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Friday, December 16, 2011

Rumors of HIV in Pepsi Debunked in India

A text message circulating that Pepsi products have been contaminated with HIV is untrue, Asia One reports.

The text message, which originated in India in July, states that a worker from the company purposely contaminated Pepsi products with samples of HIV-positive blood. Officials from Pepsi have said the text is absolutely a hoax, they outlined the company’s hands- free production process, and had have pointed to the Centers for Disease Control and Prevention, which has said that the virus is short lived outside the body and poses no risk even if consumed in a manner described in the hoax.

To read the Asia One article, visit: http://www.asiaone.com/Health/News/Story/A1Story20111205-314378.html.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!

Headaches, Migraines Common in People Living With HIV

Headaches affect one in two HIV-positive people, with more than one in four people living with the virus experiencing chronic migraines, according to a new University of Mississippi research paper published ahead of print in the medical journal Headache.

“This research is of interest for several reasons,” Todd Smitherman, PhD, noted in an accompanying press release. “Recent research from the U.S. Centers for Disease Control and Prevention shows that, despite the availability of medications that effectively slow disease progression, most Americans with HIV do not have the disease under control. Our study shows that patients with poorly controlled HIV/AIDS are most prone to suffer also from frequent, severe migraines at rates that far exceed those of the general population.”

The objective of the study, conducted by Smitherman and his colleagues, was to characterize headache symptoms among people living with HIV and to assess the associations between headaches and various HIV disease variables, such as CD4 cell count, viral load, length of HIV infection and use of antiretroviral (ARV) therapy.

Two hundred people living with HIV averaging 43 years old—49 percent were female, and 74 percent were African American—from an internal medicine clinic and an AIDS outreach clinic participated in a diagnostic interview and two pain-related disability assessments to evaluate and define headache characteristics and related features that are consistent with established medical classifications. The study was cross-sectional in design, meaning that volunteers were asked to recall their current or past headache symptoms, along with their HIV medical histories, during the interview and assessment visit.

According to the study’s results, 107 (53.5 percent) of the HIV-positive interview subjects reported headache symptoms. Unfortunately, the researchers did not employ a control group—consisting of demographically matched HIV-negative individuals—thus the study was not able to conclude that headache symptoms are necessarily more common among people living with HIV.

However, Smitherman and his colleagues noted that many of the headaches reported were “not your typical, run-of-the mill tension headaches.” About 27.5 percent of the study volunteers met criteria for “chronic migraine,” a rare headache condition in which a person has migraine symptoms—intense, pulsating and throbbing head pain; sensitivity to light; nausea and vomiting; blurred vision; etc.—for 15 or more days per month. In comparison, the authors suggest, only 2 percent of the general population is classified as having chronic migraines.

Severity of HIV disease—as indicated by CD4 cell counts—but not duration of HIV or number of prescribed ARV medications, was strongly associated with headache severity, frequency and disability. HIV severity also distinguished migraine from tension-type headaches. Whether there was an association between specific ARVs and headaches was not reported by the researchers.

“Problematic headache is highly prevalent among patients with HIV/AIDS, most of which conform to the [criteria] of chronic migraine,” the authors conclude. “A low frequency of identifiable secondary causes”—notably AIDS-related diseases of the central nervous system—“is likely attributable to reduced frequency of opportunistic infections in the current era of [combination ARV therapy],” they add. “Disease severity is strongly predictive of headache, highlighting the importance of physician attention to headache symptoms and of patient adherence to treatment.”

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!

Novel HIV-Associated Diarrhea Drug Crofelemer Goes to FDA for Approval Review

Raleigh, North Carolina-based Salix Pharmaceuticals announced on Tuesday, December 14, that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approved for Crofelemer, a novel therapy for HIV-associated diarrhea.

Modern antiretroviral (ARV) medication has dramatically improved the lives and health of people with HIV. Not only are the rates of diseases that cause chronic diarrhea a fraction of what they once were, but most medications that once caused or worsened diarrhea are no longer commonly used.

However, according to Salix and the drug's primary developer, Napo Pharmaceuticals, thousands of HIV-positive people in the United States and millions of people in other parts of the globe still struggle with chronic diarrhea. What’s more, the condition can be more than merely unpleasant—it can have serious health consequences, including dehydration and the loss of life-sustaining nutrients from the body. Unfortunately, current remedies for diarrhea can have side effects and none of the meds were meant to be taken constantly for weeks or months at a time.

Crofelemer—which is based on a plant native to South America and is being sustainably harvested by growers there—acts by a different mechanism than current anti-diarrheal medications. Rather than being taken up systemically into the whole body, it acts locally in the gut and helps regulate the amount of water in the intestines. It also doesn’t interact with other medications.

The NDA filed by Salix includes data from a Phase III clinical trial dubbed the ADVENT study. The trial first pitted three doses of Crofelemer against a placebo for four weeks in 50 people with chronic watery diarrhea. Once data from the first round were collected, 180 additional people were randomized to receive either the selected dose (125 milligrams twice daily) or a placebo.

Though the full data have not yet been presented, Napo reported in November 2010 that the selected dose reduced diarrhea to less than two watery stools for two weeks of a four-week period—a significant reduction compared with the placebo.

By regulation, the FDA has 60 days from the date of the NDA submission to conduct a filing review to determine if the application is sufficiently complete to permit a substantive review.

If the drug is ultimately approved, Salix, after entering into a collaboration agreement with Napo, has an exclusive license to the HIV-associated diarrhea indication for Crofelemer and the additional indications of pediatric diarrhea and acute infectious diarrhea in North America, several Europe countries and Japan. Salix also has a worldwide license to all other possible human indications, including irritable bowel syndrome, for Crofelemer.

Napo has purported to terminate the license due to Salix's alleged failure to develop Crofelemer and other alleged breaches of the collaboration agreement. According to Salix, however, Napo's purported termination of the license is groundless and without merit.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!

Gilead Seeks FDA Approval for Truvada PrEP

Gilead Sciences has filed an application with the Food and Drug Administration (FDA) to approve its combination drug Truvada (emtricitabine and tenofovir) as pre-exposure prophylaxis (PrEP) therapy for men who have sex with men (MSM) and heterosexual men and women at risk of becoming infected with HIV.

Truvada is to be taken once a day, every day, regardless of whether you’re sexually active that day.

The application for approval uses data from the Iniciativa Profilaxis Pre Exposicion, or iPrEx, study—a clinical trial that examined the effects of PrEP on HIV transmission among MSM.

According to the study's results, Truvada PrEP resulted in 44 percent fewer infections among MSM who used the drug, compared with those who used a placebo. Among participants who were more adherent, the rate of protection was more than 90 percent. (Participants also received condoms and HIV prevention support; the benefits of PrEP were in addition to these HIV prevention benefits.)

An equivalent study among close to 5,000 serodiscordant heterosexual couples in Uganda and Kenya showed similar results, and an Open Label Extension of the iPrEx study is underway to provide long-term information on PrEP’s long-term health effects.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!

Diabetes Med Glucophage and Diet/Exercise Changes Improve Cardio Risks in HIV

People living with HIV and metabolic syndrome who combined the diabetes drug Glucophage (metformin), both with and without dietary changes and exercise, may be able to stave off signs of cardiovascular disease (CVD), according to a new research paper published online ahead of print in the journal AIDS.

CVD, including “sub-clinical” signs of the disease such as plaque buildup in arteries (atherosclerosis), is increasingly common among people living with HIV. A likely reason for this is an increased rate of metabolic syndrome—a combination of diabetes, high triglyceride and cholesterol levels, elevated blood pressure and/or abdominal obesity—among HIV-positive people, including those using antiretroviral therapy.

Dietary changes and exercise have long been considered to be important elements of CVD prevention and management, though their benefits in preventing plaque buildups in the arteries and other important cardiovascular health markers aren’t well understood.

Similarly, while drugs such as Glucophage have been shown to significantly reduce CVD-related complications in overweight HIV-negative people with diabetes, they haven’t been well studied in people living with HIV, particularly those not already using medications for diabetes.

Fifty people living with HIV with metabolic syndrome were recruited for the study, conducted by Kathleen Fitch, NP, and her colleagues at Massachusetts General Hospital in Boston. The study volunteers averaged 46 years of age at study entry; CD4 counts were between 406 and 691 in the four groups; just less than half were cigarette smokers; and most participants in the study had undetectable viral loads.

Four groups were compared in the study. The first group treated patients with 500 milligrams (mg) of Glucophage twice daily, with dose increased up to 850 mg twice daily, without any dietary or exercise interventions. The second group received dietary guidance and structured exercise training, but not Glucophage treatment. The third group received both Glucophage and diet/exercise modification training. The fourth group received neither intervention.

Measures of coronary artery calcification (CAC)—a marker of artery-blocking arteriosclerosis—and cardiovascular fitness were conducted at various time points in the study.

According to Fitch’s group, Glucophage-treated patients demonstrated significantly less progression of CAC than those who received placebo of diet/exercise changes alone. Lifestyle changes did not prove to slow progression of CAC, statistically speaking, though there did appear to be a trend toward more calcification buildup among those who didn’t undergo either Glucophage treatment or diet/exercise modifications.

The only group in which there appeared to be an improvement in CAC—not simply slowed progression—involved patients receiving both Glucophage and diet/exercise modifications. While this reduction was statistically significant when compared with those who didn’t receive any intervention, it was no statistically significant when compared with data involving those who received Glucophage alone.

There were some important and statistically significant benefits associated with lifestyle modifications alone. These included improvements in “good” HDL cholesterol levels, high sensitivity C-reactive protein (an inflammatory marker associated with CVD) and cardiovascular and respiratory fitness. Conversely, Glucophage treatment had no affect on these markers.

“[This] study is the first to demonstrate the potential utility of metformin to prevent a very significant, progressive increase in the calcified plaque progression among HIV-infected patients with metabolic syndrome,” Fitch and her colleagues conclude. “Lifestyle management and training was effective to increase fitness and improve selective metabolic indices, but did not prevent progression of atherosclerosis as much as metformin. Further studies are now needed to understand the mechanisms of metformin to prevent calcified plaque progression and to determine whether metformin, alone or in combination with other strategies, might reduce or prevent CVD events in this population.”

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!

Animal Studies Suggest Anti-Reservoir Drugs May Help 'Functionally Cure' HIV

Drugs targeting HIV reservoirs in the body may result in spontaneous control of viral replication, in the absence of antiretroviral (ARV) therapy, according to a new study involving 18 monkeys conducted by Andrea Savarino, MD, PhD, of the Istituto Superiore di Sanità in Rome and his colleagues. The new findings, among the most noteworthy at an HIV eradication conference recently held in St. Maarten, in the Caribbean, could prove highly useful as researchers continue exploring ways to functionally cure HIV infection.

Though much attention is being paid to efforts to achieve sterilizing HIV cures—those akin to what was achieved in Timothy Brown, the “Berlin Patient,” who underwent high-dose chemotherapy and two stem cell transplants to render his immune system impervious to HIV and essentially snuff the virus out completely—there are also proposed strategies to achieve functional HIV cures. With a functional cure, HIV remains detectable in the human body, but no viral replication is found in the absence of ARV therapy.

Typically, discontinuing ARV therapy leads to a rapid rebound in viral load, likely because HIV persists in a large number of long-lived cellular reservoirs in the body that are not affected by standard medications. Some researchers believe that the immune system does have the ability to keep viral replication in check, but that the high volume of HIV that returns following ARV treatment discontinuation quickly overwhelms the immune system. In turn, some scientific teams have been interested in pairing drugs that attack cellular reservoirs of HIV with standard ARV therapy, to see if they can blunt the proliferation of virus following treatment discontinuation and therefore provide the immune system with an opportunity to maintain control of the virus on its own.

Researchers such as David Margolis, MD, at the University of North Carolina in Chapel Hill are studying HIV reservoir-targeting therapies in human subjects. Meanwhile, there is much to be gained from exploring similar approaches in animal models, notably macaques infected with SIV, HIV’s simian counterpart.

The experiments conducted by Savarino and his colleagues involved 18 SIV-infected macaques receiving ARV therapy and, in some cases, drugs targeting long-lived SIV reservoirs. Five macaques in particular received ARV therapy in combination with auranofin—an approved medication, sold under the brand name Ridaura, used to treat rheumatoid arthritis and previously shown to be capable of killing memory CD4 cells (a major long-lived HIV reservoir)—and the glutathione synthesis inhibitor buthionine sulfoximine (BSO), which has been shown to help eliminate HIV-infected cells.

After a series of treatment cycles combining ARV therapy first with auranofin and then with BSO, extremely low viral “set points”—viral loads below 200 copies in the absence of treatment—were maintained for more than 100 days in three of the macaques.

“The change in viral load set point was positively correlated with the number of drugs potentially acting against the viral reservoir that the monkeys had received,” Savarino and his colleagues wrote in the study abstract, “thus suggesting that drugs acting against viral targets alone”—such as antiretrovirals—“are insufficient to induce viral load containment in the absence of therapy.

“The results of the present study,” the authors conclude, “show that anti-reservoir strategies may indeed result in spontaneous control of viral load in the chronic phase of the infection and pave the way to a functional cure for AIDS.”

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!

Thursday, December 15, 2011

Alcohol Consumption and the Intention to Engage in Unprotected Sex

To assess whether alcohol could have an independent effect on incidence of HIV/STIs, the authors conducted a systematic review and meta-analysis of randomized controlled studies that examined the association of blood alcohol content (BAC) and self-perceived likelihood of condom use during intercourse. The meta-analysis included an estimate of dose-response effect, tests for publication bias, and sensitivity analyses.

For the 12 studies included in the pooled analysis, an increase in BAC of 0.1 mg/ml resulted in an increase of 5.0 percent (95 percent confidence interval: 2.8-7.1 percent) in the Likert scale-indicated likelihood of engaging in unprotected sex. Adjusting for potential publication bias, the estimate dropped to 2.9 percent (95 percent CI: 2.0-3.9 percent)

“Thus, the larger the alcohol intake and the subsequent level of BAC, the higher the intentions to engage in unsafe sex,” the researchers reported. “The main results were homogenous, persisting in sensitivity analyses and after correction for publication bias.”

“Alcohol use is an independent risk factor for intentions to engage in unprotected sex, and as risky sex intentions have been shown to be linked to actual risk behavior, the role of alcohol consumption in the transmission of HIV and other STIs may be of public health importance,” concluded the authors.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!