•  HIV TREATMENT & CARE

New HIV Treatment Guidelines in Europe Recommend HAART Initiation at 350 Cells/mm³
The drive to initiate antiretroviral therapy earlier in HIV-infected patients has officially hit a new milestone: New European HIV treatment guidelines recommend that health care providers begin treating a patient when his or her CD4+ cell count drops below 350 cells/mm³. It is widely expected that, when new U.S. guidelines are issued within the next few months, they will follow suit.

Click here to download the revised European guidelines, which also include new guidance regarding the goals of antiretroviral therapy, the management of HIV/hepatitis-coinfected patients and the management of metabolic complications.


Lopinavir/Ritonavir Monotherapy Requires Strict Adherence, Studies Say
New data from France and Spain indicate that HIV-infected patients can achieve viral suppression on lopinavir/ritonavir (Kaletra) monotherapy, but that success depends largely on strict treatment adherence. The French study also noted found that patients with HIV subtype B (which is predominant in the developed world) were considerably more likely to achieve virologic suppression on lopinavir/ritonavir monotherapy than their non-type-B counterparts.


Amprenavir Removed From U.S. Market
It was only a matter of time before the curtain officially came down on amprenavir (Agenerase), and now it is official: GlaxoSmithKline discontinued the sale of the drug in the United States as of the end of October. The news is not surprising, given that demand for the drug has dropped steadily since a reformulated version, fosamprenavir (908, Lexiva, Telzir), was approved in 2003.


Significant Lag Remains Between HIV Diagnosis and Onset of Care, Baltimore Study Finds
HIV-infected patients today are generally not waiting as long after their diagnosis to seek medical care as patients did in 1990 (when antiretroviral therapy was virtually nonexistent), but their CD4+ cell count during their initial visit is lower than that of patients in 1990, according to the results of a study by Johns Hopkins University researchers. The long-term study of 3,300 patients presenting at the Johns Hopkins AIDS Service found that the average time between HIV diagnosis and seeking care dropped from 271 days during the 1990-1994 period to 196 days in the 2004-2006 period. However, the median CD4+ cell count of patients at initial presentation also dropped, from 371 cells/mm³ to 276 cells/mm³. The worrisome findings led the researchers to recommend new strategies to ensure earlier testing and referral to care for HIV-infected individuals.

•  HIV/HAART-RELATED COMPLICATIONS

Study Suggests Experimental Drug Can Reduce Abdominal Fat in HAART Patients
A growth hormone releasing factor drug in development called tesamorelin (TH9507) appears to reduce visceral fat in HIV-infected patients who experience fat gain while on antiretroviral therapy, according to newly presented data. Patients taking tesamorelin for 52 weeks experienced an 18% reduction in visceral fat relative to baseline, and a 3.25-cm reduction in waist circumference. Adverse effects were quite common, however, with arthralgia occurring most frequently; in addition, the beneficial effects of tesamorelin appeared to quickly dissipate upon treatment discontinuation.

Earlier this year, Steven Grinspoon, M.D., the principal investigator of the group studying tesamorelin, discussed the 26-week, interim study results on the drug. Click here to read or listen to his explanation of those results.


Is a New Generation of HCV Treatment Near?
Standard hepatitis C (HCV) treatment is known to cause a range of potentially significant adverse effects, and it does not hold a candle to first-line HIV therapy in terms of efficacy. That is why it is such welcome news to hear that not one, but two HCV drugs in development impressed attendees of the recently concluded annual meeting of the American Association for the Study of Liver Diseases. Each of the drugs, nitazoxanide (Alinia) and telaprevir (VX-950), appears to increase the rate of sustained virologic response when coadministered with current HCV standard-of-care therapy.

These experimental HCV drugs, along with a flurry of recent studies, have propelled HCV research forward after a long period of stagnancy. This article from aidsmap.com summarizes other recent research, the results of which drive home the importance of testing and treating patients for HCV before liver disease is allowed to progress.


HIV and TB in the United States: Updated Epidemiological Data
Tuberculosis (TB) is the leading cause of death among HIV-infected people worldwide, and though it mostly impacts individuals in the developing world, patients in the United States are at risk for infection. As this report from the U.S. Centers for Disease Control and Prevention discusses in detail, there is a 13% HIV prevalence rate among TB patients in the United States whose HIV status is known. A large proportion of U.S. patients with TB do not know their HIV status.

•  MENTAL HEALTH/QUALITY OF LIFE

A Guide to Helping Patients Deal With Anxiety
Up to 70% of HIV-infected patients report persistent symptoms of anxiety, and up to 40% of patients meet the criteria for an anxiety disorder. Therefore, knowing how to handle anxiety is helpful for health care providers who treat HIV-infected patients. In this article, Joni Lavick, M.F.T., and Gaetano Vaccaro, Ph.D., provide an overview of the social, personal and biological causes of anxiety in people with HIV, and review the medications and therapies used to treat it.

•  PREGNANCY & PEDIATRICS

FDA Approves Lopinavir/Ritonavir Tablets for Children
A lower-dose, pediatric tablet formulation of lopinavir/ritonavir (Kaletra) has received approval from the U.S. Food and Drug Administration (FDA). The approval follows a warning issued in August that urged health care providers to be cautious in prescribing liquid lopinavir/ritonavir to children after the death of an infant who was accidentally administered an overdose of the liquid solution. The 100-mg lopinavir/25-mg ritonavir tablet formulation allows for storage without refrigeration and comes with no food requirements.


Standard HIV Testing May Miss Women Infected During Pregnancy, Study Warns
Researchers from North Carolina warn that routine HIV testing of pregnant women in the United States might miss infections that occur during pregnancy. In a study published in the November issue of AIDS, the researchers pointed out that standard antibody testing may fail to detect recent HIV infections among pregnant women. The researchers recommend using nucleic acid testing instead; though the process is more complicated and more expensive, it is also more likely to detect recently transmitted HIV, they say.


U.S. Updates HIV Treatment Guidelines for Pregnant Women
The U.S. Department of Health and Human Services has released updated recommendations for the treatment of HIV-infected pregnant women. The new document features a full reorganization of treatment recommendations, and includes a number of revisions, among them: the addition of nelfinavir (Viracept) to the list of antiretrovirals that are not recommended for use in pregnant women; updated guidance regarding the management of HIV-infected women coinfected with hepatitis B and hepatitis C virus; and new information regarding the pharmacokinetics and toxicity of several antiretrovirals in pregnant women.


Number of HIV-Infected U.S. Infants Down Dramatically, but Less So Among Minorities
In 2005, 111 infants born in the United States tested positive for HIV, according to a study by the U.S. health department. The incidence rate is just one third of the 1994 rate, which speaks to the success of routine HIV testing and to more effective management of HIV in women during and after pregnancy. However, the number of HIV infections among Hispanic and African-American infants has fallen more slowly than among whites: 80% of the infants who tested positive in 2005 were African American or Hispanic.

To read an official summary of this report, click here.

•  HIV/STD TRANSMISSION

HIV Vaccine Trial Participants Warned About Possible Increased HIV Infection Risk
In the wake of the failure of its experimental HIV vaccine, Merck & Co. has unblinded the international study, and is warning participants who received the vaccine that it may have increased their HIV risk. The vaccine trial was halted earlier this year when an interim review revealed that the vaccine not only failed to prevent HIV infection, but may have even made patients more susceptible to HIV infection if they had a pre-existing immunity to the adenovirus used to deliver the vaccine.


Four Chicago Transplant Recipients Contract HIV, Hepatitis C
For the first time in more than 20 years, U.S. patients have been infected with HIV as a result of an organ transplant. Four transplant recipients in Chicago received organs from a single person who was coinfected with HIV and hepatitis C, but who had been infected so recently that the organs tested negative for both viruses on standard antibody tests. As a result of the infections, pressure may increase to use more sensitive (and more expensive) nucleic acid screening on donated organs.

•  HIV IN THE NEWS

Walgreens and Other Major U.S. Pharmacies Sue Over Ritonavir Price Increase
Four years after drug maker Abbott Laboratories caused an uproar after quadrupling the price of ritonavir (Norvir), some of the United States' biggest pharmacy chains are fighting back. Four national pharmacy chains, including Walgreens, and one pharmaceutical wholesaler have filed a lawsuit accusing Abbott of unlawfully extending its monopoly on ritonavir when, in 2003, it increased the wholesale price of a standard 100-mg daily dose of ritonavir from a little over $50 per month to more than $250 per month.

Shortly after Walgreens et al filed their suit, GlaxoSmithKline followed with a lawsuit of its own. Glaxo alleges that Abbott's actions were an illegal attempt to price out of the market competing ritonavir-boosted combinations, including Glaxo's drug fosamprenavir (908, Lexiva, Telzir), by increasing the price of ritonavir without also raising the cost of Abbott's own ritonavir-boosted combination, lopinavir/ritonavir (Kaletra).


HIV May Have Arrived in U.S. From Haiti in 1960s, Research Suggests
HIV has been in the United States since as early as 1966, according to a new study. Based on frozen blood samples, a team of U.S. researchers traced a new timeline for the arrival of HIV in the United States. The scientists now believe the virus first made its way from the Democratic Republic of Congo to Haiti in the 1960s, and then came to the United States when a Haitian immigrated to a large U.S. city in the late 1960s or early 1970s -- about a decade earlier than previously believed.

Many in Miami's Haitian community have expressed concern that the study findings could fuel discrimination against Haitians. However, researchers have expressed hope that the study could help foment a deeper understanding of the virus, potentially leading to new avenues for vaccine development.

•  HIV OUTSIDE THE UNITED STATES

Adding Tenofovir + Emtricitabine to Single-Dose Nevirapine Cuts Resistance Risk for Pregnant Women
HIV-infected pregnant women in developing countries are often administered a single dose of nevirapine (Viramune) during labor to prevent vertical HIV transmission. However, many experts have raised concerns that single-dose therapy could breed drug resistance, reducing these women's future HIV treatment options. A new study published in the Nov. 17 issue of The Lancet recommends adding single doses of tenofovir (Viread) and emtricitabine (FTC, Emtriva) to the nevirapine dose; the combination appears to greatly reduce the risk of drug resistance.