RE:RE:PLWH have twofold risk of liver fibrosis They said initially min 50 HIV cohorts will be included in the trial.
As per their estimates some 20% in the US suffer from NAFLD and 3 to 12% from NASH in the US .
As per global liver institute/NASH council the comorbidity of none adavanced NASH and other conditions such as diabetes type 2 increased the cost to US healthcare in 2017 from $222 billion to $667 billion!
The prevalence of liver fibrosis in PLWH is estimated between 8 to18%.
Point is the condition is lethal, with growing prevalence, underestimated and costs billions also more progressive/common in PLWH so I am pretty sure the agencies will be open to label extention and that's why the trial is including HIV patients.
palinc2000 wrote: Do you recall how big the subgroup of Hiv patiemnts will be included in the Nash trial?I think there could be a chance that FDA could allow a Label Extension for Nash HIV patients when the DSMB carries oiut an interim review .....Am I dreaming?