News (Updated October 16, 2011)

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New HIV Treatment Guidelines Focus on Comorbid Conditions

Daniel M. Keller, PhD

October 16, 2011 ( Belgrade , Serbia ) — The latest guidelines of the European AIDS Clinical Society (EACS), released here at the society's 13th European AIDS Conference, give special emphasis to comorbid conditions that may occur in patients infected with HIV.

"The contemporary challenge in HIV medicine is no longer to suppress the virus but actually to maintain health of patients with HIV, and the major focus now and the dominating reason for why people are still getting sick, even for those who are in care, is the development of various co-morbidities," said Jens Lundgren, MD, DMSc, professor in the Department of International Health, Immunology and Microbiology at the University of Copenhagen, Denmark, director of the Copenhagen HIV Program in Denmark, and chairman of the section on comorbidities of the guidelines committee.

Fortunately, suppression of HIV has become so effective that comorbid conditions are a real concern. "HIV physicians are great in treating the virus but may not have the skill set necessarily to deal with the prevention and treatment of the co-morbidities," he noted. "We have involved experts in the fields of the organ diseases, and therefore we believe that we are providing contemporary guidance on that."

This focus on comorbid conditions constitutes a major revision to the previous set of guidelines, issued in 2009. The most recent set, version 6, is available at www.europeanaidsclinicalsociety.org in English and several other languages. Guidelines have been issued every 2 years at the biennial EACS conference.

Organization of Guidelines

The goal of the design of the guidelines was to make them easy to use in routine clinical practice yet comprehensive enough to address the patient as a whole. The guidelines are organized in 4 sections:

Assessment of HIV-infected patients at initial and subsequent visits;

Antiretroviral treatment of HIV-infected patients;

Prevention and management of noninfectious comorbid conditions with HIV; and

Clinical management and treatment of chronic hepatitis B and C co-infection in HIV-infected adults.

Dr. Lundgren advised that clinicians cannot use the same approach in treating comorbid conditions with HIV as they do in the general population since HIV affects the risk for diseases in various organs. "Equally, the medicines that you use to prevent and treat these comorbidities interact with the drugs that we are using to treat the HIV virus itself," he said at a news conference that Medscape Medical News attended. "Therefore, it's quite important that when you care for people with HIV that you have a comprehensive look at the person rather than just focusing on the virus itself."

Beginning on page 10 of the printed English version is a 6-page chart delineating a standard of care for the assessment of HIV-infected patients at initial and subsequent visits through interviews and laboratory tests. It deals with history (including medical, psychosocial, and sexual and reproductive health), HIV disease, co-infections, and noninfectious comorbid conditions.

A Web version in development (links at www.europeanaidsclinicalsociety.org) will expand on the print versions with additional information, tables, and links to resources on lifestyle interventions, antidepressant drugs, renal tests, drug dosage adjustments for renal impairment, other drugs and dosing with comorbid conditions, drug dependency and addiction, management of metabolic disorders, and activities of daily living.

Specific Features

The guidelines help clinicians assess patients' readiness to initiate treatment with antiretroviral drugs based on behaviors, cognitive problems, level of health literacy, health insurance and access to drugs, and social support and disclosure. Then they make 3 levels of recommendation for initiating therapy according to the CD4 cell count and the presence of various health conditions and comorbid conditions. The recommendations are:

R: recommended

C: consider (some level of uncertainty; more evidence from randomized trials is needed)

D: deferral of therapy

Significant attention is given to adverse effects and drug-drug interactions.

Noninfectious Comorbid Conditions in HIV

Tables or flow charts lead clinicians through cancer screening, including for hepatocellular carcinoma in the presence of cirrhosis; prevention of cardiovascular disease; hypertension diagnosis and management; and treatment of diabetes, depression, bone, and kidney disease.

Dr. Lundgren said all patients should be scored for their risk for cardiovascular disease with an HIV-specific risk equation, and one should consider modifying antiretroviral therapy if the 10-year risk for a cardiovascular event is greater than 20%.

An update from the 2009 guidelines concerns lipid-lowering therapy, which is now recommended only if the 10-year risk is greater than 20% in primary prevention.

Another modification from the 2009 version concerns blood pressure. "For people diagnosed with hypertension with an age of less than 55 [years], the recommended initial medication is an [angiotensin-converting enzyme] inhibitor whereas for people who are above 55 or black patients of any age, the recommended first choice is a calcium-channel blocker," Dr. Lundgren said. If single-agent therapy is not sufficiently effective, a diuretic may be added. "This is a fairly substantial change in recommendations for management of hypertension compared to the 2009 [guidelines], and again, this is done out of the advice of colleagues expert in the hypertension field," he said.

He noted that there has been much discussion of what is the appropriate cut-off for the diagnosis of impaired glucose tolerance, and the guidelines panel agreed on a fasting plasma glucose level of 5.7 to 6.9 mmol/L (110 to 125 mg/dL), as recommended by the World Health Organization and the International Diabetes Federation in 2005.

For first-line treatment, the panel recommends first considering use of metformin or possibly sulfonylureas, depending on specific patient characteristics. HIV-specific factors can affect glycated hemoglobin values, so plasma glucose may be a better indicator of the need for treatment. As good practice would dictate, clinicians are urged to screen their diabetic patients for nephropathy, retinopathy, and polyneuropathy.

Screening for kidney disease is an evolving area, but Dr. Lundgren advised that "it is absolutely clear now that we do need HIV clinics to start to screen the urine for protein in order for you to be able to calculate the urine protein-to-creatinine ratio because this has major impact not only on the progression of the kidney disease but also on extra-renal complications for people with impairment of renal function... so we can no longer just take blood from patients."

It is also important to determine the estimated glomerular filtration rate, and there are various standard methods. A table in the guidelines has been simplified from the previous version for managing individual patients according to estimated glomerular filtration rate and the urinary protein-to-creatinine ratio.

The antiretroviral drugs tenofovir, indinavir, and atazanavir can be nephrotoxic, and a table presents management strategies in this still-evolving area. "The question at the moment is whether there is an immediate hit from using these drugs or whether there is a gradual deterioration of renal function," Dr. Lundgren said.

A section on vaccination lists rationales, dosing, and schedules in the setting of HIV infection, as well as the use of live vs attenuated vaccines, which ones to combine or not, and assessing effectiveness using antibody titers.

Recreation and Enjoyment of Life

The guidelines help clinicians make recommendations to their patients who want to travel. A table provides general precautions, advice on antiretroviral therapy, and the need for extra awareness because of their heightened susceptibility to food and insect-borne diseases. It also refers people to www.hivtravel.org for advice on travel restrictions.

A new section gives clinicians systematic guidance on assessing and treating sexual dysfunction in people living with HIV, including taking a general sexual history, determining the nature of the complaint, identifying the cause of the problem, and making the appropriate referral.

EACS sponsored development of the guidelines and did not receive any industry support. Dr. Lundgren has disclosed no relevant financial relationships. He chaired the comorbidity section on the guidelines committee.

13th European AIDS Conference, Belgrade , Serbia . Guidelines presented at a special session. No abstract. Presented October 14, 2011.

Diagnostic imaging 'can show HIV progression'

 Future HIV treatment could be more accurate due to a new discovery which utilises MRI scans.

 Scientists at Northwestern University and North Shore University Health System used the machines to test the brain activity of a group of patients who had been infected for less than one year and compared the results to a control group of healthy people.

 Researchers found "prominent changes" of the functional connectivity in the visual networks of the HIV patients.

 Diminished cognitive functions affect around 50 per cent of sufferers and can impair a range of sensory functions such as memory, attention and verbal capabilities.

 "These findings indicate that changes in brain function are occurring very early in HIV infection and subclinical alterations in functional connectivity may reflect vulnerability to cognitive decline," said Ann Ragin, the principal investigator from Northwestern University Medical School

According to the Aids charity Avert, 86,500 people were living with the disease in the UK at the end of 2009.

 

Aurobindo uses patent pool for generic AIDS drugs

Oct 11 2011

LONDON (Reuters) - India 's Aurobindo Pharma has become the first major generic drugmaker to join a patent pool designed to make HIV/AIDS treatments more widely available to the poor, paving the way for it to sell cheap medicines in many countries.

The Medicines Patent Pool said on Tuesday the agreement would allow Aurobindo to make a range of AIDS drugs licensed to the pool by Gilead Sciences, the leading maker of HIV drugs, in July.

Aurobindo has also elected to take advantage of a key provision in the pool's licenses in order to sell one drug, tenofovir, to a wide range of countries without paying royalties. These could include several middle-income countries such as Argentina , Brazil , Chile , Colombia , Malaysia , the Philippines , Ukraine and Uruguay .

Around 33 million people worldwide have the human immunodeficiency virus (HIV) that causes AIDS. Most live in Africa and Asia , where medicines have to be very cheap to allow those who need them to be able to afford them.

The Medicines Patent Pool, launched by the UNITAID health financing system that is funded by a tax on airline tickets, aims to address the problem by creating a system for patent holders to license technology to makers of cheap generics.

(Reporting by Ben Hirschler; Editing by David Holmes)

 

UK study shows how better HIV drugs extend lives

By Kate Kelland

LONDON Oct 12 , 2011 (Reuters) - Life expectancy for people in Britain who have HIV rose by 15 years between 1996 and 2008, thanks largely earlier diagnosis and treatment with better, less toxic drugs, scientists said on Wednesday.

While life expectancy for HIV patients is still lower than in the general population, dramatic progress in reducing side effects from drugs, offering them as combination therapies and starting treatment earlier have helped turn HIV into a chronic disease with a good prognosis, the researchers said.

In a study published in the British Medical Journal, the researchers added that the average lifespan of HIV positive patients should increase further with guidelines recommending they start treatment even earlier with modern, improved drugs.

"These results are very reassuring news for current patients and will be used to counsel those recently found to be HIV-positive," said Mark Gompels of Britain 's North Bristol NHS Trust, who co-led the study.

Around 34 million people globally have the human immunodeficiency virus (HIV) that causes AIDS, and the vast majority of them live in sub-Saharan Africa .

Access to screening, diagnosis and early treatment with HIV drugs is limited in many poorer nations, but in wealthy countries like Britain their availability has made a big difference to many patients' lives.

Gompels worked with Margaret May of Bristol University and used data from the UK Collaborative HIV Cohort study, which in 2001 began collating routine data on HIV positive people who had been attending some of Britain 's largest clinics since January 1996.

They looked at patients aged 20 and over who started treatment with at least three HIV drugs between 1996 and 2008.

Their analysis showed that life expectancy for an average 20-year-old infected with HIV increased from 30 years to almost 46 between the periods 1996 to 1999 and 2006 to 2008.

"We should expect further improvements for patients starting antiretroviral therapy now with improved modern drugs and new guidelines recommending earlier treatment," May said in a statement about the work.

The findings also showed that life expectancy for women treated for HIV in Britain is 10 years higher than for men.

During the period 1996 to 2008, life expectancy was 40 years for male patients and 50 years for female patients, compared with 58 years for men and nearly 62 years for women in the general UK population.

In a comment on the findings, Elena Losina, a senior scientist at the Boston Brigham and Women's Hospital in the United States said that although the progress in Britain was encouraging, it should also serve as "an urgent call" to increase awareness among patients and health workers about how effective HIV treatment can be -- especially if started early.

"In turn this should increase rates of routine HIV screening, with timely linkage to care and uninterrupted treatment," she said. "As these factors improve, the full benefits of treatment for all HIV infected people can be realised." (Editing by Rosalind Russell)

 


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