aren't doctors trying to treat with this Remune to delay ARV treatment?
Oct 15, 2004
Why Aren't doctors in the United States treating with remune first to delay treatment to ARVs. Isn't there any promise of new evidence that this might be beneficial?
Long-term Treatment with Remune® Delays Progression to AIDS in Thai Volunteers
The aim of this study was to observe the long-term effects of an immune-based therapy HIV-1 Immunogen (REMUNE®; Immune Response Corp., Carlsbad, CA, USA) as a first course of treatment designed to sustain the immune system and thus delay the initiation of therapy with antiretroviral drugs and/or delay disease progression.
In this open-label, multi-institute extended phase II P2101B study, disease progression, CD4 and CD8 T-cell counts, HIV-1 RNA levels, and genotypic antiretroviral drug resistance were examined in 223 asymptomatic HIV-1-infected
Thai volunteers receiving REMUNE® every 12 weeks over 132 weeks. A subset of subjects was randomly selected by the physicians to receive antiretroviral drugs for 10 months.
Patients treated with REMUNE® demonstrated a low rate of clinical disease progression (0.72 per 100 person-years), higher CD4 and CD8 T-cell counts, higher body weight before and after treatment in the same patient, and stable viral load with no serious adverse events.
The investigators found no genotypic evidence of drug resistance in subgroups of patients on REMUNE® monotherapy or REMUNE® plus antiretrovirals (ARTs).
This Thai study, like previous US and European studies, confirms that therapeutic immunization of HIV-infected volunteers modifies disease progression, as evidenced by stabilization of CD4 and CD8 T-cell counts, body weight, and viral load.
As the majority of asymptomatic patients demonstrated an objective response to immunization, this study suggests that REMUNE® may be utilized prior to initiation of antiviral drug therapy when CD4 cell counts are still above the current ART guidelines.
Further work should be carried out to examine its potential use in combination with ART in order to reduce the increasingly common occurrence of drug resistance.
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Reference W Chantratita and others. Delayed progression to AIDS in volunteers treated with long-term HIV-1 Immunogen (REMUNE®) therapy in Thailand. HIV Medicine 5(5): 317. September 2004.
Response from Dr. Henry
Good question. The data clearly showing a benefir from Remune is not very convincing and is controversial. Much of the positive data seems to come from the company that makes it. A large study looking at antiretroviral therapy + Remune versus antiretroviral therapy alone showed no benefit. A recent in the journal HIV Medicine (2004 volume 5 pp 317-325)purported to show a benefit but was not convincing with no good control group. The patients did not do as well as one would expect on antiretroviral therapy. That study looked at a group with a low CD4 count. I would be more interested in seeing a study done with higher CD4 counts (ie > 350-500) comparing Remuneor a more effective vaccine to placebo along the idea of your question-so far no study like that has shown much effectiveness or hasn't been done. KH
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