New EACS guidelines address co-morbidities and diseases of age

Gus Cairns
Published: 16 November 2009

The 2009 Treatment Guidelines published by the European AIDS Clinical Society (EACS) are considerably longer and more detailed than the last set, published in 2007. The 80-page booklet adds a number of guidelines for treating 14 different co-morbidities and co-infections.

Dr Nathan Clumeck of Brussels University, presenting the guidelines at the 12th European AIDS Conference, commented that most of the co-morbidities included in the new sections were diseases associated with age.

The last guidelines were published in 2007 - see this report - and their new sections on management of metabolic issues and on hepatitis co-infection were innovations in HIV guidelines at the time.

The new co-morbidity section includes guidelines on cancer screening, cardiovascular disease prevention, high blood pressure, diabetes, bone mineral loss, depression, hyperlactataemia, renal toxicity, lipodystrophy, and diagnosis of high liver enzymes. It also adds a section on HIV therapy for patients with TB, expands the section on hepatitis B, and adds a section on delta hepatitis infection (HDV).

The antiretroviral (ARV) guidelines, as well as including a new TB section, add a section on switching therapy in patients who are virologically suppressed.

They also add at the beginning an algorithm, already included in the internet version of the 2007 guidelines, for ensuring that patients are ready to start therapy.

Most other changes in the ARV section are ones of emphasis rather than substance. Treatment is now ‘recommended’, rather than ‘may be offered’, for patients with CD4 counts between 350 and 500 if they have hepatitis C, active hepatitis B or HIV-associated kidney disease; and treatment ‘should be considered’ in patients with viral loads over 100,000 copies/ml3, with a CD4 loss of more than 50 cells/mm3 a year, or who are pregnant, have cancer, or have a high cardiovascular disease risk.

Boosted darunavir and atazanavir have been added to recommended starting regimens and boosted fosamprenavir and raltegravir as alternatives; the guidelines were written before the European Medicines Agency licensed raltegravir for naive use in September.

The ‘HAART and TB’ section recommends that TB patients with CD4 counts under 100 cells/ml3 should start ARVs straight away but that patients with CD4s between 100 and 350 can wait till completing two months of TB therapy.

The new section of switching in virally-suppressed people covers switching for drug interactions, toxicity and simplification. It recommends that switching under these circumstances should only be considered for patients with no history of treatment failure.

When asked if this was unduly restrictive, Dr Anton Pozniak of the Chelsea and Westminster Hospital, London, commented that the guidelines were intended for a variety of resource settings and that baseline resistance tests were not available to guide clinicians in many European countries.

As reported elsewhere, the guidelines suggest that protease inhibitor monotherapy “might represent an option with intolerance to NRTIs or for treatment simplification, but only applies to patients without a history of failure”.

Dr Clumeck, commenting on the addition of ‘generally’ to the sentence that therapy should not generally be offered to patients with CD4 counts over 500, said that nearly all of his patients who had asked for early therapy had been in couples.

“If they have a partner and they are ready to start, why shouldn’t they?” he said, “Of course, for the patient themselves, but also in order to protect transmission – though I am aware this is a hot issue.”

Dr Manuel Battegay of the University of Basel commented that requests for early treatment were rare; in general patients wanted to put off treatment. Anton Pozniak added: “If we get more data that untreated HIV will lead to physiological ageing, then the message that HIV treatment will keep you young will be a powerful one”.

Dr Jens Lundgren of the University of Copenhagen introduced the co-morbidity guidelines. He described them as “preventative or management principles other than the use of ARVS and other anti-infectious agents”.

Cancer screening recommendations cover breast cancer in women aged 50-70, cervical cancer in sexually active women, anal cancer in gay men, colorectal cancer in patients between 50 and 75, and prostate cancer in men over 50.

The section on prevention of cardiovascular disease previously just covered heart disease, but sets tighter restrictions on when to switch therapy for CVD risk.

The list of recommended statins is changed in cases of high cholesterol, and in the absence of evidence that anything works well, there is now no recommendation for a treatment to manage high triglycerides.

Diabetes management recommends metformin as the first drug of choice if lifestyle changes cannot control blood sugar.

The guidelines now recommend that all patients should receive baseline screening for kidney disease and recommends specific treatment protocols for different rates of impairment.

For bone mineral loss, it recommends the use of an online algorithm called FRAX which calculates the 10-year risk of fractures in a way similar to the Framingham heart-disease 10-year risk algorithm.

Depression is the first psychological condition to be included as a co-morbidity and the guidelines recommend a simple two-question test on mood and motivation which has a 60% sensitivity for depression.

Nathan Clumeck commented that the co-morbidity section is “now the most important part of guidelines. We now recommend ART for the long-term and for most patients; now we have to manage long-term toxicity and conditions of ageing”.

Jens Lundgren said that “In the general population, if you follow these simple guidelines you can reduce the risk of cardiovascular disease by 70-80%. It does however require action by both doctor and patient”.

Alexey Kruk, a physician from Russia commented that the guidelines “will be a way forward in my country, persuading physicians to treat patients well”.

For the hepatitis section Sanjay Bhagani of the Royal Free Hospital said that the guidelines now recommended that all HIV patients should be screened for hepatitis C at diagnosis and then regularly according to risk. “Acute HCV is increasing by leaps and bound in HIV-positive gay men,” he said.

The guidelines now include a section on hepatitis delta (HDV). This parasitic virus can only infect people who have chronic hepatitis B (HBV), but the 5-15% of HBV patients who do have it suffer an eightfold higher rate of fibrosis progression. All HIV patients should be screened for HDV antibodies and it should be especially suspected in a patient who is developing fibrosis despite having a low HBV viral load.

The guidelines now recommend that patients with chronic HBV should start a tenofovir-including ARV regimen at a CD4 count of 500 cells/mm3.

There were a few criticisms. Dr Giovanni Guaraldi from Modena, Italy said he felt that the standard Framingham algorithm might underestimate the risk of HIV-related inflammatory processes which cause damage to blood vessels.

Cancer specialist Dr Mark Bower welcomed the inclusion of anal cancer screening but said that there was a worldwide shortage of specialists in anoscopy to perform the tests.

And bone specialist Christophe Fux said that the algorithm to estimate fracture risk may underestimate risks in people with HIV for the same reasons as the heart attack algorithm.

But patient representative Simon Collins commented that since most of these areas relate to conditions of ageing, we will see more evidence accumulating.

“A lot of work went into these guidelines,” he said. They’re a really impressive attempt to normalise and standardise patient care over Europe.”

For the Guidelines, see www.europeanaidsclinicalsociety.org/guidelines.asp