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Reged: 09/25/02
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CROI: Treatment Interruption Appear Safe for Selec
      #59142 - 02/19/03 03:07 AM

CROI: Treatment Interruption Appear Safe for Selected Patients

By Charlene Laino

BOSTON, MA -- February 17, 2003 -- Many HIV-infected patients with well controlled viral loads and CD4 counts on highly active antiretroviral therapy (HAART) can safely go on a "drug holiday," a new study suggests.

Luis Ruiz, MD, from the IrsiCaixa Foundation and Lluita Contra la SIDA Foundation in Barcelona, Spain, presented the findings here on February 10th at the 10th Conference on Retroviruses and Opportunistic Infections.

Although current guidelines recommend that patients remain on HAART for life, Dr. Ruiz contends that treatment interruptions guided by CD4 cell count and viral load may safely minimize drug-associated toxicity.

The multicenter, open-label clinical trial enrolled 122 patients with viral load levels below 80 copies/mL for at least 1 year and CD4 counts of at least 500 cells/mm3 for at least 6 months. They were randomised to continue their existing treatment (n=61) or to interrupt therapy (n=61). CD4 cell counts and viral load levels were measured monthly in the patients on interrupted therapy.

For those randomised to the treatment interruption arm, a viral load increase of 100,000 copies/mL or more, a drop of CD4 cell count below 350 /mm3, or the appearance of any opportunistic infection prompted re-initiation of HAART. If the CD4 count subsequently rose to 500 cells/mm3 or above, and viral load fell below 80 copies/mL, the patients could again discontinue HAART.

For patients who remained on HAART, all except two maintained undetectable viral loads, and median CD4 cell counts remained stable at a median of 804 /mm3. In the treatment interruption group, 43% of patients remained off therapy for at least 48 weeks. For these patients, the median viral load was 4.1 log copies/mL, and CD4 cell count fell a median of 335 cells/mm3, or 33 cells/mm3/month.

For those who resumed HAART, the median time off therapy was 8 weeks. Among these, 96% re-initiated HAART because of viral load levels that rose more than 100,000 copies/mL. Those in the interrupted therapy arm also demonstrated a median reduction in CD4 cells of 96 cells/mm3/month. Ten percent of those who discontinued therapy experienced an acute retroviral syndrome. No patients developed opportunistic infections or tumors during the study period.

Because the findings suggest that 43% of carefully selected patients can remain without therapy for 48 weeks, treatment interruption may be an important strategy for reducing toxicity due to HAART over the long run, Dr. Ruiz concluded.

[Study title: Multi-center, Randomized Controlled Clinical Trial of Continuous vs Intermittent HAART Guided by CD4+ T-cell Counts and Plasma HIV-1 RNA Levels]

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Re: CROI: Treatment Interruption Appear Safe for Selec new
      #59190 - 02/19/03 03:46 PM

Thanks for the information. It is a good thing to here.Let us all hope to here more good things like this.

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Reged: 10/26/00
Posts: 2028
Re: CROI: Treatment Interruption Appear Safe for Selec new
      #59230 - 02/20/03 01:06 PM

I talked my doctor into that again a few months ago. So far, so good. I do have to have my blood work done every month. My last counts were VL 900 and CD4 over 700. That's after 2 months off. I also had a drug holiday years ago. When I first learned I was positive, the theory was to 'hit hard, hit early'. About a year after starting meds I stopped. I just couldn't handle getting the Saquinivir down and got to the point I couldn't swallow any pills without gagging. He wasn't happy, but put up with it. I was able to stay off for a year and half. Maybe it was because I was started on meds early. Maybe because my set point was about 30,000. Who knows.

What I do know is that it's nice to have a break, but it's also nice to know medications are there when I need them again.

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