Based on their results, the researchers concluded that the gel is a promising treatment for HIV-related facial fat loss and suggested that clinical trials should be conducted to compare the safety and efficacy of the gel to the current standard treatment, polylactic acid implants (Sculptra).

Facial fat loss (lipoatrophy) that results in hollowed cheeks 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, according to the study authors, facial fat loss is extremely slow to heal. Instead, patients may choose to use injected facial fillers to replace the lost fat. The current approved treatment for facial fat loss is polylactic acid implants, which are effective but typically need to be replenished within about two years. In addition, the implants have been associated with lumps and nodules under the skin.

Polyacrylamide hydrogel is a facial filler that is being studied as a treatment for HIV-associated facial fat loss.  It is approved and marketed in Europe under the names Eutrophill and Aquamid, but it is not yet approved for use in the United States.

Previous studies have suggested that the gel is safe and effective in people with HIV. In this study, researchers sought to verify these findings and determine whether the gel affected patient quality of life.

The study included 111 patients treated at two French clinics between 2005 and 2007. Most participants (89 percent) were male and had taken antiretrovirals for a median of nine years. All participants had severe antiretroviral-related facial fat loss, as assessed by the researchers.

Participants received between two and six injections of Eutrophill gel every two to four weeks for six months. Researchers evaluated the thickness of participants’ cheeks and other facial regions before and after treatment. They also assessed patients’ satisfaction with the treatment, changes in participants’ quality of life, and effects on their feelings of anxiety or depression. The study authors also monitored for any treatment side effects.

Participants were evaluated at the start of the study and 6, 12, and 24 months after treatment initiation. Twenty-six percent of patients received at least one additional injection between months 6 and 12 of the study, and 35 percent of patients received at least one additional injection between months 12 and 24.

Results showed that participants’ average cheek thickness increased by 4.4 mm 12 months after treatment, with an additional average increase of 0.9 mm 24 months after treatment.

In addition, external reviewers who examined photographs of patients at 6 months, 12 months, and 24 months after treatment initiation noted an improved appearance in 88 percent of study participants at all time points.

Study participants also reported a significant increase in overall life satisfaction after 6, 12, and 24 months. However, the proportion of participants reporting high anxiety (48 percent) or depression (25 percent) did not change over the course of the study.

The researchers found no serious side effects related to the treatment. Three patients developed nodules under the skin due to the injections and three patients experienced temporary local inflammation. None of the participants interrupted treatment due to side effects.

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

Based on their results, the review authors recommended that people with HIV receive routine screening for diabetes before starting antiretroviral therapy, three to six months after starting therapy, and once a year thereafter.

Diabetes is a chronic disease marked by high levels of sugar (glucose) in the blood that results from the body’s inability to effectively use or produce insulin, a hormone that controls blood sugar levels.

Diabetes is a large and growing problem in the United States, with around 8 percent to 12 percent of the population estimated to have the disease, primarily older adults. Traditional risk factors for diabetes include family history, smoking, ethnicity, increased body weight, and older age.

In their review, the authors examined the evidence for increased risk of diabetes in people with HIV, particularly related to the use of antiretrovirals. They also discussed the diagnosis and management of diabetes in HIV-positive patients.

Diabetes In People With HIV: Risk Factors And Antiretroviral Use

In addition to traditional risk factors, which affect a disproportionate number of people with HIV, antiretroviral therapy may also increase the risk for diabetes.

According to the review authors, results from previous research indicate that HIV-positive individuals on antiretroviral therapy are almost three times more likely to develop diabetes than people with HIV who are not taking antiretrovirals.

The risk of acquiring diabetes varies depending on the type of antiretrovirals used, although results are somewhat conflicting.

Results from several studies have implicated protease inhibitors as a risk factor for diabetes. The rate of diabetes in people with HIV taking protease inhibitors is around 7 percent to 13 percent, compared to around 3 percent for previously untreated people with HIV. Researchers have also shown that protease inhibitor use can lead to insulin resistance and high levels of sugar in the blood.

Crixivan (indinavir), in particular, is linked to a higher risk of diabetes. Results are conflicting for Kaletra (lopinavir/ritonavir), with some studies showing higher risk of insulin resistance and others finding no effect. Other protease inhibitors, such as Reyataz (atazanavir), may not be linked to a higher diabetes risk.

Researchers have also found that the use of certain nucleoside reverse transcriptase inhibitors (NRTIs) may increase the risk for diabetes, with an 8 percent increased risk of high insulin levels for each year of NRTI exposure.

This is particularly the case for older NRTIs such as stavudine (Zerit), zidovudine (Retrovir), and didanosine (Videx); the newer NRTI Viread (tenofovir), which is also a component of Truvada (emtricitabine/tenofovir) and Atripla (efavirenz/emtricitabine/tenofovir), has not been linked to increased risk of diabetes.

Currently, there is no evidence that non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, and CCR5 antagonists increase the risk for diabetes in people with HIV.

Diagnosis And Treatment Of Diabetes In HIV-Positive Individuals

The International AIDS Society has set up guidelines for the diagnosis and treatment of diabetes in people with HIV, which, according to the review authors, are similar to those established by the American Diabetes Association:

• Glucose and lipid levels (such as cholesterol and triglycerides) should be measured in HIV-positive patients before beginning antiretroviral therapy, three to six months after initiating therapy, and then annually afterwards
• Individuals with a family history of diabetes and/or obesity should consider taking a standard oral glucose tolerance test, which measures the body’s ability to use glucose and is used to diagnose diabetes
• Unlike for HIV-negative individuals, HbA1c levels, which are usually used as a measure of blood glucose levels over a two to three month period, are not recommended for use as a diagnostic tool in HIV-positive patients
• For individuals diagnosed with diabetes, regular exercise, a healthier diet, and self-monitoring of blood sugar are suggested for both HIV-negative and -positive patients
• If exercise and diet alone are not keeping patients’ diabetes in control, drug therapies should be used. As in HIV-negative individuals with diabetes, drugs including thiazolidinediones (such as Actos (pioglitazone)) and metformin (Glucophage) can be used. These drugs help the body respond to insulin and control blood sugar levels.

In addition, the review authors suggested that patients discuss the potential of developing diabetes with their doctors when choosing an antiretroviral therapy regimen, since avoiding certain antiretrovirals may decrease the risk for diabetes.

The review authors noted that more research is needed on best treatment of diabetes in people with HIV, as many anti-diabetes drugs have not been investigated in HIV-positive patients. They also noted that thiazolidinediones and metformin have not been shown to decrease the risk of heart disease, a common complication of diabetes, and should therefore be used only to lower blood glucose levels. There is no evidence that they are effective for treating pre-diabetes (insulin resistance or glucose intolerance).

For more information, please see the study in Best Practice & Research Clinical Endocrinology & Metabolism (abstract).

While the majority of infants treated with Kaletra had no symptoms, three premature infants treated with Kaletra experienced life-threatening problems, including extensive heart damage, low levels of sodium in the blood, and high levels of potassium in the blood.

“The association between [Kaletra] and transient adrenal dysfunction in HIV-uninfected newborns suggests that [Kaletra] and more generally ritonavir boosting should be used with caution, if at all, in premature infants, and if this drug regimen is administered to full-term infants, it should be used under electrolyte monitoring,” wrote the authors of the study.

The authors also suggested additional studies to determine the fundamental cause of Kaletra toxicity in newborns, particularly premature infants.

To decrease the risk of transmission of HIV from HIV-positive mothers to their infants, United States Department of Health and Human Services guidelines recommend treating newborns with a six-week course of antiretrovirals immediately after birth. This practice, combined with treatment of HIV-positive women with antiretrovirals during pregnancy and labor, has reduced the mother-to-child HIV transmission rate to around 1 percent.

In the U.S., zidovudine (Retrovir) is the preferred treatment for newborns and premature infants. However, in some cases, such as when the mother is diagnosed with HIV late in pregnancy or has persistent viral replication at delivery, physicians may feel that use of other or additional antiretrovirals, such as Kaletra (lopinavir/ritonavir), is warranted.

Kaletra is available as an oral solution and is considered a preferred treatment option for babies and children. It is approved in the U.S. for HIV-infected newborns older than 14 days and in Europe for children older than two years.

However, the U.S. Food and Drug Administration warned recently that Kaletra may be toxic when given to premature newborns (see related AIDS Beacon news), possibly due to problems with metabolizing one of the ingredients.

In addition, through a screening program for inherited disorders of the adrenal glands, French researchers recently found that children treated with Kaletra at birth had a temporary increase in 17-hydroxyprogesterone (17OHP), a hormone produced mainly by the adrenal glands.

According to the study authors, this finding suggests that the use of Kaletra leads to adrenal dysfunction in children. The adrenal glands are located right above each kidney and produce a range of hormones that are released into the blood. Some of these hormones are needed to maintain the balance of sodium and potassium levels in the body, react to stress, and regulate blood pressure.

Symptoms of adrenal dysfunction include abnormal levels of electrolytes, such as sodium and potassium, and cardiogenic shock, a state in which the heart has been damaged so much that it is unable to supply enough blood to the organs of the body.

In this study, researchers investigated the risk of adrenal gland problems in newborns treated after birth with Kaletra.

In their study, the researchers included 50 newborns treated with Kaletra and 108 newborns treated with zidovudine who were part of the French screening program for inherited disorders of the adrenal glands.

The researchers measured the levels of two adrenal hormones, 17OHP and dehydroepiandrosterone-sulfate (DHEA-S), from blood samples taken two to five days after birth and evaluated the infants’ medical records for symptoms of adrenal dysfunction.

Results showed that 14 percent of babies treated with Kaletra had abnormally high levels of 17OHP, compared to none of the infants treated with zidovudine. In addition, the average 17OHP levels for 42 full-term infants treated with Kaletra were three times higher than the average 17OHP levels for 93 full-term infants on zidovudine.

The average DHEA-S levels were nearly 20 times higher among 18 newborns treated with Kaletra compared to 17 zidovudine-treated infants.

The researchers found the highest levels of 17OHP and DHEA-S in infants who were also exposed to Kaletra before birth, as part of their mothers’ antiretroviral regimens.

Despite the high hormone levels, none of the full-term infants treated with Kaletra had symptoms of adrenal dysfunction. However, three premature babies taking Kaletra who also had been exposed to Kaletra before birth experienced potentially life-threatening symptoms of adrenal gland problems: high levels of potassium and low levels of sodium in the blood and one case of cardiogenic shock.

The researchers noted that these symptoms diminished once treatment with Kaletra was completed.

For more information, please see the study in the Journal of the American Medical Association (abstract).

“What is surprising…is that patients who came off the medication many years ago may still be vulnerable to these changes,” said Professor Patrick Chinnery, lead author of the study, in a press release.

The aging appears to be caused by damage to cells’ energy production units, called mitochondria.

“HIV clinics were seeing patients who had otherwise been successfully treated but who showed signs of being much older than their years. This was a real mystery. But colleagues recognized many similarities with patients affected by mitochondrial diseases – conditions that affect energy production in our cells – and referred them to our clinic,” said Prof. Chinnery.

The authors of the study are currently investigating how to repair or prevent the damage caused by the antiretrovirals. Prof. Chinnery noted that exercise has been beneficial to HIV-negative people with these mitochondrial diseases and may help people who have taken nucleoside reverse transcriptase inhibitors (NRTIs) as well.

NRTIs were the first class of drug developed to treat HIV. Today they still provide the backbone for many treatment regimens, with current U.S. guidelines recommending two NRTIs plus a third antiretroviral from a different class as the optimal treatment for HIV.

However, previous studies have shown that NRTIs, particularly older NRTIs, may cause damage to mitochondria, which are small structures within cells that supply cellular energy. According to the study authors, damage to mitochondria has been linked to premature aging.

Mitochondria damage has also been linked to heart disease, dementia, and problems such as neuropathy, a nerve condition that causes pain, numbness, or tingling in the extremities. This could be why some HIV-positive individuals taking antiretrovirals have symptoms of these diseases at an early age.

In this study, researchers investigated the effect of NRTIs on the mitochondria of HIV-positive individuals. In particular, they compared mitochondrial damage in HIV-positive people who had previously taken NRTIs to levels of damage in two groups: HIV-positive people who had not been treated and therefore were not exposed to NRTIs, and HIV-negative people.

The study included 33 HIV-positive adults 50 years of age or under and 10 HIV-negative adults who were similar in age. The researchers collected information on HIV-positive participants’ current and past antiretroviral regimens, including length of NRTI exposure. All participants with NRTI exposure had taken at least one of the following: zidovudine (Retrovir), stavudine (Zerit), didanosine (Videx), or zalcitabine (Hivid).

The researchers also collected small tissue samples from participants’ muscles to examine their mitochondria and the DNA inside the mitochondria. Mitochondria have their own DNA, which is separate from the cell’s normal DNA.

Results showed that participants who had been treated with NRTIs showed more signs of damaged mitochondria than participants who had not been exposed to NRTIs or who were HIV negative. In particular, participants who had been treated with NRTIs had levels of a mitochondrial DNA mutation tied to aging that were similar to those in very elderly healthy adults.

The mutation, called the ‘common deletion,’ occurs spontaneously in adults as they get older and builds up over time. The mutation is irreversible and is thought to lead to many of the symptoms of aging.

Further analysis showed that NRTI exposure did not appear to cause the mitochondrial DNA to mutate faster or more often. Instead, the researchers hypothesized that the drugs caused DNA that had already mutated naturally to copy itself more often, resulting in a greater overall amount of mutated DNA.

The researchers noted that this may be why complications of NRTI treatment that are related to the mitochondria, such as neuropathy, are more common in older HIV-positive adults, who already have a larger number of these mutations.

For more information, please see the study in Nature Genetics (abstract).

Based on their results, the study authors recommended that people with HIV be monitored for vitamin D deficiencies and given supplements or alternate antiretroviral regimens if severe deficiencies develop.

People living with HIV often have lower levels of vitamin D, which is an important vitamin obtained from sunlight, diet, and vitamin supplements.

Vitamin D is important for the absorption of calcium, bone formation, muscle strength, reduction of inflammation, and for a healthy immune system.

Studies have shown that very low vitamin D levels are associated with a greater risk of osteoporosis, muscle weakness, and certain types of cancers. Studies have also shown that people with HIV who are taking antiretrovirals are more prone to vitamin D deficiencies (see related AIDS Beacon news).

In this study, researchers aimed to determine whether vitamin D deficiencies are associated with particular antiretrovirals and if switching treatments could help alleviate the deficiencies.

At the beginning of the study, participants’ vitamin D levels were measured by blood tests. All 219 study participants were taking antiretroviral drugs at the time. All regimens included at least two nucleoside reverse transcriptase inhibitors (NRTIs).

Participants then switched to treatment with Prezista (darunavir) boosted with Norvir (ritonavir). Participants either took Prezista plus Norvir alone or in combination with two NRTIs.

After two years, the participants’ vitamin D levels were measured again and compared to levels from the beginning of the trial.

Results showed that at the beginning of the study, low vitamin D levels were associated with winter months, being black, and taking Sustiva (efavirenz) or zidovudine (Retrovir).

By the end of the trial, there were fewer study participants with severe vitamin D deficiency than there were at the start of the study. This was true regardless of participants’ initial antiretroviral regimen; however, the increases were greatest for those who had switched from Sustiva or zidovudine.

Participants switching from Sustiva or zidovudine had average blood vitamin D levels increase around 40 percent over the two year period, compared to an average increase of less than 30 percent for other antiretrovirals.

The researchers noted that due to the long period of time between blood samples, it was not possible to evaluate how quickly vitamin D levels increased after switching treatment.

There were no differences in vitamin D levels between participants who took Prezista alone versus in combination with NRTIs.

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

The guidelines contain updated recommendations in several areas, including diagnosis of HIV in infants, start of antiretroviral therapy, selection of antiretrovirals, and adherence to antiretroviral therapy in children and teenagers.

The guidelines now also include a rating system to indicate the strength of each recommendation, and formatting changes have been implemented to improve readability. For example, a section on drug side effects in children that includes information on risk factors, symptoms, preventative measures, and treatment options is now presented in a table format for ease of use.

The guidelines are intended for use by doctors and other health care professionals when treating HIV-positive children and teens.

Key updates to various sections of the guidelines are summarized below.

Diagnosis Of HIV In Infants

The guidelines now recommend HIV testing at birth for infants who are at high risk for contracting the virus. This includes babies born to HIV-positive mothers who did not receive prenatal care or prenatal antiretroviral therapy, or who had HIV viral loads (amount of virus in the blood) greater than 1,000 copies per milliliter near the time of delivery.

HIV infection in adults is usually diagnosed by looking for antibodies – proteins made by the immune system to help identify and fight bacteria and viruses. In infants, however, tests for HIV antibodies may lead to false-positive results, as children of this age group often still carry their mothers’ HIV antibodies.

To avoid a false diagnosis, the guidelines continue to recommend tests that detect the virus itself to determine HIV status in infants younger than 18 months. This includes HIV DNA PCR assays and HIV RNA tests, both of which can detect the HIV virus directly.

The guide also continues to recommend that babies be tested for HIV at 14 to 21 days after birth, age 1 to 2 months, and 4 to 6 months of age.

Start Of Antiretroviral Therapy

Suggestions for when to initiate antiretroviral therapy vary according to age group.

Antiretroviral therapy is now recommended for children older than 12 months who have normal CD4 (white blood cell) counts but HIV viral loads of 100,000 copies per milliliter of blood or higher, even if their symptoms are mild or nonexistent.

For children under the age of 12 months, the guidelines continue to recommend starting antiretroviral therapy regardless of CD4 count, viral load, or the presence or absence of symptoms. Several studies have shown that starting therapy early in children of this age significantly reduces the chances a child will progress to AIDS or die.

In children with normal CD4 counts whose HIV viral loads are less than 100,000 copies per milliliter, and who have mild or no symptoms, initiation of treatment can be either considered or deferred.

Selection Of Antiretroviral Drugs For Treatment Naïve Patients

As with adults, all HIV-positive children should be treated using combination therapy that includes at least three different antiretroviral drugs from two different classes.

However, the updated guidelines now indicate that non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapy is not recommended for children younger than 3 years of age who have been exposed to single dose Viramune (nevirapine).

Viramune is often used to prevent mother-to-child transmission. Babies who have been exposed to Viramune before birth have a higher risk of drug resistance to Viramune after birth. They may also have a higher chance of treatment failure with NNRTI-based antiretroviral therapy.

For children under 3 years of age who have been exposed to Viramune, the preferred treatment is a Kaletra (lopinavir/ritonavir)-based regimen.

In addition, Viramune is not recommended in girls after puberty who have CD4 counts of 250 cells per microliter or higher, and Sustiva (efavirenz) is not recommended in sexually active teenage girls unless contraception can be reliably guaranteed.

Other antiretrovirals that are not recommended are Viracept (nelfinavir) for children under 2 years of age, Sustiva in children under 3 years of age, and unboosted Prezista (darunavir), Invirase (saquinavir mesylate), or Aptivus (tipranavir).

Drugs that should not be combined in children include Epivir (lamivudine) plus Emtriva (emtricitabine), zidovudine (Retrovir) plus stavudine (Zerit), or dual NNRTI regimens.

The guidelines also recommend against once daily (rather than twice daily) dosing of Kaletra, boosted Prezista, and boosted or unboosted Lexiva (fosamprenavir) in children. Although once-daily doses of these antiretrovirals have been approved in adults, the effectiveness of once-daily dosing versus twice-daily dosing has not been shown in children.

The guide continues to recommend that treatment naïve patients (patients who have never received antiretroviral therapy) complete antiretroviral drug resistance testing before choosing which drugs to use for treatment.

Adherence To Antiretroviral Therapy

Adherence to therapy can often be difficult for children and teenagers. Ensuring that patients follow their treatment regimens is important because missing doses can cause HIV to develop resistance to treatment, leading to treatment failure.

The guidelines now recommend that at least one method to monitor adherence, such as self-reporting of missed doses or pharmacy refill checks, be used in addition to viral load tests.

The updated guidelines also suggest prescribing once-daily antiretroviral therapy when possible rather than twice-daily dosing, since studies in adults have shown once-daily dosages promote better adherence.

For more information, please see the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection (pdf).

The guidelines include updates on preferred regimens for prevention of HIV transmission during pregnancy.

According to the report, fewer than 200 children are now born with HIV in the United States each year, as a result of efforts to limit mother-to-child transmission.

Transmission of HIV from a pregnant woman to her baby can occur during pregnancy, labor, or while breastfeeding after the baby is born. To prevent this, women are usually treated with antiretrovirals throughout the pregnancy and are told not to breastfeed their babies.

In this latest report, the NIH now recommends that pregnant women with HIV who are not already taking antiretrovirals start taking them sooner than previously suggested. The NIH suggests initiating treatment after the first trimester, and no later than 28 weeks into the pregnancy.

The guidelines also recommend pregnant women take a combination regimen consisting of at least three drugs, preferably two nucleoside reverse transcriptase inhibitors (NRTIs) and one non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor.

The recommended NRTI regimen is Combivir (zidovudine/lamivudine), based on clinical trials demonstrating its effectiveness.

The recommended NNRTI is Viramune (nevirapine), although only in women with CD4 cell counts of less than 250 cells/mm3 unless the benefits outweigh the risk of potential liver toxicity. Women already taking Viramune may continue during pregnancy.

The recommended protease inhibitor regimen is Kaletra (lopinavir/ritonavir). Alternative protease inhibitors include Norvir (ritonavir) in combination with Invirase (saquinavir), Crixivan (indinavir) or Reyataz (atazanavir).

Several treatments are not recommended for part or all of the pregnancy:

• The combination of stavudine (Zerit) and didanosine (Videx) are not recommended since they may cause serious side effects, including liver failure, in pregnant women.

• Sustiva (efavirenz) should not be taken in the first trimester of pregnancy because of possible harm to the baby. Sustiva is also an ingredient in Atripla (efavirenz/emtricitabine/tenofovir).

• Viread (tenofovir) should only be used when there is intolerance or resistance to zidovudine (Retrovir) or if the pregnant woman has hepatitis B because it may harm the baby. Viread is also an ingredient in Atripla and Truvada (emtricitabine/tenofovir).

• There is not yet enough data on Intelence (etravirine), Prezista (darunavir), Lexiva (fosamprenavir), Aptivus (tipranavir), Fuzeon (enfuvirtide), Selzentry (maraviroc), or Isentress (raltegravir) to recommend their use in pregnancy, although in some cases they may be used if other drugs are not well tolerated.

Prevention of mother-to-child transmission in HIV-positive women with hepatitis B (HBV) is also discussed. Treatment options depend on whether the mother requires anti-HIV treatment for her own health, anti-HBV treatment, or both.

The NIH also reaffirmed its recommendation that HIV-positive women should avoid breastfeeding. Although clinical trials in Africa have shown that antiretrovirals reduce the chances of transmitting HIV through breastfeeding, there is still a risk.

Since women in the U.S. have a safe, viable alternative to breastfeeding – formula feeding – the NIH strongly discourages HIV-positive women from breastfeeding.

After the baby is born, antiretroviral treatment of the infant is usually continued to ensure infection does not occur. The recommended treatment is zidovudine for six weeks after birth. In the new guidelines, the NIH warns that combining zidovudine with other treatments is not well-studied and should be done with caution.

Both Norvir and Kaletra have been associated with heart block, a problem with the heart’s electrical system, in babies, and therefore require especially close monitoring if used in infants.

Finally, food pre-chewed by HIV-positive caregivers should not be given to infants since this potentially increases the risk of HIV transmission.

The NIH welcomes feedback on the guideline revisions. Comments should be sent to ContactUs@aidsinfo.nih.gov with the subject line “Perinatal Comments” by June 7, 2010.

For more information, please see the complete guidelines at the NIH (pdf) website.

ESAs are used to treat anemia in individuals with chronic kidney failure, undergoing chemotherapy, HIV patients using zidovudine (Retrovir) and to reduce the number of blood transfusions during and after particular major surgeries. The mechanism of action of ESAs is to stimulate red blood cell production by the bone marrow.

The ESAs that are included in the REMS program are Epogen (epoetin alfa), Procrit (epoetin alfa), and Aranesp (darbepoetin alpha).

Amgen, the manufacturer of ESAs, introduced REMS because studies showed an increase risk of tumor growth and shorter survival rates in cancer patients taking ESAs. In non-cancer patients taking ESAs for other conditions, such as HIV patients taking EDAs for anemia, studies found an increase in risk of a heart attack, heart failure, stroke or blood clots.

The main requirement for REMS is that all health professionals must provide patients with a Medication Guide that outlines all the risks and benefits of ESAs.

Additionally, ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology program was developed as additional guidance for health professionals that provide treatment to cancer patients.

One main goal of REMS is to help physicians and patients in making informed decisions by providing information on the risks of ESAs. Another goal is to increase the survival rate and decrease the number of poor tumor outcomes through ESA APPRISE.

Currently, ESAs are not approved for the treatment of side effects of anemia, such as fatigue, in cancer, surgical or HIV patients taking zidovudine.

To ensure safe usage, the FDA and Amgen have changed the prescribing information for these drugs, which includes a new boxed warning, updated warning, and changes to the dosage and administration sections.

For more information, please see FDA’s press release and FDA’s transcribed podcast.

In a recent study conducted at the Washington University School of Medicine in St. Louis, researchers have found that HIV-related cognitive impairments are similar to Alzheimer’s related dementia in one aspect – the presence of low levels of the protein amyloid beta in the spinal fluid.

However, the progression towards cognitive dysfunction in HIV patients differs from that in patients with mild Alzheimer’s disease.

According to the researchers, proteins found in the fluid surrounding the brain and the spinal cord were different in the two cases. Thus, although HIV patients may exhibit the same symptoms that Alzheimer’s patients do, these HIV patients do not have Alzheimer’s.

This finding implies that treatments used to care for patients with Alzheimer’s disease may not be effective in treating HIV patients with memory problems.

In the study, researchers examined the spinal fluid of 49 HIV patients who were exhibiting cognitive impairments, in addition to 21 HIV patients with normal cognitive function, 68 patients with mild Alzheimer’s disease, and 50 healthy individuals who had no memory problems.

The participants were studied for the presence of amyloid beta protein in the spinal fluid.

Amyloid beta accumulates in the brains of patients with Alzheimer’s, which leads to lower levels of this protein in the spinal fluid.

Researchers expected to find low levels of the protein in only Alzheimer’s patients; however, HIV patients with cognitive impairments also showed low levels of amyloid beta in the spinal fluid.

On the other hand, the patients who had Alzheimer’s disease were found to have higher levels of the protein tau, which is a protein associated with tangled nerve fibers in the brain.

This difference in the levels of tau suggests that Alzheimer’s disease and HIV associated memory loss are not completely the same.

The dementia associated with HIV-positive individuals is known as the AIDS Dementia Complex (ADC). . It is believed that ADC occurs as a result of brain cells that are infected with the virus.

ADC leads to nervous system and mental symptoms, such as loss of concentration, forgetfulness, loss of memory, problems with thinking, inability to focus for long periods of time, and irritability, among others.

The most commonly used drug to treat ADC is zidovudine (Retrovir), which is used in high doses. However, other drugs that can cross the blood-brain barrier may also be in the future.

Currently, a drug by the name of nimodipine is undergoing clinical trials for usage in the treatment of ADC. Nimodipine, a calcium channel blocker, is currently used for the treatment of high blood pressure.

For more information, please see the Washington University School of Medicine Web site (press release).

The update allows for treatment to begin at four weeks of age, as long as children weigh at least 4 kilograms (8 lb 13 oz). Previously the FDA had recommended starting children on zidovudine at six weeks of age.

Zidovudine, also known as azidothymidine (AZT), was the first drug approved for use against HIV in 1987. It is used for treating both adults and children with HIV infection and to prevent HIV transmission to children born to HIV-positive mothers.

Zidovudine can be administered as a tablet or capsule or as a syrup for children too young to swallow pills.

Initially, treatment recommendations for children included three daily doses of zidovudine. The amount was calculated based on the child’s body surface area.

In September 2008, the FDA approved a more convenient dosing regimen of twice a day for children six weeks to 18 years of age. It also included a way to provide drug amounts by the child’s weight in addition to body surface area.

For more information on the revised dosages for children, please visit the FDA Web site.