European AIDS Clinical Society Issues New Guidelines for Management of HIV

Becky McCall

November 18, 2009

November 17, 2009 (Cologne, Germany) — New European AIDS Clinical Society (EACS) guidelines recommend that clinicians begin treatment of HIV-positive patients earlier, when CD4 cell counts are 350 to 500 cells/mL, to improve long-term outcomes and minimize comorbidities.

The updated Clinical Management and Treatment of HIV-Infected Adults in Europe guidelines were announced here at the EACS' 12th European AIDS Conference. Committee members drew attention to key changes relating to in which stage of disease to commence treatment, new drug recommendations in naive HIV-infected patients, and new drug treatment recommendations for individuals coinfected with hepatitis B, hepatitis C, and tuberculosis.

"With these guidelines, we pushed the limit of treatment to 350 to 500 cells/mL due to the availability of new data which suggests treating patients in this group has a positive impact on their future as far as cardiovascular disease,...aging, neuropsychological disturbances, and other comorbidities go," said executive guidelines committee member Nathan Clumeck, MD, head of the Department of Infectious Diseases at St. Pierre University Hospital, Brussels, Belgium, and head of the working group on antiretroviral therapy.

Dr. Clumeck explained that changes had been made in light of new trends about when to start therapy and when to treat with new drugs. "Bearing in mind there are lots of new drugs coming onto the market, guidance is needed on how to make the right choice for which indication."

Echoing the message of the HIV in Europe Initiative, Dr. Clumeck stressed that too many patients were commencing treatment too late, when the CD4 count is lower than 200 cells/mL. The guidelines may encourage more HIV-positive patients to be treated earlier. "Previously, formal recommendations were to treat at a CD4 count of less than 350 cells/mL, but now we know there is a clear advantage to treat between 350 and 500 cells/mL to help preserve the patient's future. In Europe, too many patients are late presenters, so there is a lot of work to do," he noted.

Two recommendations concerning first-line drug use have been added to the guidelines. For naive HIV-infected patients, the new protease inhibitor darunavir [Prezista, Tibotec Pharmaceuticals] is recommended. "Darunavir is very active on multiresistant virus, and the data indicates it is superior to other protease inhibitors, especially over the most commonly used lopinavir/ritonavir [Kaletra, Abbott]. This is why we have escalated darunavir as a recommended protease inhibitor," Dr. Clumeck told Medscape HIV/AIDS.

Dr. Clumeck added that very recent trial results for atazanavir (Reyataz, Bristol-Myers Squibb) show that this protease inhibitor is better tolerated than lopinavir/ritonavir in naive HIV-infected patients. "Atazanavir has been shown to be not inferior to lopinavir/ritonavir...but tolerance at the gastrointestinal and lipid level is improved, which it is why it is now recommended as a first-line regimen."

Finally, raltegravir (Isentress, Merck & Co), which derives from the new class of integrase inhibitors, has currently been added as an alternative treatment option in naive HIV-infected patients. Raltegravir inhibits the virus at a totally different site than inhibitors of reverse transcriptase or protease and is very effective and been shown to be noninferior to efavirenz (Sustiva, Bristol-Myers Squibb). "The only reservation is that raltegravir is weak at the virus-resistance level. If it is not given in combination with another drug, then resistance emerges rapidly. Because we still lack long-term data, we have added raltegravir as an alternative at the moment, but it may be upgraded in the future," said Dr. Clumeck.

Sanjay Bhagani, MD, consultant in infectious diseases from the Royal Free Hospital, London, United Kingdom, presented the new EACS treatment guidelines on hepatitis B (HBV) and hepatitis C (HCV) coinfections. "The biggest change this time around is in the management of HBV in HIV-infected patients. Previously, we recommended use of HBV nucleoside analogues, which are HBV-active but which are not HIV-active, based on an old CD4 count [treatment initiation] recommendation of 350 cells/mL. But we now recommend that if the patient's CD4 count is less than 500 cells/mL, then highly active antiretroviral therapy (HAART) should be started with agents that have activity against HBV. If the count is above 500 cells/mL and the patient also has HBV, then we also recommend that these patients receive HAART."

Recommendations on the use of non-HIV active nucleosides and nucleotides have been removed because there are concerns that these drugs have limited activity against HIV but just enough activity to introduce resistance.

Fewer changes were made to treatment recommendations for HCV, except for acute HCV infection, which is increasing in incidence. The guidelines recommend that these patients should be treated as soon as possible after diagnosis and at least within the first 6 months. However, there is a lack of randomized controlled trial data referring to which drugs may be preferable as initial treatment. Earlier use of HAART in HCV/HIV coinfected patients with a high CD4 count is now recommended.

The new EACS treatment guidelines for HIV-infected patients coinfected with tuberculosis call for the early use of ART for HIV, despite coinfection. "The question has always been, When do you start patients on treatment for tuberculosis when they are also on ART? There are trials planned in the next few years, but in the meantime, the guidelines suggest that if a patient's CD4 count is less than 100 cells/mL, then ART should be started as soon as feasible because the patient is at greater risk for other opportunistic infections. Between a CD4 count of 100 and 350 cells/mL, it is left to the discretion of the physician, and if over 350 cells/mL, then ART could probably wait until after tuberculosis treatment is complete," Dr. Bhagani added.

The guidelines are available on the EACS Web site.

Dr. Clumeck and Dr. Bhagani have disclosed no relevant financial relationships.

12th European AIDS Conference/European AIDS Clinical Society: Parallel Session 7. Presented November 13, 2009.

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