore, our data demonstrate that the depletion of memory CD4 T-cells occurs to a similar extent in all tissues." Click Here

   
     

  HIV/AIDS ADVOCACY & U.S. POLICY
   
       
 

Can We Do More to Prevent a Different Kind of Holocaust?
As he watched Holocaust survivors commemorate the 60th anniversary of the liberation of Nazi concentration camps at the end of World War II, José Zuniga, the president of the International Association of Physicians in AIDS Care, couldn't help but wonder what the world would say long after the eradication of HIV/AIDS. "I wonder if, as with the images of the dead and the 'walking dead' taken at the infamous Auschwitz-Birkenau concentration camp, images of the ravages wrought by AIDS will provoke in us all feelings of regret and shame at not having done more sooner," he writes. Click Here


U.S. Senate Budget Resolution Axes Medicaid Cuts, Nearly Triples Global Fund Money
The U.S. Senate narrowly approved a fiscal year 2006 budget resolution that would reject President Bush's proposed $14 billion in cuts to Medicaid over the next 5 years, and would increase U.S. funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria to $800 million from the $300 million requested by the president. The resolution must still be reconciled with the House of Representatives' own budget resolution, which includes the Medicaid cuts. Click Here

   
     

  HIV/AIDS OUTSIDE THE UNITED STATES
   
     
 

South Africa: Contaminated Instruments, Breast Milk Switching May Increase Infant HIV Risk
Blood-stained medical instruments and accidental switching of stored breast milk in some public hospitals in South Africa's Free State province are increasing the risk that children might contract HIV in healthcare settings, according to a newly released study of 4,000 women and their children in the province. According to the study, 17.5% of the instruments used for maternity and pediatric patients had visible blood on them, and 24% of the instruments were contaminated with blood not visible to the human eye. In addition, bottles of breast milk in the hospitals were labeled by cot number, not the name of the infant, which allowed potentially HIV-infected milk to be fed to the wrong infant if the cot was moved. Click Here


In Uganda, the Debate Rages: Was It A, B or C That Lowered HIV Rates?
The remarkable strides Uganda has made against HIV have been muddied by a heated debate over which part of the "ABC" method -- Abstain, Be Faithful, Use Condoms -- was most responsible for the country's decline in HIV prevalence. Interim results from an intensive study, presented at the 12th Conference on Retroviruses and Opportunistic Infections, don't appear to shed much new light on the debate: They seem to indicate that during the 1994-2003 period in one Ugandan district, HIV prevalence dropped mostly because HIV incidence remained steady, while AIDS-related deaths actually reduced the overall number of people with HIV. The implication of these findings is that the country's true strides against HIV occurred before 1994 -- a period that the study did not investigate. Click Here


Indians More Likely to Experience Faster HIV Disease Progression
A study in India has found that a gene associated with faster progression from HIV to AIDS is 2.5 times more common in Indians than another, more protective gene, according to a study conducted by researchers at India's premier medical school. The study results were reported by BBC News. Previous research has found that the gene, HLA-B*35-Px, substantially accelerates the rate of HIV disease progression. Click Here


In Africa, Hope That a New Pope Will Bring a New Stance on Condoms
HIV prevention workers and AIDS advocates throughout Africa hope that the imminent selection of a new pope to lead the Roman Catholic Church will lead to a less-rigid stance regarding the use of condoms to prevent the transmission of HIV -- or, at the very least, a clearer argument for responsible sexual behavior among all people, HIV-infected or HIV-uninfected, married or single. Click Here


HIV Is National Security Threat, Russian Officials Say
"The growth of AIDS has gone beyond being a medical problem only and has become an issue of strategic, social and economic security of the country within the current demographic situation in Russia," said Russian Deputy Prime Minister Alexander Zhukov at a recent meeting on the role of the state and private sector in Russia's fight against HIV. Health Minister Mikhail Zurabov also announced at the meeting that Russia has reached agreements with several international pharmaceutical companies that will allow HIV-infected Russians to pay about US$3,000 annually for antiretroviral medication; treatment currently costs about US$10,000. Click Here

 
     
 
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