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)?
- 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.
- 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.
How to apply for participation
What is dolutegravir?