, Nov. 11, 2014
-- AbbVie (NYSE: ABBV) today announced results from studies in chronic
hepatitis C patients with human immunodeficiency virus type 1 (HIV-1)
co-infection (TURQUOISE-I) and liver transplant recipients (CORAL-I) at
The Liver Meeting®2014.
New, detailed results from part one of the Phase 2 portion of
AbbVie's Phase 2/3 open-label study, TURQUOISE-I, showed patients
co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and HIV-1
receiving AbbVie's investigational treatment and ribavirin (RBV) for 12
weeks or 24 weeks achieved sustained virologic response rates 12 weeks
post-treatment (SVR12) of 93.5 percent (n=29/31) and 90.6 percent (n=29/32), respectively. These data were presented today, November 11, as a "Poster of Distinction."
"Patients living with both chronic HCV and HIV have been historically considered more difficult to treat," said Barry Bernstein,
M.D., vice president, infectious disease development, AbbVie.
"TURQUOISE-I is one of the few dedicated studies looking specifically at
this population, who are seen in everyday clinical practice. These data
will help us gain a better understanding of how our investigational
treatment works in this subpopulation of genotype 1 patients."
Additionally, results from the first cohort of AbbVie's ongoing
open-label Phase 2 study, CORAL-I, were presented today during an oral
session and published online in The New England Journal of Medicine.
Results showed that non-cirrhotic liver transplant patients with
recurrent GT1 HCV and new to treatment after transplantation achieved a
SVR12 rate of 97.1 percent (n=33/34) and a sustained virologic response rate 24 weeks post-treatment (SVR24) of 97.1 percent (n=33/34) after 24 weeks of treatment.
"Recurrence of HCV infection in the new graft post-liver
transplantation is universal in those that have the virus prior to
transplantation, and can be associated with an aggressive disease
course," explained Dr. Paul Kwo, medical director of liver transplantation and professor of medicine, Indiana University School of Medicine.
"The high SVR rates seen in CORAL-I are promising and offer valuable
information as we continue to assess this regimen within this specific
TURQUOISE-I is an ongoing Phase 2/3, multi-center, randomized,
open-label study evaluating the efficacy and safety of AbbVie's
all-oral, interferon-free investigational treatment combining three
direct-acting antivirals (ombitasvir/ABT-450/ritonavir and dasabuvir)
with RBV (weight based dosing of 1000 mg or 1200 mg per day divided
twice daily) for 12 or 24 weeks in adult patients with chronic GT1 HCV
infection with or without compensated liver cirrhosis who are also
infected with HIV-1. Study patients were either new to therapy
(treatment naïve) or had failed previous treatment with pegylated
interferon and RBV (treatment-experienced), had a stable immune status
(CD4+ counts of ≥200 cells/mm3 or
CD4+ % ≥14%) and had HIV-1 ribonucleic acid levels suppressed on a
stable atazanavir- or raltegravir-based antiretroviral HIV therapy.
No patients discontinued treatment due to adverse events in either
the 12-week or 24-week arm. In the 12-week arm, no virologic
breakthroughs were observed while on treatment. One patient (3.3
percent) experienced post-treatment relapse after 12 weeks of treatment.
In the 24-week treatment arm, one virologic breakthrough was observed
(3.1 percent). Two patients in the 24-week treatment group were believed
to have been re-infected post-treatment by a different strain of HCV
than the original infection. The most commonly reported adverse events
(greater than 15 percent in both treatment arms combined) were fatigue
(47.6 percent), insomnia (19 percent), nausea (17.5 percent), and
headache (15.9 percent). Elevations in total bilirubin were the most
common laboratory abnormality (68.3 percent), were mainly composed of
indirect bilirubin, and were not associated with aminotransferase
elevations. Reductions in RBV dose because of anemia or reduced
hemoglobin occurred in 9.5 percent of patients (n=6/63); all six
patients achieved SVR12.
CORAL-I is an ongoing Phase 2, multi-center, two-cohort, open-label
study evaluating the efficacy and safety of AbbVie's all-oral,
interferon-free investigational treatment combining three direct-acting
antivirals (ombitasvir/ABT-450/ritonavir and dasabuvir) with RBV (RBV
dosing left up to the discretion of the investigator) for 24 weeks in
adult non-cirrhotic (screening biopsy Metavir score ≤F2) liver
transplant recipients with recurrent chronic GT1 HCV infection. Patients
in the study initiated therapy at least 12 months after receiving a
liver transplant, had not received other HCV therapy since their liver
transplant, and were on a stable immunosuppressant regimen based on
either tacrolimus or cyclosporine, for which dose adjustments were
advised. Enrollment in the second cohort of the study is ongoing.
One patient (2.9 percent) discontinued the study due to adverse events but still achieved SVR12.
Two patients experienced serious adverse events. The most commonly
reported treatment-emergent adverse events (greater than 20 percent)
were fatigue (50 percent), headache (44.1 percent), cough (32.4
percent), anemia (29.4 percent), diarrhea (26.5 percent), insomnia
(26.5), asthenia (23.5 percent), nausea (23.5 percent), muscle spasms
(20.6 percent), and rash (20.6 percent). No patients experienced
virologic breakthrough while on treatment; however, one patient
experienced post-treatment relapse. Nine patients had a grade 2
reduction in hemoglobin, and one patient had a grade 3 reduction. Five
patients with hemoglobin decreases (anemia) received a medication to
boost their red blood cell production at the investigator's discretion.
No patients discontinued study drugs because of anemia, required a blood
transfusion, or experienced a rejection of their transplanted liver.
Read complete press release here
Labels: AASLD 2014, Abbvie 3D, Coinfection, CORAL-I, Liver Transplant, TURQUOISE-I