•  HIV ANTIRETROVIRALS & TREATMENT STRATEGIES

U.S. HIV Treatment Guidelines Updated, Urge Greater Use of Resistance Tests
Genotypic testing is now recommended for all patients prior to therapy initiation, whether they are acutely or chronically infected with HIV, according to updated guidelines for the treatment of HIV-infected adults and adolescents. The revised guidelines, which were released on May 4 by the U.S. Department of Health and Human Services, additionally recommend considering a resistance test for acutely or chronically infected patients for whom first-line therapy is being deferred. Also new in the guidelines is a detailed discussion of the proper manner in which to carry out short- and long-term treatment interruptions. No changes to the guidelines have been made regarding recommendations for when to initiate HAART or which antiretrovirals to prescribe as first-line therapy. Click Here


Single-Pill, Once-Daily HIV Drug Regimen Submitted for FDA Approval
A dual-class, fixed-dose combination pill consisting of efavirenz (Sustiva, Stocrin) + emtricitabine (FTC, Emtriva) + tenofovir (Viread) has been submitted for U.S. Food and Drug Administration (FDA) approval. If the once-daily medication is approved, it will become the first in the United States to contain an entire HAART regimen in a single pill. An FDA decision on the pill is expected later this year. Click Here


Resistance Testing in Treatment-Experienced Patients
The newly revised U.S. HIV treatment guidelines highlight just how central the issue of drug resistance has become in the modern world of antiretroviral therapy. With resistance tests increasingly becoming a routine part of HIV clinical practice, it has grown more important than ever for health care providers to understand how best to apply resistance tests and interpret their results -- particularly for complicated cases, such as treatment-experienced patients. In this article, Andrew Zolopa, M.D., provides an overview and case studies outlining the use and analysis of resistance tests in HIV treatment-experienced patients. Click Here


Adherence Impacted by Age, Support, Regimen Complexity, Swiss HIV Cohort Study Finds
Newly published data from the massive Swiss HIV Cohort Study support some commonly held assumptions about factors influencing antiretroviral adherence: HIV-infected patients who are younger, lack social support or are taking complex regimens are less likely to maintain optimal adherence levels. The results are based on questionnaire responses from 3,607 patients who had been on antiretroviral therapy for at least six months. The questionnaire found that more than 30% of patients reported missing at least one dose in the past four weeks, and that 14.9% of patients missed at least two doses. However, the vast majority of patients -- 92.9% -- still reported adherence levels of at least 95% in the past four weeks. Factors independently associated with nonadherence were younger age, living alone, number of previous regimens, and whether the patient was taking a regimen with a boosted protease inhibitor. The researchers called for greater attention to be paid to the behavioral aspects of HIV in order to improve the likelihood of adherence. Click Here

•  HIV/HAART-RELATED COMPLICATIONS

Late Referrals May Risk Lives of HIV/HBV-Coinfected Liver Transplant Candidates
Research increasingly confirms the safety of liver transplants for many HIV/hepatitis B (HBV)-coinfected patients. In fact, a new University of California-San Francisco study suggests that in some cases, physicians should be referring their coinfected patients for transplants much sooner than they currently do. In the study of 35 HIV/HBV-coinfected patients, only four patients received a liver transplant -- and all four transplants were successful, with the recipients achieving undetectable HBV DNA levels while on prophylactic HBV therapy after more than two years of follow-up. However, many patients died while being evaluated for transplant, and several patients who were not placed on a transplant list died from liver-related events. The researchers suggest that earlier transplant referrals may save the lives of some coinfected patients: "A particular effort should be made to inform physicians caring for HIV patients of the possibility of liver transplantation in this patient population and the importance of a prompt referral to liver transplantation centers," they write. The study was published in the April 2006 issue of Liver Transplantation. Click Here


Abacavir Hypersensitivity: Could a Genetic Test Aid Diagnosis?
Hypersensitivity reaction (HSR) is one of the more severe adverse effects of abacavir (Ziagen). It affects about 8% of patients and tends to manifest shortly after the patient commences abacavir therapy. HSR can cause a range of severe, flu-like symptoms, including sudden fever, vomiting and skin rash. In fact, the symptoms are so flu-like that physicians sometimes have difficulty determining whether abacavir is truly the cause. This can result in a premature, and unwarranted, decision to discontinue use of abacavir. However, Canadian researchers are investigating whether a genetic test might help avoid unnecessary discontinuations: Such a test would look for genetic markers that appear to make a patient much more likely to develop abacavir HSR. Click Here


Cytomegalovirus and HIV
Before the modern HAART era began, cytomegalovirus (CMV) was one of the major causes of illness in HIV-infected patients. Although this opportunistic illness poses only a shadow of the threat it once did (at least in developed countries), it can still be a dangerous and frightening disease for patients with a low CD4+ cell count who are not on treatment. In this detailed overview for HIV InSite, a pair of University of California-San Francisco physicians explains the etiology, diagnosis and treatment strategies for CMV. Click Here


Pregnant Women on PI-Based Therapy Have More Preterm Deliveries
HIV-infected women who take protease inhibitor (PI)-based combination therapy during pregnancy may have an increased risk for preterm delivery, according to a new University of Miami study published in the Journal of Infectious Diseases. The single-site, observational study of 1,337 HIV-infected women found that PI-based therapy appeared to increase the risk of premature delivery by about 80% compared to therapy that did not include a PI. The researchers noted, however, that the mother's health may be a more direct cause of premature delivery, given that pregnant women in the study received PI-based therapy because they had a low CD4+ cell count or had previously failed antiretroviral regimens that did not include PIs. The study also found that antiretroviral therapy class had no statistically significant effect on risk of stillbirth or low birth weight. Click Here


Elevated Blood Pressure More Common Among Patients Initiating Therapy With Lopinavir/Ritonavir, Study Finds
Patients who initiate antiretroviral treatment with a regimen containing lopinavir/ritonavir (Kaletra) are at a greater risk for developing elevated blood pressure, according to the results of a 444-patient U.S. study published in the April 24 issue of AIDS. The Washington University HIV Cohort study found a 2.5-fold greater risk of elevated blood pressure in patients who initiated treatment with lopinavir/ritonavir compared to efavirenz (Sustiva, Stocrin). By contrast, patients initiating therapy with atazanavir (Reyataz) appeared to be most protected from elevated blood pressure, with a risk approximately 80% lower than patients initiating therapy with lopinavir/ritonavir. The researchers noted that the increased blood pressure among lopinavir/ritonavir patients appeared to be mediated by a rise in body mass index after treatment initiation. Click Here


Coinfection With Hepatitis Viruses and HIV
Hepatitis is one of the most common coinfections among HIV-infected patients: Experts estimate that more than a third of all persons with HIV also have hepatitis C, and that between 70% and 90% of HIV-infected people have at some point been infected with hepatitis B. These high prevalence rates reiterate the importance of fully understanding the etiology of these diseases and the challenges that arise when managing coinfected patients. This in-depth resource for health professionals, written for HIV InSite by Mandana Khalili, M.D., of the University of California-San Francisco, provides a detailed, clinical overview of the diagnosis and management of HIV/hepatitis B and HIV/hepatitis C coinfection. Click Here

•  HIV TESTING & PREVENTION

CDC Set to Recommend Voluntary, Routine HIV Testing for All U.S. Residents; New Guidelines Would Promote Oral Consent, Ease Counseling Requirements
The U.S. Centers for Disease Control and Prevention (CDC) reportedly plans to recommend that physicians offer voluntary HIV testing to all U.S. residents ages 13 to 64 as part of routine medical exams in private practices, clinics, hospitals and emergency departments. In a further effort to remove barriers to HIV testing, the agency also reportedly plans to recommend revising current guidelines that require patients to sign informed-consent forms before receiving an HIV test and removing or condensing the requirements for pretest counseling. The revised HIV testing guidelines are expected in June or July. Click Here


All Hospitalized Patients Should Receive Routine HIV Testing, Study Suggests
Should all patients admitted to hospitals be routinely tested for HIV? A recent U.S. study suggests that doing so could help a large number of previously undiagnosed HIV-infected individuals. The 243-person study found that patients who tested positive during routine testing after being hospitalized generally had a lower CD4+ cell count and a higher viral load than outpatients. The study noted that half of the inpatients who tested positive during routine HIV testing would never have been diagnosed if the testing policy had not been in place, putting their future health in danger. Click Here

In this related editorial, noted physician/researcher Judith Feinberg, M.D., writes that it is long past time for the United States to expand its use of HIV testing. She points out that there are still an estimated 250,000 Americans who have HIV and do not know it, thus fueling the continued spread of the virus. "By involving physicians and other health care professionals more intensively in testing and prevention efforts, it is hoped that the health care professional-patient bond will have a greater influence on stemming the epidemic," Dr. Feinberg says. She also suggests that more widespread testing may be the only way the United States can begin to bridge the widening racial gap in HIV rates.


Highlights From the Microbicides 2006 Conference
In April, researchers and advocates gathered in South Africa for the world's largest conference on microbicides. The conference ended with an impassioned plea to the world's political leaders and drug companies to provide better funding and support for microbicide development, which has received only a limited amount of official backing to date. The aim of the conference was to review the world's progress in producing microbicides, which have been in development for 15 years. Read this article for a summary of conference highlights. Click Here


Microbicides Aren't All About the Vagina, Advocacy Group Says
Most of the research on HIV microbicides has focused on their vaginal use. But many AIDS advocates are quick to point out that rectal microbicides desperately need attention and funding, too. In a recent report, the International Rectal Microbicide Working Group points out that rectal microbicides can benefit men and women alike. After all, the report states, in some parts of the world up to 30% of heterosexuals are having anal intercourse. Click Here

•  HIV EPIDEMIOLOGY

Most HIV-Infected Male Inmates Don't Get Infected in Prison, Report Finds
HIV transmission may not be nearly as common in prison as some have long presumed: A new report has found that about 91% of HIV-infected men incarcerated in Georgia's prisons last fall had been infected with the virus before they were imprisoned. The report says that just 88 men who had tested negative when they entered prison later tested positive while still in prison. These HIV-infected men were about 13 times as likely as HIV-uninfected inmates to have been tattooed, and about 10 times as likely to have had sex with another man in prison -- often with a prison staff member, and usually consensually. Although federal health officials have recommended distributing condoms and needle-cleaning bleach to inmates -- steps that the inmates themselves have requested -- a Georgia correctional official said the state is not considering the proposal. The state is considering segregating HIV-infected inmates from HIV-uninfected inmates, however. Click Here

To read the full Georgia prison report, click here.


HIV Superinfection: A Look at the Evidence
Can an HIV-infected individual be concurrently infected with two different strains of HIV? Research shows that such superinfection (variously called reinfection or dual infection) is possible, but appears to be quite rare. The medical community still has much to learn about why or how superinfection occurs -- and what impact it might have on a patient's prognosis and treatment options. In this detailed review, Nicholas Cheonis of San Francisco AIDS Foundation takes a closer look at the superinfection enigma. Click Here


Large Drop in HIV Diagnoses Among MSM in San Francisco; Officials Consider Lowering Estimates
San Francisco's HIV incidence rate among men who have sex with men (MSM) has dropped by almost a half in the last four years, according to a U.S. Centers for Disease Control and Prevention study released in June 2005. As a result, San Francisco health officials may cut the city's official incidence estimate. A draft recommendation proposes that the official annual HIV rate for the city be lowered from 1,084 to 976 -- with 87% of those new infections occurring among MSM. "It hasn't changed that much," admitted Dr. Willi McFarland, an epidemiologist who works for the city health department. "[B]ut the fact is, we've reversed a trend." Click Here

•  HIV NEWS & VIEWS

Many ADAPs Overpay for HIV Meds, Report Finds (PDF)
At the same time that some U.S. AIDS Drug Assistance Programs (ADAPs) are putting patients on antiretroviral waiting lists because of funding shortages, many ADAPs are unwittingly being overcharged for the antiretrovirals they purchase, a new report has found. The report, written by the U.S. Government Accountability Office, took an in-depth look at how each of the country's 52 ADAPs are organized and funded, as well as how they pay for their antiretrovirals. Investigators found some unsettling results: For instance, a mind-boggling 49 of 52 ADAPs reported paying a higher price than they were supposed to for at least one antiretroviral (and often many more). The report also noted that of the 10 most commonly prescribed antiretrovirals, Delaware's ADAP overpays for all of them, while Oklahoma's ADAP overpays for nine and Kentucky's ADAP overpays for eight. The report blames inadequate reporting and a lack of government oversight for the problems. Click Here


AIDS at 25: How Has the Virus Changed Us?
Many people will be looking back this year as the AIDS epidemic turns 25. Timothy Murphy, Ph.D., head of the medical humanities department at University of Illinois College of Medicine, has written prolifically about AIDS and ethics. In this essay in the Bioethics Forum, he offers an eloquent view of the past quarter-century. He writes: "The [AIDS] epidemic threw American identity and national dogmas into question: We were not one indivisible community, sharing the same social status, rules, and opportunities. We were not all heterosexual adults, faithful in marriage, abstinent outside marriage, immune to the lure of drugs, with the same access to health care. The epidemic told a very different story, and some social authorities were on edge, fearful to accommodate AIDS on its own terms, for what that meant about who 'we' were. Political fissures undermined a unified front against the epidemic from the very beginning." Click Here


Getting It Right: Being Smarter About Clinical Trials
Most researchers know first-hand how challenging it can be to conduct a "perfect" clinical trial. Small errors in construction, execution and analysis can accidentally introduce potential bias, limiting the relevance of the findings. In addition, the manner in which study findings are communicated can easily result in their misinterpretation by the general public. What can researchers do to remove as much bias as possible from clinical trials, and ensure a better understanding of the results? The U.S. National Institutes of Health set out to find the answers in a recent meeting. This detailed article summarizes the recommendations that came out of this major discussion among researchers. Click Here


FDA Says It Does Not Support Use of Medical Marijuana
In a decision that advocates and some clinicians immediately denounced as politically motivated, the U.S. Food and Drug Administration (FDA) has released a statement saying it does not support the medical use of marijuana. The statement contradicts a government report seven years ago that found valid medical uses for marijuana, including the relief of nausea and pain from complications such as AIDS-related wasting syndrome and peripheral neuropathy. "There is clearly no scientific logic to their decision," said Greg Carter, M.D., a rehabilitation-medicine specialist at the University of Washington. Although the FDA says in its statement that there are no data to support medical marijuana use, the federal government has never approved funding for a large clinical trial to conclusively assess marijuana's effectiveness as a medical treatment. Click Here

To read the official FDA statement on medical marijuana, click here.

•  HIV OUTSIDE THE UNITED STATES

HIV and Hepatitis in Europe: Border Crossings and Buried Bombs
It's easy to assume that Western Europe and North America have similar HIV epidemics -- after all, they are two of the world's richest regions, where access to HIV treatment and good medical care is more the rule than the exception. But Western Europe's epidemic is a very different beast, in large part because so many HIV-infected people emigrate from nearby countries in Eastern Europe and Africa, where HIV incidence is high. In this captivating summary of the most recent IAPAC European Sessions conference, Mark Mascolini discusses the driving forces behind the HIV epidemic in Western Europe, and identifies the steps some researchers have proposed to stem it. He also reviews research on lipodystrophy, antiretroviral adverse events and new antiretrovirals. Click Here


U.S. HIV Physician Treats Female Survivors of Rwandan Genocide
During the 1994 genocide in Rwanda, hundreds of thousands of women were raped. "An estimated 67% of survivors now have HIV, some deliberately exposed to the virus via rape as a 'slow poison' by the genocide perpetrators -- the first historic use of HIV as a weapon of war," says Mardge Cohen, M.D., of Cook County Hospital in Chicago, one of the foremost researchers on HIV in women. Dr. Cohen is part of a U.S.-based organization that has set up clinics in Rwanda to provide HIV testing, treatment and support to women and children. Helping these people is "a matter of justice," Dr. Cohen says in this interview. She notes that in 2003, many of the rapists were receiving free HIV medications in jail, while their victims had no access to treatment. Click Here


Economist Examines Progress of WHO's 3 by 5 Initiative
Although the World Health Organization (WHO)'s 3 by 5 Initiative badly missed its "absurdly optimistic" target of treating three million HIV-infected persons in developing countries by the end of 2005, the initiative "may have been more successful than the headline figure suggests," the Economist reports in its March 30 issue. One of the main challenges the 3 by 5 Initiative faced was the lack of infrastructure needed to provide wide-scale access to antiretrovirals in most countries. However, the initiative can still be considered at least a partial success because some of its funding has gone toward building needed infrastructure, including clinics, laboratories and training for health care workers, according to the Economist. Click Here


HIV Ravages Central America as Epidemic Evolves
Four of the five Latin American countries with the highest HIV prevalence are in Central America. In Honduras, with a population of around 7 million, officials estimate prevalence at 1.8%, though epidemiologists say the real figure could be much higher. In the early stages of the epidemic, Honduran men accounted for the majority of the country's HIV cases. Now, almost half are women. "The epidemic is two steps in front of us," said Kenneth Rodriguez, a Honduran epidemiologist and AIDS expert who works for UNICEF. "We need to take extreme measures to slow it down." Click Here