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HIV: the almost as safe alternate treatments that continued therapy in patients caught early

Interruptions of anti-HIV therapy guided by CD4 cell counts are relatively as safe as continuous therapy when performed in patients developed early antiretroviral therapy, say Spanish researchers in a study published in Aids.

The treatment interruption strategy is one of the avenues explored to decrease in HIV + patient's weight therapy for life, particularly in terms of side effects.

Despite several promising results, this research is marked by the failure of the broad international SMART study, interrupted in January 2006 due to mortality and more than two times higher morbidity in patients alternate treatment.

Lidia Ruiz, from the Autonomous University of Barcelona (Spain) and colleagues in their study confirm any safety of this strategy, based like the SMART CD4, suggesting it could be as safe ascontinuous therapy in patients caught early.

Compared to 101 people under continuous treatment, 100 patients in the study arms, including CD4 early test was greater than 500 cells / ml and undetectable viral load (less than 50 copies / ml), debuted the test by stopping their antiretrovirals.

They rebuked when their CD4 down below 350 copies / ml when viral load exceeded 5 log10 copies / ml at the onset of AIDS defining event. The treatment was interrupted again when their CD4 count exceeded 500 cells/mm3 and viral load down to below 50 copies / ml.

But unlike the SMART trial, the rate of recovery and treatment discontinuation were lower (250 and 350 cells/mm3, respectively), Spanish researchers noted no deaths or AIDS defining event in any two arms, and at 96 weeks.

Only one episode of oral candidiasis and two herpes virus infections (one off treatment period, the other antiretrovirals) were identified in the study arms. However, the researchers noted a higher frequency of mononucléosiques symptoms (fatigue, fever, headache, cough, myalgia, etc ...) that under continuous treatment (0.56 against 0,025 person-years).

According to expectations, researchers update lower CD4 counts in patients of the study group, 520 cells/mm3 against 789 cells/mm3 at 96 weeks. Nearly one in ten patients (9.1%) has a CD4 count below 350 cells/mm3, against 1% in the control group.

End of the test, the viral load is itself of 4.33 log10 copies / ml, against 1.7 log10 copies / ml (50 copies / ml).

The results of the study arms is also less favorable in terms of resistance to antiretroviral drugs, including non-nucleoside reverse transcriptase inhibitors (NNRTIs), more frequent in the alternate treatment.

However, researchers detect nuances between patients. Thus, those whose nadir CD4 count is below 350 cells/mm3 and those who initiated their therapy with a viral load exceeding 100,000 copies / ml, respectively 2 and 3.76 times more likely to remain low off-time processing.

The authors consider as "strategy interruption guided by CD4 count is not as safe as continuous therapy, with the possible exception of patients whose nadir is above 350 cells/mm3 and whose the pretreatment viral load below 50,000 copies / ml. "

"Stricter thresholds during therapy reinitiation CD4, for example 500 cells/mm3 [instead of 350 cells/mm3], can improve the safety of this approach, while allowing some patients to reduce their antiretroviral exposure, "they conclude.

Another strategy that guided by the CD4 count is, namely fixed periods. It is being studied in the trial Franco-Ivorian TRIVACAN whose arm interrupt determined by CD4 as SMART, was discontinued due to increased mortality and morbidity.