Compassionate use access to fostemsavir (GSK3684934, formerly BMS-663068) for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are experiencing virologic failure and are unable to comprise a suppressive regimen with currently available antiretrovirals.
Direct inquires to the ViiV Compassionate Use Portal via https://viiv-cu-portal.idea-point.com/
Patient has given consent for treatment
Patient is male or non-pregnant female, age 18 years and older. NOTE: there may be allowance for a lower minimum age if dictated by local regulatory and/or legal requirements.
Patient has chronic HIV-1 infection and is heavily treatment experienced
is unable to comprise a suppressive regimen without fostemsavir due to documented multi-drug resistance test results and/or intolerance and/or contraindication AND
Patient is eligible to access commercial fostemsavir or investigational fostemsavir by means other than the named patient program.
strong CYP3A inducers including, but not limited to: carbamazepine, phenytoin (anticonvulsants), mitotane (antineoplastic), enzalutamide (androgen receptor inhibitor), rifampicin (antimycobacterial) and St John's wort (Hypericum perforatum, herbal supplement),
elbasvir/grazoprevir (hepatitis C direct acting antiviral)
Patient has a prior history of poor adherence with multiple failed attempts of oral ART
Fostemsavir
DrugFostemsavir 600 mg extended release tablets, administered 600 mg twice daily, will be supplied for compassionate use for the identified individual patient.
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