The study authors noted that the rate of low muscle mass was similar to that found for HIV-negative men aged 70 to 74 years old in a different study.

The investigators suggested that evaluation for muscle loss should be included when assessing bone fracture risk in people with HIV. They stressed the need for future studies that examine the impact of decreased muscle mass and function on physical wellness and quality of life for people with HIV.

Previous studies have suggested that premature aging, including changes in the muscle, bone, and nervous systems, are common in people with HIV. Some researchers believe HIV itself causes premature aging in people with the disease; there are also indications that some antiretrovirals, including older drugs such as zidovudine (Retrovir) and stavudine (Zerit), may be responsible for premature aging (see related AIDS Beacon news).

Sarcopenia is the loss of muscle mass, strength, and function associated with aging. According to the study authors, multiple factors, including poor nutrition, inflammation, and hormonal changes, are thought to contribute to age-related muscle loss. Disability, hospitalizations, increased risk of falls, lower quality of life, and increased risk of death are some possible outcomes of the disease.

The study authors noted that screening for sarcopenia is relatively easy and can be done with muscle function tests, including gait speed and balance tests.

In this study, investigators examined the rate of age-related muscle loss and potential risk factors for the condition, including low muscle mass, low bone mineral density, and lipodystrophy (abnormal body fat redistribution), in HIV-positive men.

The study included 66 men with HIV with a median age of 42 years old. About 14 percent of the men were previously untreated; the rest were treatment-experienced. On average, the previously treated men were about 10 years older, had HIV longer, and had lower CD4 nadir counts (the lowest CD4, or white blood cell, count measured after infection) than treatment-naïve men.

Results showed that 19 percent to 22 percent of the men had low muscle mass, and 68 percent had low bone mineral density. In addition, between 42 percent and 55 percent of the men had lipodystrophy.

There was no difference in the frequency of low muscle mass or low bone mineral density in previously treated versus treatment-naïve men. Low muscle mass and low bone mineral density were both associated with a lower body mass index.

Men with low bone density were also more likely to have been treated with non-nucleoside reverse transcriptase inhibitors and drugs such as zidovudine or stavudine.

Lipodystrophy was highly associated with antiretroviral therapy, including treatment with protease inhibitors and nucleoside reverse transcriptase inhibitors. However, lipodystrophy was less common in men with low muscle mass.

For more information, please see the study in the Journal of Clinical Densitometry (abstract).

The study authors also noted that participants with the most severe limb fat loss had the largest gain in limb fat after switching.

“This is good news for participants with severe loss of limb fat, as switching treatment can positively change their body image,” said Allison Humphries, Senior Clinical Project Coordinator at the Kirby Institute of the University of New South Wales, Australia and the lead author of the study.

“We are currently finalizing a publication looking at the changes in bone markers for the same study. This is to assess the effect of switching to Epzicom or Truvada on bone mineral density,” added Humphries.

Lipodystrophy is characterized by abnormal body fat redistribution, such as loss of fat from the arms and legs and build-up of fat in the abdomen. People with lipodystrophy also commonly suffer from metabolic syndrome, which is a syndrome that includes insulin resistance, high cholesterol levels, high blood pressure, and higher risk for type 2 diabetes and heart attacks.

Lipodystrophy and metabolic syndrome are common side effects of certain antiretrovirals. In particular, protease inhibitors and older nucleoside reverse transcriptase inhibitors (NRTIs), such as zidovudine (Retrovir), stavudine (Zerit), and didanosine (Videx), are linked with significant body fat redistribution and metabolic changes.

Previous research has shown that lipodystrophy can result in serious psychological problems and stigma, eventually leading to treatment non-adherence.

According to the study authors, changing therapy from older NRTIs to newer ones such as Ziagen (abacavir) or Viread (tenofovir) has been shown to help with the gradual recovery of fat that was lost due to treatment in people with HIV, particularly in those with severe cases of lipoatrophy (fat loss in the arms and legs).

In this prospective study, the investigators examined factors that might predict changes in the amount and distribution of limb fat (fat in the arms or legs) in people who switched from older NRTIs to Truvada (emtricitabine/tenofovir) or Epzicom (abacavir/lamivudine).

The study included 303 participants on antiretroviral therapy who had undetectable viral loads (amount of HIV virus in the blood). The average participant age was 45 years old. Most participants were male (98 percent) and Caucasian (86 percent). The average length of HIV infection was 10 years.

Study participants were randomly assigned to switch to either Truvada or Epzicom. Researchers then monitored their body fat levels and other factors such as cholesterol and blood glucose levels over a period of 96 weeks.

Results showed that patients in both treatment groups had an average increase in limb fat of 7 percent by week 48 and 13 percent by week 96. However, these gains were considered clinically moderate, meaning that patients were still classified as having lipoatrophy.

Overall, 51 percent of patients experienced a 10 percent or greater gain in limb fat during the study, and 35 percent had a 20 percent or greater gain in limb fat. However, 34 percent of participants had no significant gain in limb fat by the end of the study period.

There was no significant difference in the amount of fat gained by participants in the Truvada group versus the Epzicom group.

The results also showed that greater gains in limb fat were associated with more severe limb fat loss prior to starting the study. In addition, participants with the greatest increases in limb fat were more likely to be taking zidovudine, stavudine, or didanosine treatment regimens immediately before starting the study. They also had higher fasting blood glucose levels and higher levels of interleukin 6, an inflammatory protein associated with diabetes and other metabolic diseases, prior to the change in treatment.

For more information, please see the study in PLoS One.

AIDS.gov Opens “Facing AIDS 2011” Campaign For World AIDS Day – To commemorate World AIDS Day on December 1, AIDS.gov is raising awareness through its “Facing AIDS 2011” campaign. Interested individuals are encouraged to download a “Facing AIDS” flier from the website and share why they are facing AIDS. Participants can take photos of themselves with their flier and then upload their images to the Facing AIDS website. All participants are encouraged to share their photos online with family and friends. Instructions on how to plan community events for the campaign are also available. For more information on how to participate, please see the AIDS.gov website.

Gilead Sciences Signs Agreement To Develop New Type Of Antiretroviral Drugs – Gilead Sciences has signed a licensing agreement with pharmaceutical company Boehringer Ingelheim to develop and market a new type of antiretroviral drug, initially pioneered by Boehringer Ingelheim. The new drugs are integrase inhibitors but work differently than Isentress (raltegravir) or the investigational drug elvitegravir. As a result, they are expected to be effective against HIV that is resistant to current integrase inhibitors. The agreement includes the investigational drug BI 224436, which has been tested in a Phase 1 clinical trial. For more information, please see the Gilead Sciences press release.

Theratechnologies Begins Development On New Lipodystrophy Drug – Theratechnologies announced last week that it has discovered a new potential drug in the same class as Egrifta (tesamorelin) and will begin pre-clinical testing of the new compound for treatment of lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Theratechnologies stated that the new drug candidate appears to be as effective as Egrifta but may not need to be injected, as Egrifta is. Egrifta, which was approved in the U.S. in November of last year, was the first drug approved to treat lipodystrophy. For more information, please see the Theratechnologies press release.

In a recent review, Dr. Derek Jones from the David Geffen School of Medicine at the University of California, Los Angeles discussed the use of a variety of facial fillers to treat HIV-related facial fat loss.

According to Dr. Jones, side effects from temporary facial fillers can be less severe than those from permanent fillers such as silicone, and problems with the injection of temporary fillers (such as inappropriate placement) can be easier to correct. However, temporary fillers need to be replaced and may take several injections to achieve the desired effect. They may also not be as effective for more severe cases of facial fat loss.

Temporary Facial Fillers

Dr. Jones discussed three types of temporary facial fillers in his review: hyaluronic acid, calcium hydroxylapatite, and poly-L-lactic acid.

As a person ages, the amount of hyaluronic acid in the skin decreases, leading to wrinkles and drooping skin. The breakdown of hyaluronic acid is also accelerated with sun exposure. Injectable hyaluronic acid fillers can replace the body’s hyaluronic acid and reduce the appearance of sagging skin and wrinkles.

There are currently four hyaluronic acid fillers approved by the United States Food and Drug Administration (FDA): Juvederm Ultra and Ultra Plus, Restylane/Perlane, Prevelle Silk, and Elevess. In addition, Dr. Jones stated that the filler Belotero is expected to be approved soon, and Juvederm Voluma is currently under FDA review.

Different brands of fillers provide varying degrees of volume, durability, and other factors.

According to Dr. Jones, the fillers Restylane, Juvederm, and Belotero are effective in treating the nasolabial folds, commonly known as smile or laugh lines. Previous studies have shown that each of these fillers can correct laugh lines for up to a year or longer, especially after repeat treatments.

In addition, the hyaluronic acid filler Voluma is safe and effective in providing volume to compensate for fat loss around the cheek areas in people with HIV.

Juvederm and Restylane are available with the local anesthetic drug lidocaine to relieve pain during injection.

The most common side effects for FDA-approved hyaluronic fillers are pain at the injection site, bruising, and swelling. These usually resolve within a few days after treatment.

However, Dr. Jones noted that more serious complications can occur, such as blue tinting to the skin, damage to the nerves, or death of the skin layers when the fillers are injected improperly (such as not deeply enough within the skin or too close to facial nerves); these complications can be avoided with proper injection techniques.

If hyaluronic acid fillers are improperly placed or complications arise, the filler can be degraded using injections of hyaluronidase, which dissolves the hyaluronic acid.

Another temporary facial filler is Radiesse (calcium hydroxylapatite). Calcium hydroxylapatite is a component of human bone and teeth and has been used for dental implants and coatings for more than 20 years.

When Radiesse is injected, the gel breaks down and stimulates the growth of collagen, a protein important in maintaining youthful skin.

The gel is approved to treat moderate to severe wrinkles and folds, including nasolabial folds, and HIV-associated fat loss.

Studies have shown that Radiesse is more effective and durable than collagen injections. In a study with HIV-positive patients, 80 percent had reduced fat loss after three months of treatment, and 59 percent of patients had reduced fat loss after six months of treatment.

Major side effects of calcium hydroxylapatite include swelling, bruising, and redness of the skin. Swelling and bruising can last about one week after injections, and skin redness can last for about two to three weeks after treatment.

The gel can be mixed with lidocaine to minimize pain during injection.

The final facial filler Dr. Jones discussed in his review is Sculptra (poly-L-lactic acid), which is also FDA-approved for HIV-associated fat loss.

The filler is given as monthly injections over the course of four to six months to restore face volume. The corrections can last for about one to two years.

A previous study conducted by European researchers showed that HIV-positive patients receiving Sculptra injections every two weeks for six weeks had significantly increased skin thickness at 48 and 72 weeks. No serious side effects were observed.

However, other studies have shown that Sculptra can cause lumps and nodules under the skin; proper injection techniques and regular massage of the filler after injection can help prevent lump formation.

Dr. Jones noted that in his experience, Sculptra is not effective for more advanced cases of HIV-related facial fat loss.

For more information, please see the study in Clinics In Plastic Surgery (abstract).

A recent review of facial fillers indicates that a variety of fillers are available that are safe and effective for treating antiretroviral-related facial fat loss in people with HIV.

The author suggested that surgeons properly select facial fillers, with a focus on the look of the entire face rather than specific regions, to create and restore proportion and harmony in the face. He noted that often surgeons must use a combination of several different types of fillers to obtain the best results.

Facial fat loss (lipoatrophy) is a common side effect of antiretroviral therapy, particularly for older antiretrovirals such as stavudine (Zerit) or zidovudine (Retrovir).

Although the condition does not pose any significant health risk, facial fat loss can have serious psychological consequences, such as negative self-image and depression. In extreme cases, patients may choose to discontinue treatment.

Switching to more modern treatment regimens can help prevent the condition from worsening; however, facial fat loss is extremely slow to heal. Instead, patients may choose to use injected facial fillers to replace the lost fat.

Medicare and Medicaid cover the use of facial fillers to correct facial fat loss in people with HIV under certain circumstances (see related AIDS Beacon news), and procedures may be paid for by private insurance.

In this review, Dr. Derek Jones from the David Geffen School of Medicine at the University of California, Los Angeles discussed the uses, side effects, and effectiveness of several facial fillers for the treatment of HIV-related facial fat loss.

Facial fillers fall into two categories: permanent fillers, which do not dissolve or get reabsorbed over time, and temporary fillers, which typically last one to two years. In his review, Dr. Jones discussed several fillers of each type.

Permanent Facial Fillers

According to Dr. Jones, some physicians do not favor common permanent fillers, such as liquid silicone injections, due to potential safety issues. However, Dr. Jones noted that they can give better and more durable results than temporary fillers, particularly for more serious cases of facial fat loss.

Liquid injectable silicone is a common permanent filler that was first used in the 1950s. At the time there was no standardized Food and Drug Administration (FDA)-approved product, and in the early 1990s all forms of silicone implants were banned by the FDA due to possible toxicity.

In the late 1990s, the FDA approved two forms of highly purified silicone, Silikon-1000 and Adatosil-5000, for use as retinal implants in the eye. These are also now used for soft-tissue augmentation, particularly Silikon-1000, although they are not officially approved by the FDA for this use.

In one clinical trial, highly purified silicone was studied in 77 HIV-positive patients. Patients received Silkon-1000 at monthly intervals. The authors of the trial determined that the number of treatments, amount of silicone needed, and the time to reach optimal facial correction were directly related to the severity of facial loss in the patient.

In another recent study, 135 patients with HIV were followed for at least five years after liquid silicone treatment. Results showed that silicone is safe and effective for treatment of HIV-associated facial fat loss.

Four patients in this study experienced localized hardening of the skin after treatment, which was moderate in severity and easily treated.

The second permanent facial filler Dr. Jones discussed in his review is polymethylmethacrylate, marketed as Artefill. Artefill is a facial filler approved by the FDA in 2006 to treat nasolabial folds, also known as smile or laugh lines. Artefill is also used to correct frown lines, lip lines, and mouth corners.

Artefill injections stimulate the body to produce more collagen, a protein important in maintaining youthful skin, in the face. According to Dr. Jones, results from recent studies showed that Artefill is effective in treating facial fat loss in people with HIV, acne scars, and cheek loss.

Side effects can include lumpiness and skin inflammation; Artefill can also cause permanent changes in skin texture or color if not injected properly.

Dr. Jones noted that after injections, patients should be evaluated four to six weeks later to determine if additional treatment is needed. Optimal correction usually requires two to three treatments.

For more information, please see the study in Clinics In Plastic Surgery (abstract).

The researchers noted that the drop in lipodystrophy rates is likely due to lower smoking rates and the use of newer antiretrovirals that have less effect on patients’ metabolism.

The results were presented last week at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2011).

Lipodystrophy is a common side effect associated with HIV treatments. It causes changes in fat distribution that can lead to alterations in body shape, increased levels of cholesterol and triglycerides in the blood, and a greater risk of heart problems.

Symptoms of lipodystrophy include loss of fat in the legs, face, arms, and buttocks; and an increase of fat in the stomach, upper back or neck, and breasts.

In this study, researchers from Alfred Hospital in Melbourne, Australia investigated how common lipodystrophy was in 1998 and today, when more modern antiretrovirals are available that have fewer side effects. They also examined risk factors for lipodystrophy.

The study, conducted in 2010, included 100 HIV-positive men on antiretroviral therapy who had no history of heart disease. The researchers also included data from a 1998 study at the same hospital on 144 HIV-positive men with no history of heart disease.

Results showed that the rate of lipodystrophy is still high but has fallen since 1998: 58 percent of participants in the 2010 study had lipodystrophy, compared to 69 percent of participants in the 1998 study.

This was in spite of the fact that 2010 study participants were an average of 10 years older and had taken antiretrovirals a median of nearly eight years longer, both of which increase the risk for lipodystrophy.

Results also showed, however, that 2010 study participants were more likely to report themselves as having lipodystrophy: 35 percent of participants in 2010 reported having lipodystrophy compared to 21 percent of participants in 1998.

Study participants from 2010 were less likely to be taking protease inhibitors or older drugs such as stavudine (Zerit) and zidovudine (Retrovir), which are associated with lipodystrophy. They were more likely to take non-nucleoside reverse transcriptase inhibitors, and almost 20 percent were taking entry inhibitors and/or integrase inhibitors, which are newer classes of antiretrovirals that were not available in 1998.

Participants in 2010 weighed an average of 7.7 lb (3.5 kg) more than participants in 1998 but had lower average cholesterol and triglyceride levels. They were also less likely to smoke (36 percent of participants in 2010 versus 51 percent of participants in 1998).

Risk factors for lipodystrophy in the 2010 study group included high “bad” cholesterol levels. Taking Viread (tenofovir) or Ziagen (abacavir) was associated with a lower risk of lipodystrophy.

Results also showed that participants in the 2010 study had better control over their HIV than participants in the 1998 study. Median CD4 (white blood cell) counts were 265 cells per microliter higher in the 2010 study group than in the 1998 group, and 90 percent of 2010 participants had undetectable viral loads (amount of HIV in the blood), compared to 57 percent of participants in the 1998 study.

For more information, please see the study abstract or presentation (pdf) at the IAS 2011 conference website.

Based on their results, the authors of the study suggested that genetic factors that may contribute to abnormal body fat redistribution and high cholesterol levels could eventually be used to guide HIV treatment decisions.

Drug-associated side effects are one of the major concerns associated with the use of antiretroviral therapy. Common long-term side effects of treatment include lipodystrophy, characterized by abnormal body fat redistribution, and metabolic syndrome, which includes insulin resistance, high cholesterol levels, high blood pressure, obesity, and type 2 diabetes.

According to the authors, studies of HIV-positive patients treated with antiretrovirals have shown that lipodystrophy can result in serious psychological problems and stigma, eventually leading to treatment non-adherence. Metabolic syndrome increases the risk of heart disease.

In this study, researchers from Italy examined the link between various genetic variations and the risk of lipodystrophy and high cholesterol in HIV-positive people starting antiretroviral therapy.

The study included 174 Caucasians who had started antiretroviral therapy. The majority (68 percent) of participants were male, and the median age was 38 years at treatment initiation.

Researchers analyzed participants’ DNA for seven possible genetic variations that they suspected, based on previous research, could be linked to a higher risk of lipodystrophy or metabolic syndrome. They also collected information on participants’ age, gender, weight, antiretroviral regimen, and viral load (amount of HIV in the blood).

Most of the participants (83 percent) received a protease inhibitor-based regimen as their initial regimen; the remainder were treated with a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen.

During a median follow-up period of about four years, more than half of the participants developed some form of lipodystrophy. Almost 30 percent developed abdominal fat accumulation, and 36 percent developed lipoatrophy, which involves abnormal fat wasting on the face, limbs, and buttocks.

In addition, 29 percent of participants developed high overall levels of cholesterol. About 36 percent developed high “bad” cholesterol levels over the course of the study, and 19 percent of participants developed high levels of triglycerides. Two-thirds (66 percent) developed low levels of “good” cholesterol; low “good” cholesterol levels are linked to a higher risk of heart attack.

The researchers found that participants with a particular genetic variant, called MDR-1 3435 TT, were less likely to develop abdominal fat accumulation, with a risk one fifth of that of other participants. They also found a second variant, TNF 308 GG, that doubled the risk of abdominal fat accumulation. These variants were present in 26 percent and 78 percent of participants, respectively.

The researchers hypothesized that these variants could have effects on the way the body metabolizes antiretrovirals – reducing the amount of lipodystrophy-causing drugs in the blood, for example – or on the way it regulates fat accumulation and breakdown.

In addition, the researchers found several variants that affected cholesterol and triglyceride levels. The genetic variant TNF 238 GG was associated with a six-fold higher risk of low “good” cholesterol levels, while a second variant, LPL S477X, decreased the risk of high “bad” cholesterol levels by a little less than two thirds. These variants were present in 85 percent and 26 percent of participants, respectively.

For high triglyceride levels, the variant APOEe 3/3 decreased the risk by about three fourths, while the APM1 276 GT variant increased the risk by about three-fold. The variants were present in 65 percent and 34 percent of participants, respectively.

Aside from genetic variants, the researchers found that women were 2.5 times more likely to develop trunk fat accumulation but were less likely to have low “good” cholesterol levels compared to men. Use of an NNRTI rather than a protease inhibitor as a third drug in the initial antiretroviral regimen was also linked to a decreased risk of lower “good” cholesterol levels after starting treatment.

Higher viral loads were associated with about double the risk of developing low “good” cholesterol levels after starting antiretroviral therapy. Co-infection with hepatitis C virus and older age were associated with a higher risk of increased “bad” cholesterol levels.

The researchers stated that further studies that include different populations, such as non-Caucasians, and exposure to varying antiretroviral agents are necessary to confirm their results. They also suggested additional research into the actual mechanisms linking genetic variations with higher or lower risk of lipodystrophy and cholesterol levels.

For more information, please see the study in AIDS Research and Human Retroviruses.

Dr. Rebecca Scherzer from the University of California at San Francisco presented the results at the 18th Conference on Retroviruses and Opportunistic Infections (CROI).

“Clinicians should consider measuring waist circumference and mid-arm muscle circumference in their HIV-infected patients, and [clinicians] should be aware that patients with excess central fat may not necessarily have a low enough body mass index (BMI) to alert them to [the patient’s] true level of risk,” said Dr. Scherzer.

Dr. Scherzer also noted that studies in HIV-negative patients suggest that “muscle strength is just as important, or more important, than muscle mass.” She suggested that patients with HIV work to improve muscle strength via exercise and a healthy diet.

Previous studies have shown that weight loss and loss of muscle mass lead to increased mortality in the general population, particularly as people age.

People with HIV are also prone to wasting and muscle loss, particularly at later stages of the disease if HIV goes untreated. In addition, while antiretroviral therapy has helped prevent HIV-related deaths and slowed the progression of HIV, use of antiretrovirals can lead to side effects such as lipodystrophy. Lipodystrophy is a disorder that causes a redistribution of fat in the body.

There are two types of lipodystrophy. Lipoatrophy is the loss of fat in areas such as the arms, legs, and face. Lipohypertrophy is the buildup of fat in areas such as the stomach, shoulders, back of the neck, and breasts (see related AIDS Beacon news).

In this study, the researchers wanted to determine if muscle loss, loss of fat in the limbs, or gain of abdominal fat could predict risk of death in people with HIV. The study included 1,183 HIV-positive patients from the Fat Redistribution and Metabolic Change in HIV Infection study (FRAM).

Researchers used whole-body magnetic resonance imaging (MRI) to measure each participant’s muscle and fat tissue. MRI is an imaging technique used in medicine to examine and measure internal organs and structures.

Based on the results, the researchers divided the FRAM patients into three groups of lowest, intermediate, and highest arm muscle mass, leg muscle mass, and abdominal fat.

Study participants were then monitored over time. After five years, 11 percent of study participants had died, 67 percent were alive, and the statuses of the rest were unknown.

Results showed that low arm and leg muscle mass and increased abdominal fat were each associated with a higher risk of death over the five-year period.

This was the case even after the researchers took into account other risk factors known to increase risk of death, such as kidney disease and heart disease.

HIV patients with the lowest arm muscle mass had a mortality rate of 23 percent, compared to an 11 percent mortality rate for patients in the mid-range and 8 percent in the highest arm muscle mass groups.

The researchers calculated that decreased arm muscle mass caused a 15 percent increased risk of mortality in people with HIV over a five-year period, or two additional deaths per 100 HIV-positive persons.

Decreased leg muscle mass caused a 7 percent higher risk of death, or about one additional death per 100 HIV-positive persons, and increased abdominal fat caused a 6.5 percent increased risk of death in people with HIV over a five-year period.

Loss of fat, rather than muscle, in the arms and legs was not associated with higher mortality in people with HIV.

The causes of death in the study were not known due to patient confidentiality concerns. However, Dr. Scherzer said patients with decreased arm muscle mass and higher abdominal fat were less physically active, older, and more likely to have high blood pressure and decreased kidney function. As a result, she suggested that the causes of death in this group may have been non-HIV related.

For more information, please see the abstract or the webcast on the CROI 2011 website.

However, the study authors noted that their study was small and that participants were allowed to choose whether to switch treatment or not, so the study was not randomized. Nevertheless, they concluded that switching to Reyataz (atazanavir) may have harmful effects on patients’ body fat distribution and that observed changes in deep belly fat, in particular, should be further investigated.

Kaletra (lopinavir/ritonavir) and Reyataz boosted with Norvir (ritonavir) are both antiretroviral drugs in the protease inhibitor class. Prior studies have suggested that protease inhibitors are associated with the development of lipodystrophy, a condition in which there is an abnormal redistribution of body fat.

Several studies have shown that Norvir-boosted Reyataz is less likely to cause certain metabolic problems, such as high cholesterol and triglyceride levels, than Kaletra. However, there is currently little data available on changes in body fat due to switching to Norvir-boosted Reyataz.

In this study, researchers set out to determine whether switching to Reyataz would affect body fat distribution in addition to its effects on metabolism.

The study included 83 Spanish HIV-infected patients, all of whom were taking Kaletra and had successfully achieved viral suppression (undetectable amount of HIV in the blood).

At the start of the study, 37 study participants chose to switch from Kaletra to Norvir-boosted Reyataz. The remaining 46 participants remained on Kaletra for comparison.

Both groups underwent a full body scan at the beginning of the study and at 12 months in order to evaluate body fat distribution. The researchers measured abdominal fat and the fat mass ratio (ratio of total abdominal fat to total arm and leg fat). They also calculated the proportion of study participants who had a greater than 20 percent total fat change.

After the 12 month period, researchers found an increase in abdominal fat and a higher fat mass ratio in the Norvir-boosted Reyataz group. Additionally, 38 percent of the Norvir-boosted Reyataz group had an increase of greater than 20 percent in total fat, compared to 15 percent of the Kaletra group.

Further investigation revealed that participants who gained abdominal fat after switching to Reyataz experienced both an increase in subcutaneous fat (fat under the skin) and visceral fat (deep belly fat surrounding the internal organs). Visceral fat in particular is considered to be a risk factor for heart disease and diabetes.

Consistent with previous studies, however, results also showed that participants who switched to Reyataz had significant decreases in triglyceride and “bad” cholesterol levels relative to participants who stayed on Kaletra.

The researchers found no link between the fat increases and metabolic changes such as high blood glucose levels, which are an indicator of pre-diabetes.

For more information, please see the study in AIDS Research and Human Retroviruses (pdf).

Researchers Report Promising Phase 1/2 Results For New HIV Drug VIR-576 – Results of a small Phase 1/2 clinical trial for VIR-576, a new type of antiretroviral drug under development by the small German company VIRO Pharmaceuticals, showed that it successfully reduced viral loads (amount of HIV in the blood) in treatment-naïve patients. No serious side effects were reported. VIR-576 is a new entry inhibitor, a relatively new class of antiretrovirals that includes Selzentry (maraviroc) and Fuzeon (enfuvirtide). VIR-576 works by binding to a protein on the surface of HIV, preventing it from attaching to and infecting cells. It works somewhat differently than either Selzentry or Fuzeon, and its developers hope that HIV will be less able to form drug resistance to VIR-576 than to most other antiretrovirals. While VIR-576 itself has some drawbacks – large doses are necessary and they must be administered intravenously – the researchers concluded that drugs of this type are promising and should be developed further. For more information, please see the article in Science Translational Medicine (abstract).

AIDS Healthcare Foundation Sues Tibotec Therapeutics For Overcharging – The AIDS Healthcare Foundation (AHF), a California-based HIV/AIDS treatment and advocacy group, has filed a lawsuit against Tibotec Therapeutics for overcharging for antiretroviral drugs purchased under a government pricing program. The program requires drug manufacturers to provide drugs to specific groups at reduced costs. Groups eligible for reduced prices are largely nonprofit and governmental medical providers, including AHF. AHF claims that pharmaceutical companies in the pricing program were required to lower prices beginning January 2010, but that Tibotec only implemented the changes in July 2010. AHF has also filed suit against Bristol-Myers Squibb on a similar basis. For more information, please see the AHF press release.

Clinical Trial To Investigate The Effects Of Egrifta On HIV-Associated Fat Accumulation Is Currently Recruiting Participants – A Massachusetts study is investigating the effects of Egrifta (tesamorelin) on lipodystrophy (abnormal fat accumulation) in the muscle and liver, insulin sensitivity, sugar metabolism, cardiovascular health, and inflammation in people with HIV. These conditions are often associated with HIV and HIV treatment. The researchers believe Egrifta will reduce fat accumulation in the liver and muscle, decrease inflammation and possibly improve sugar metabolism. The study is currently recruiting participants in the Boston area who are aged 18 to 60 years and have lipodystrophy. For more information, please see the United States Clinical Trials Registry.