Monday, March 05, 2012

ViiV Announces Expanded Access of New Integrase Inhibitor...But Activists Are Concerned About Its Potential Misuse


By on 8:43 PM


The dolutegravir expanded access program (EAP) has been designed to provide free access to Shionogi-ViiV Healthcare’s investigational integrase inhibitor, dolutegravir (DTG, S/GSK1349572) in an open-label protocol program to adults living with HIV who have documented raltegravir or elvitegravir resistance, who have limited treatment options, and who require DTG to construct a viable antiretroviral regimen for therapy. The dose is 50 mg twice a day for patients with multi drug resistance (the drug will also be eventually approved for once daily use for treatment naive patients)

But before you consider the use of this new drug, read the following warning: Activists Advise Caution About Access Program

Who can participate in the dolutegravir EAP (ING114916)?

The dolutegravir EAP is available to adults living with HIV who (Note: Not all inclusion criteria are listed):
  • Are male or female age 18 years or older (female patients of child-bearing potential should use every precaution to prevent pregnancy)
  • Have documented plasma HIV-1 RNA levels ≥400 copies/mL within 3 months prior to the screening visit
  • Have documented raltegravir or elvitegravir resistance
  • Are unable to construct a viable background regimen of anti-retroviral therapy with commercially available medications.
The dolutegravir EAP is not available to adults living with HIV who (Note: Not all exclusion criteria are listed):
  • Have estimated creatinine clearance (CrCl) <30 mL/min
  • Are pregnant or breastfeeding
  • Have had a known or suspected allergic reaction to an integrase inhibitor
  • Have an alanine aminotransferase (ALT) level >5 times the upper limit of normal (ULN)
  • Have an ALT >3 times ULN and total bilirubin >1.5 times ULN
  • Have evidence of severe hepatic impairment
  • Are eligible for, and have access to, an actively enrolling DTG Phase III clinical trial
  • Have any condition (including but not limited to alcohol and drug use) or any active clinically significant disease or findings during screening of medical history or physical examination, which, in the opinion of the treating physician would interfere with safety or compliance
  • Requires or is anticipated to require any of the prohibited concomitant therapy.
*Please note: country specific criteria may also apply.
The dolutegravir EAP is now open and accepting participants in the USA and Canada.
For Europe and the International region, it's expected that the EAP will start to open in March/April 2012 as local regulatory and ethics approvals are obtained.

How to apply for participation

For adults living with HIV: Please discuss your possible participation with your healthcare professional. If the EAP is available in your country, check with your healthcare provider if he or she is a participating site. If not, your healthcare provider may contact PAREXEL for further details on how to access the program.
For healthcare professionals treating HIV: If you have an eligible patient(s), please contact PAREXEL at dolutegravir-eap@parexel.com for further details about the program.

What is dolutegravir?

Dolutegravir (DTG, GSK1349572) is an integrase inhibitor under development as a treatment for HIV-1 infection. Phase III studies to assess the safety and efficacy of dolutegravir in antiretroviral naïve and experienced adults living with HIV are currently underway. The safety and efficacy of dolutegravir has not yet been fully established or thoroughly evaluated by regulatory agencies.

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