•  STRUCTURED HIV TREATMENT INTERRUPTIONS

Heavy Blow to HIV Treatment Interruptions as SMART Study Is Stopped
It is a sad moment for the many HIV healthcare providers and their patients who had hoped that a lifetime of daily treatment could be safely interrupted for a substantial period of time: The SMART study, a massive, international trial assessing the value of CD4+ cell count-guided HIV treatment interruptions, has been effectively cancelled just a few years into what was to be as much as a nine-year research effort. An interim analysis of study results revealed that patients who periodically interrupted therapy based on their CD4+ cell count experienced disease progression at more than twice the rate of patients who remained on constant treatment. This month, the trial organizers decided to terminate enrollment in the study, and to advise all participants who were currently on an HIV treatment interruption to immediately recommence therapy. Click Here


Questions and Answers About the SMART Study
Need a refresher on the purpose, construction and findings of the landmark SMART study? The U.S. National Institute of Allergy and Infectious Diseases has put together this question-and-answer sheet spelling out some of the most important details of this pivotal clinical trial. Click Here


Advocates Say SMART Should Not Be Last Word on STIs
The U.S. AIDS advocacy organization Treatment Action Group (TAG) has released a statement urging continued investigations into the merits of structured HIV treatment interruptions (STIs). In the statement, TAG points out that even though SMART was massive in scope, it was a single study on one type of HIV treatment interruption -- it focused solely on a CD4+ cell count-guided strategy. Many other HIV treatment interruption methods may still have clinical benefit, so it is still too early to call STIs a failure, TAG explains. Click Here


Advocacy Group Launches Sign-on Campaign Demanding SMART Continuation
Another U.S. AIDS advocacy group, the Center for AIDS Information and Advocacy, has circulated a sign-on letter demanding the continuation of SMART as a prospective cohort study. "This large, diverse, multinational study could still provide answers to valuable questions, even now that only the viral suppression arm remains," the letter reads. "To end an effort such as this in an attempt to save money ... would truly be a mistake given the long-term, clinical endpoint data that this cohort can provide." Click Here

•  HIV TREATMENT & PATIENT CARE

HIV-Infected African Americans on Treatment May Have Lower Dyslipidemia Risk Than Other Ethnicities
African Americans with HIV may be less likely than white or Hispanic HIV-infected Americans to develop lipid problems while taking antiretrovirals, according to a U.S. study published in the March 2006 issue of PLoS Medicine. The study found that, overall, HIV-infected African Americans on treatment had lower triglycerides, higher HDL cholesterol and lower non-HDL cholesterol than HIV-infected patients on treatment who were white or Hispanic. The researchers also found that Hispanic patients who possessed a certain variation of the gene apoC-III may be somewhat protected from hypertriglyceridemia. Click Here


Effect of HAART on CD4+ Cell Count May Be Weaker in HIV/Hepatitis C-Coinfected Patients
HIV/hepatitis C-coinfected patients appear to experience faster HIV disease progression than patients infected with HIV alone. But how does coinfection affect a patient's response to HIV treatment? A recent study by researchers from British Columbia, Canada, has found that hepatitis C coinfection may also slow the immune-restorative effects of HAART. The study, published in the Jan. 15 edition of the Journal of Infectious Diseases, showed that the CD4+ cell count of HIV/hepatitis C-coinfected patients appeared to rise much more slowly after initiating HAART than the CD4+ cell count of HIV-monoinfected patients. Click Here


Two NRTIs or Three? Makes No Difference When Taken With Efavirenz
When prescribing the potent antiretroviral efavirenz (Sustiva, Stocrin) as part of a first-line treatment regimen, there is no discernible difference in virologic response regardless of whether the regimen is completed with two NRTIs or three NRTIs, according to 144-week results from the landmark ACTG 5095 study. As Timothy Wilkin, M.D., reports for The Body Pro, treatment-naive patients responded excellently, regardless of the total number of medications in their regimen. However, both regimens appeared less successful in African-American patients -- and researchers have no idea why. Click Here


Atazanavir Package Insert Is Revised
The U.S. Food and Drug Administration (FDA) has approved a set of changes to the package insert for atazanavir (Reyataz). According to an FDA statement, the changes "reflect new in vitro inhibition data and clinical drug-drug interaction information regarding coadministration of atazanavir and/or atazanavir/ritonavir with proton pump inhibitors, H₂ receptor antagonists, methadone, rifampin, enteric-coated didanosine and tenofovir." Click Here


FDA Announces New, Easier-to-Read Labeling for U.S. Prescription Drugs
The U.S. Food and Drug Administration (FDA) has unveiled major revisions to the format of prescription drug package inserts. The revisions are part of an effort to make information for healthcare professionals and patients clearer and more concise. The new drug labeling requirements, which will be phased in gradually and will initially apply to newly and recently approved drugs, include the introduction of a table of contents, a “Highlights” section summarizing critical information, and a toll-free number and Web information for the reporting of adverse events. Click Here


A New Look at Abacavir + Lamivudine + Tenofovir: Why Did This Regimen Fail?
In 2003, researchers abruptly halted a study of a promising three-drug combination -- abacavir (Ziagen) + lamivudine (3TC, Epivir) + tenofovir (Viread) -- after it failed to suppress HIV in a surprisingly large number of patients. We may never know exactly what caused this regimen's unexpected failure, but as Daniel Kuritzkes wrote in a commentary in the Dec. 1, 2005 issue of the Journal of Infectious Diseases, the most likely answer may be a low genetic barrier to resistance: It takes only two point mutations, M184V and K65R, to make HIV resistant to all three antiretrovirals. Click Here

•  ANTIRETROVIRALS IN DEVELOPMENT

Study Findings May Support Once-Daily, Three-in-One HIV Medication
A once-a-day, fixed-dose combination drug containing all of the components of an effective HAART regimen has been developed by Bristol-Myers Squibb Company (BMS) and Gilead Sciences, Inc. According to the companies, the pill, which combines once-daily doses of efavirenz (Sustiva, Stocrin), emtricitabine (FTC, Emtriva) and tenofovir (Viread), has demonstrated bioequivalency to the drugs taken separately. BMS and Gilead plan to file for U.S. Food and Drug Administration approval of the drug during the spring of 2006, which would put it on track to approval by late this year. Click Here

The three component drugs within the experimental once-daily pill were compared to a regimen of efavirenz + zidovudine/lamivudine (Combivir) in a study recently published in the New England Journal of Medicine. The study found that efavirenz + emtricitabine + tenofovir generated a superior rate of virologic response to the control regimen, while causing fewer adverse events.


European Scientists Reveal 3-D Structure of HIV
Scientists have for the first time successfully illustrated the three-dimensional structure of HIV, according to a study published in the Jan. 10 issue of Structure. Because strains of HIV vary in size and shape, scientists have found it difficult to understand its structure, the study says. Stephen Fuller, a professor at Oxford University's Wellcome Trust Centre for Human Genetics, and colleagues took about 100 images of 70 individual viruses and compared them using a computer program. The researchers found that the cone-shaped core of HIV is as wide as the viral membrane, and the virus has spikes on the outside that it uses when attaching to CD4+ T cells. In addition, the study finds that HIV differs from most viruses in that its membrane, rather than its internal structure, defines its size, a feature that limits the way the virus can assemble. The scientists hope researchers can utilize the findings to devise new treatments for HIV infection. Click Here


CCR5 Inhibitors May Make HIV-Infected Patients More Susceptible to West Nile Virus
In the latest blow to an experimental subfamily of entry inhibitors called CCR5 antagonists, researchers have discovered that a genetic quirk might make individuals who take the drugs more susceptible to West Nile virus. The finding occurred during researchers' examinations of a small percentage of HIV-uninfected people who are known to possess a genetic mutation that prevents HIV from utilizing CCR5 receptors to infect host cells. The researchers discovered that this mutation also appears to make people more likely to contract West Nile virus -- and may make West Nile infection more severe. Scientists worry that patients who receive experimental CCR5 inhibitors may likewise be at a greater risk for West Nile. This would make it all the more important for patients involved in CCR5 inhibitor trials to avoid exposure to mosquitoes. Click Here


Experimental NNRTI Advances to Phase 3 Study
The “second-generation” NNRTI etravirine (TMC125) shows activity against NNRTI-resistant virus through 24 weeks, particularly when used in combination with other active agents, according to research presented at the 10th European AIDS Conference in November 2005. An international phase 3 study of etravirine in combination with an experimental protease inhibitor, TMC114, has commenced. Click Here


Integrase Inhibitors: First Clear Success in Human Trial
A 10-day monotherapy trial of MK-0518, currently the most promising of a new class of antiretrovirals known as integrase inhibitors, showed impressive antiviral activity in treatment-naive volunteers, according to study results presented at the 10th European AIDS Conference in November 2005. MK-0518 will advance to a 48-week dose-ranging trial. Click Here

•  HIV TESTING & PREVENTION

Atlanta Clinics Debate Use of Rapid Oral HIV Test
Three Atlanta clinics that provide HIV testing say they have not experienced false-positive result rates as high as those reported by some California and New York clinics using the OraQuick Advance Rapid HIV-1/2 Antibody Test on oral fluids. “We've certainly not had any major problems with the oral test and have had minimal false positives," said Michael Banner, the director of prevention services at Our Common Welfare. Nonetheless, Banner said his clinic had decided not to take any chances: "We've decided to go back to the finger prick test until we get a definitive answer from OraSure." OraSure and U.S. federal agencies are investigating factors that may have led to higher false-positive rates in some New York and California clinics. Click Here


FDA Will Accelerate Review of Australian Microbicide
The U.S. Food and Drug Administration (FDA) has granted "fast-track" review status for a microbicide gel developed by an Australian drug company. The accelerated status assures that the FDA will take about six months -- half the standard time -- to review the microbicide, called VivaGel. Despite the FDA's decision, however, several more studies are required to determine VivaGel’s efficacy and safety, so approval of the gel is not expected until late 2008, provided the studies are successful. Click Here

•  HIV POLICY IN THE UNITED STATES

Randall Tobias Nominated to Be New Administrator of USAID
Secretary of State Condoleezza Rice is reportedly expected to "unveil a restructuring of U.S. foreign assistance" that includes the nomination of Randall Tobias as the new administrator of USAID. Tobias, former chief executive of Eli Lilly and current head of the State Department's Office of the U.S. Global AIDS Coordinator, would obtain a rank equal to that of deputy secretary of state and would have a planning staff at the State Department. Click Here


Massachusetts Governor Pushes for On-Demand HIV Testing for Suspects Accused of Sexual Assault
Massachusetts Gov. Mitt Romney has filed a bill that would require "on-demand" HIV testing for suspects accused of rape or sexual assault if the survivor requests it. The bill would allow survivors to request the test if the alleged assailant has been indicted for, or formally charged with, the crime. The bill also would require the state's Office of Victims Assistance to form a proposal for keeping testing information confidential. Some lawyers and AIDS advocates are criticizing the measure, saying it would take away suspects' privacy rights, while doing little to provide useful information to rape and sexual assault survivors. Massachusetts is one of five U.S. states without such a law in place. Click Here

•  HIV OUTSIDE THE UNITED STATES

HIV-Infected Iranians Struggle With Stigma as Country Remains Silent
Veteran war correspondent Kevin Sites came across a different type of battle in his recent trip to Iran: the country's silent, but growing, struggle with HIV. The existence of the virus is barely acknowledged in this Middle Eastern country, resulting in a high degree of ignorance and stigma -- even among healthcare professionals. "Even the doctors are a little afraid of the disease," said one HIV-infected patient. "They tell me they aren't, but I know -- I can tell with the way they deal with me." Sites' coverage of Iran's HIV epidemic is available in this blog and multimedia report. Click Here


International Audit Lowers Estimated Number of HIV-Infected Chinese by 190,000
A joint report from the Chinese Health Ministry, the World Health Organization and UNAIDS seems to contradict a long-held belief that China's HIV prevalence is far higher than officially stated. Although estimates in 2003 said that the number of HIV-infected people in China was 840,000, the newly released report lowers that number to 650,000 in 2005 -- 75,000 of whom have developed AIDS. Although the report seems to somewhat reduce the urgency of China's HIV epidemic, it makes an effort to note that the situation in China is still highly volatile: In 2005, the report estimates, HIV incidence hit 70,000 and AIDS claimed the lives of 25,000 people. Click Here


Latin American and Caribbean Nations Team Up to Bargain for Lower Drug Prices
Nineteen Caribbean and Latin American nations plan to join together to negotiate a reduced price for HIV medications and, if necessary, to jointly produce the drugs themselves, Brazil's official news agency said. At a recent Latin American AIDS conference, the head of Brazil's AIDS program urged poor countries to break patents and produce their own versions of approved HIV medications -- a move that is permitted under World Trade Organization rules, provided there is a public health emergency and the country can't reach a pricing agreement with the drug company that holds the patent. The Brazilian official also noted that the annual cost of treating someone with HIV nearly doubled from 2003 to 2004, and now stands at US$2,500. Click Here


At Rare Free HIV Clinic in Nigeria, Doctors Take a Stand
Nigeria is home to more than three million HIV-infected people -- but, shockingly, the country has only two free HIV clinics, both operated by foreign groups. The Nigerian government charges far more for HIV care than most of its people can afford. It is for this reason that the larger of the two free clinics -- a nondescript medical office run by Medecins Sans Frontieres (MSF) -- is trying to serve as an example for the kind of care that Nigerian HIV-infected patients should receive. "We have to make this project a driving force for activism and a pain in the backside for government," an MSF official explained. Click Here