User login
GENEVA — Giving HIV-infected patients a holiday from their drugs may safely reduce the side effects and costs of treatment, according to results from the Staccato study, a prospective, open-label, randomized trial done in Thailand, Switzerland, and Australia.
Interruption of treatment with highly active antiretroviral therapy (HAART) according to a subject's CD4+ cell count led to substantial drug savings and reduced the side effects of treatment but did not raise the risk of increased immune suppression or emergence of resistance (Lancet 2006;368:459–65).
Lifelong treatment with HAART is extremely effective in controlling HIV and has significantly improved AIDS-free survival since its introduction in 1996. However, HAART is expensive and also can lead to troublesome side effects.
To evaluate the safety of interrupting HAART, the Staccato investigators randomized 430 patients who had CD4 counts greater than 350 cells/microliter and HIV RNA less than 50 copies/milliliter for at least 3 months prior to study entry to either continued therapy (n = 146) or scheduled treatment interruptions (n = 284) for a median of 21.9 months (range 16.4–25.3 months).
Initially, the Staccato trial attempted to assess the safety of interruption therapy of 1 week on/1 week off. However, an interim analysis of this strategy found an unacceptably high rate of failure, and this arm was discontinued, wrote senior author Dr. Bernard Hirschel, chief of the HIV/AIDS division, Geneva University Hospital, Geneva, and his associates.
All patients were monitored for CD4 count, viral load, adverse events, and HIV disease progression. Patients in the scheduled treatment interruption group began the trial by discontinuing HAART. If their CD4 count dropped below 350 cells/microliter on two consecutive measures, they resumed HAART for at least 12 weeks. They stopped again if their CD4 count rose above 350 cells/microliter.
Results at the end of the study showed that HIV control was similar in both groups, with 90.5% of patients in the interrupted group and 91.8% of patients in the continuous treatment group achieving HIV RNA less than 50 copies/milliliter.
Patients in the interruption group had more oral and genital candidiasis, but they also had a moderate decrease in such treatment-related adverse events as diarrhea and lipodystrophy, the researchers wrote.
“The results provide reassurance about the one risk that was feared—development of resistance and loss of efficacy of treatment,” Dr. Hirschel said in a statement. “Scheduled treatment interruptions, lasting many months, with substantial drug savings, can be anticipated, particularly in patients whose immune systems were never damaged by HIV.”
GENEVA — Giving HIV-infected patients a holiday from their drugs may safely reduce the side effects and costs of treatment, according to results from the Staccato study, a prospective, open-label, randomized trial done in Thailand, Switzerland, and Australia.
Interruption of treatment with highly active antiretroviral therapy (HAART) according to a subject's CD4+ cell count led to substantial drug savings and reduced the side effects of treatment but did not raise the risk of increased immune suppression or emergence of resistance (Lancet 2006;368:459–65).
Lifelong treatment with HAART is extremely effective in controlling HIV and has significantly improved AIDS-free survival since its introduction in 1996. However, HAART is expensive and also can lead to troublesome side effects.
To evaluate the safety of interrupting HAART, the Staccato investigators randomized 430 patients who had CD4 counts greater than 350 cells/microliter and HIV RNA less than 50 copies/milliliter for at least 3 months prior to study entry to either continued therapy (n = 146) or scheduled treatment interruptions (n = 284) for a median of 21.9 months (range 16.4–25.3 months).
Initially, the Staccato trial attempted to assess the safety of interruption therapy of 1 week on/1 week off. However, an interim analysis of this strategy found an unacceptably high rate of failure, and this arm was discontinued, wrote senior author Dr. Bernard Hirschel, chief of the HIV/AIDS division, Geneva University Hospital, Geneva, and his associates.
All patients were monitored for CD4 count, viral load, adverse events, and HIV disease progression. Patients in the scheduled treatment interruption group began the trial by discontinuing HAART. If their CD4 count dropped below 350 cells/microliter on two consecutive measures, they resumed HAART for at least 12 weeks. They stopped again if their CD4 count rose above 350 cells/microliter.
Results at the end of the study showed that HIV control was similar in both groups, with 90.5% of patients in the interrupted group and 91.8% of patients in the continuous treatment group achieving HIV RNA less than 50 copies/milliliter.
Patients in the interruption group had more oral and genital candidiasis, but they also had a moderate decrease in such treatment-related adverse events as diarrhea and lipodystrophy, the researchers wrote.
“The results provide reassurance about the one risk that was feared—development of resistance and loss of efficacy of treatment,” Dr. Hirschel said in a statement. “Scheduled treatment interruptions, lasting many months, with substantial drug savings, can be anticipated, particularly in patients whose immune systems were never damaged by HIV.”
GENEVA — Giving HIV-infected patients a holiday from their drugs may safely reduce the side effects and costs of treatment, according to results from the Staccato study, a prospective, open-label, randomized trial done in Thailand, Switzerland, and Australia.
Interruption of treatment with highly active antiretroviral therapy (HAART) according to a subject's CD4+ cell count led to substantial drug savings and reduced the side effects of treatment but did not raise the risk of increased immune suppression or emergence of resistance (Lancet 2006;368:459–65).
Lifelong treatment with HAART is extremely effective in controlling HIV and has significantly improved AIDS-free survival since its introduction in 1996. However, HAART is expensive and also can lead to troublesome side effects.
To evaluate the safety of interrupting HAART, the Staccato investigators randomized 430 patients who had CD4 counts greater than 350 cells/microliter and HIV RNA less than 50 copies/milliliter for at least 3 months prior to study entry to either continued therapy (n = 146) or scheduled treatment interruptions (n = 284) for a median of 21.9 months (range 16.4–25.3 months).
Initially, the Staccato trial attempted to assess the safety of interruption therapy of 1 week on/1 week off. However, an interim analysis of this strategy found an unacceptably high rate of failure, and this arm was discontinued, wrote senior author Dr. Bernard Hirschel, chief of the HIV/AIDS division, Geneva University Hospital, Geneva, and his associates.
All patients were monitored for CD4 count, viral load, adverse events, and HIV disease progression. Patients in the scheduled treatment interruption group began the trial by discontinuing HAART. If their CD4 count dropped below 350 cells/microliter on two consecutive measures, they resumed HAART for at least 12 weeks. They stopped again if their CD4 count rose above 350 cells/microliter.
Results at the end of the study showed that HIV control was similar in both groups, with 90.5% of patients in the interrupted group and 91.8% of patients in the continuous treatment group achieving HIV RNA less than 50 copies/milliliter.
Patients in the interruption group had more oral and genital candidiasis, but they also had a moderate decrease in such treatment-related adverse events as diarrhea and lipodystrophy, the researchers wrote.
“The results provide reassurance about the one risk that was feared—development of resistance and loss of efficacy of treatment,” Dr. Hirschel said in a statement. “Scheduled treatment interruptions, lasting many months, with substantial drug savings, can be anticipated, particularly in patients whose immune systems were never damaged by HIV.”