AbbVie’s “3D” regimen cured high rates of genotype 1 of hepatitis C virus (HCV) among people coinfected with HIV. Reporting their findings at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, investigators conducted the first of two parts of the TURQUOISE trial, a multicenter Phase II/III study of people with genotype 1 of hep C who were coinfected with HIV, including those with cirrhosis.
The 3D regimen is comprised of a fixed-dose combination of the protease inhibitor ABT-450 and ritonavir coformulated with the NS5A inhibitor ombitasvir (ABT-267), as well as the non-nucleoside polymerase inhibitor dasabuvir (ABT-333), with or without ribavirin.
In this open-label trial, 31 people were assigned to take 3D with ribavirin for 12 weeks and 32 others were given the same regimen for 24 weeks.
Twenty-nine (93.5 percent) of those taking 12 weeks of treatment achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). The 24-week cohort is further behind in the process, so there is only data available about SVR4; thirty-one (96.9 percent) in this group have made it to that milestone, which is a good indication that they will achieve a cure once another eight weeks passes.
Two participants experienced virologic failure, both of whom were prior null responders to treatment who had genotype 1a of hep C and compensated cirrhosis. One participant, who was in the 12-week arm, withdrew consent from the trial but had an undetectable viral load at the last study visit, which was at week 10 of treatment.
There were no serious adverse events in either cohort. The most commonly reported side effects were fatigue, insomnia, nausea, headache, upper respiratory infection and itching.