"These guidelines clearly set more ambitious goals for the management of treatment-experienced patients now that we have potent therapies such as the combination of tipranavir and enfuvirtide," commented Dr Anton Pozniak, Chelsea and Westminster Hospital, London. "These guidelines provide real clarity and much needed direction on how to best care for pre-treated patients."
The DHHS recommendation reflects the growing body of evidence for the powerful "FUZEON effect" which has been seen across the RESIST 1 & 2, POWER 1 & 2 and TORO 1 & 2 studies. These studies showed that adding FUZEON almost doubled the number of patients reaching undetectable, when combined with one of the latest boosted protease inhibitors (PI) such as lopinavir, tipranavir or TMC 114.
The guidelines recommend the treatment goal of achieving the suppression of the virus to levels that make it undetectable in the blood, for treatment-experienced patients who show some drug resistance but still have some active antiretroviral agents available. An active drug is one that is still effective against the virus.
Notes to Editors:
Recommendations -The updated DHHS guidelines (October 6, 2005) are available online: http://aidsinfo.nih.gov/guidelines/.
The Panel on Clinical Practices for Treatment of HIV Infection of the US Department of Health and Human Services (DHHS) focuses on the overall management of treatment-experienced patients. It also provides guidance on changing an antiretroviral therapy regimen for virologic failure, for which the latest recommendations include:
- Using the treatment history and past and current resistance test results to identify active agents (preferably at least two fully active agents) to design the new regimen. A fully active agent is one likely to demonstrate antiretroviral activity on the basis of both the treatment history and susceptibility on drug-resistance testing.
- Adding a drug with activity against drug-resistant virus (e.g. a potent ritonavir-boosted PI) and a drug with new mechanism of action (e.g. HIV entry inhibitor) to an optimised background antiretroviral regimen can provide significant antiretroviral activity.
Growing Body of Evidence, RESIST 1&2 / POWER 1 & 2/ TORO 1& 2 - Collectively the data from all six studies, in over 2,500 patients, establish a new paradigm in the management of triple class-experienced patients. Latest data adds to growing Body of Evidence – Latest Boosted Protease Inhibitors (lopinavir/r, tipranavir/r and TMC 114/r) all work best in combination with FUZEON.
RESIST Phase III tipranavir trials
- Over 24 weeks, almost double the proportion of patients who received FUZEON plus boosted tipranavir showed a 90% drop in viral load compared with patients not receiving FUZEON
POWER Phase II TMC114 dosing trials
- Over 24 weeks in the combined TMC114 trials, almost double the proportion of patients who received FUZEON plus boosted TMC114 achieved a viral load below 50 copies/ml compared with patients not receiving FUZEON
- A remarkable 67% of the patients receiving FUZEON plus boosted TMC114 reached an undetectable viral load
TORO Phase III FUZEON trials
- Over 24 weeks, double the proportion of patients who received FUZEON plus boosted lopinavir achieved an undetectable viral load (<50 copies/ml) compared with patients not receiving FUZEON
The boosting of PIs is a therapeutic strategy wherein a small dose of ritonavir is given concurrently with another PI to pharmacologically enhance exposure to the latter PI through the inhibition of the enzyme cytochrome p450. Ritonavir boosting results in improved drug levels that can increase efficacy, decrease pill burden, add flexibility to the dosing schedule, and remove fasting restrictions
Efficacy and Durability
The 96 week FUZEON data confirm that FUZEON based regimens continue to provide a significant, durable response to pre-treated HIV patients over two years of treatment. The safety profile was confirmed with no changes in the adverse event profile between one and two years of therapy. Consistent and continuous improvements in immune strength were seen in FUZEON patients over 96 weeks. FUZEON patients remained twice as likely to show undetectable HIV as those patients who did not receive FUZEON. In addition, more than half of patients who received FUZEON completed two years of treatment.
Safety of FUZEON
FUZEON is administered as a twice-daily subcutaneous injection. Local injection site reactions were the most frequent adverse events associated with the use of FUZEON. In the TORO studies, 98 percent of patients had at least one local injection site reaction over the course of 48 weeks. In this treatment-experienced patient population, 4 percent of patients at 48 weeks discontinued treatment with FUZEON as a result of injection site reactions.
An increased rate of some bacterial infections, primarily pneumonia, was seen in patients treated with FUZEON. It is unclear if this increased incidence is related to FUZEON use. The addition of FUZEON to background antiretroviral therapy generally did not increase the frequency or the severity of the majority of adverse reactions. The majority of adverse reactions were of mild or moderate intensity. Hypersensitivity reactions have occasionally been associated with FUZEON therapy and in rare cases have recurred on re-challenge.
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