studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 757A
1111
Sofosbuvir and Ledipasvir for the Treatment of HCV
GT-1, Cirrhotics and Non-Cirrhotics: Real-World Effectiveness
Kirat Gill, Garrett Fante, Shirin Nafisi, Ann Moore, Ashley Hepner,
Justin A. Reynolds, Karen Arendt, Yvette Cummings, Robert Gish,
Richard A. Manch, Anita Kohli; Hepatology, St. Joseph’s Hospital
and Medical Center, Creighton University School of Medicine,
Phoenix, AZ
The interferon and ribavirin (RBV) free combination of sofosbuvir
(SOF) and ledipasvir (LDV), a hepatitis C nucleotide NS5B
and N5A inhibitor respectively, have demonstrated high rates
of sustained virologic response (SVR) in clinical trials of both
treatment naïve and experienced patients, as well as cirrhotic
and non-cirrhotic patients, with chronic hepatitis C (CHC). Real
world non-clinical trial data for patients with CHC treated with
SOF/LDV ± RBV is lacking. AIM: To evaluate the effectiveness
of SOF/LDV for treatment of HCV genotype 1 (GT1) in a realworld
patient population. METHODS: We performed a retrospective
analysis of patients with CHC GT1 treated between
October 2014-June 2015 (n=197) at a community based clinic
within an academic medical center in Phoenix, AZ or by ECHO
telemedicine to rural clinic sites. Demographics, CHC treatment
regimens, liver fibrosis, virologic data and psychiatric
history were collected throughout treatment and post-treatment
from patient charts. RESULTS: Since October 2014, 197 GT1
patients started treatment for CHC and are included in the
current analysis. 81.7% of patients were Caucasian, 11.2%
of patients were Hispanic and 1.5% Native American. 65% of
patients were men, the mean age was 59 yrs. (range: 18-82
yrs.) and mean HCV viral load 2,359,054 IU/mL (range:
1,107-18,285,438 IU/mL). 75% of patients were GT 1a and
24% were GT1b. 53.3% of patients had cirrhosis by imaging,
Fibrosure or liver biopsy. 29.4% of patients had a concomitant
psychiatric illness. 45.2% (n=89) of patients were previously
treated. 50% (n=100) of patients were treated with the SOF/
LDV for 12 weeks, 31.0% (n=61) with SOF/LDV for 24 weeks,
18.3% (n=36) with SOF/LDV for 8 weeks and 1.0% (n=2)
treated with SOF/LDV/RBV for 12 weeks. Overall, 87.5% of
patients treated with SOF/LDV for 12 weeks and who have
reached the SVR12 timepoint (n= 16) have achieved SVR12,
and 12.5% have relapsed (pending for 84 patients). SVR12
data is pending for 60 patients treated with 24 weeks with
SOF/LDV with one patient having relapsed. 100% of patients
treated with SOF/LDV for 8 weeks and who have reached
the SVR12 timepoint (n=10) have achieved SVR12 (pending
for 26 patients). SVR12 is pending in the two patients treated
with SOF/LDV/RBV. Full results of SVR 12 will be presented
and stratified by cirrhosis and viral genotype. CONCLUSION:
Treatment for hepatitis C GT1 using SOF/LDV based therapies
has been well tolerated with high rates of SVR to date. SVR
results in this real world population, enriched for patients with
advanced liver disease, and treated by hepatologists as well as
primary care providers, will be presented.
Disclosures:
Robert Gish - Advisory Committees or Review Panels: Gilead, AbbVie, Arrowhead;
Consulting: Eiger, Isis, Genentech; Speaking and Teaching: Gilead, Abb-
Vie; Stock Shareholder: Arrowhead
Richard A. Manch - Speaking and Teaching: Gilead, AbbVie, Bayer, Salix, BMS
The following authors have nothing to disclose: Kirat Gill, Garrett Fante, Shirin
Nafisi, Ann Moore, Ashley Hepner, Justin A. Reynolds, Karen Arendt, Yvette
Cummings, Anita Kohli
1112
Telaprevir in the Treatment of Acute HCV infection in
HIV-infected Men: Final Results
Daniel S. Fierer 2 , Douglas Dieterich 1 , Michael P. Mullen 2 , Andrea
D. Branch 1 , Alison J. Uriel 1,6 , Damaris C. Carriero 1,7 , Wouter van
Seggelen 2,3 , Rosanne M. Hijdra 2,3 , David Cassagnol 2,5 , Tristan
Morey 2,4 ; 1 Liver Diseases, Icahn School of Medicine at Mount
Sinai, New York, NY; 2 Infectious Diseases, Icahn School of Medicine
at Mount Sinai, New York, NY; 3 Amsterdam Medical Center,
Amsterdam, Netherlands; 4 James Cook University, Cairns, QLD,
Australia; 5 Weill Cornell Medical College, New York, NY; 6 North
Manchester General Hospital, Manchester, United Kingdom;
7 Columbia University School of Medicine, New York, NY
Background Treatment of HCV with pegylated interferon (pIFN)
and ribavirin (RBV) is significantly more effective in the acute
phase than in the chronic phase. Incorporating telaprevir (TVR)
into the treatment of chronic HCV both improves the efficacy
and shortens the duration of treatment, and our preliminary evidence
suggested it can do the same in acute HCV. We present
here the final results of our study of TVR + pIFN + RBV for acute
HCV in HIV-infected men. Methods This is an IRB-approved,
open-label, consecutive enrollment study of TVR (TID or BID)
+ pIFN-α 180 μg/week + weight-based RBV for 12 weeks in
HIV-infected men with acute genotype 1 HCV infection. Stopping
rule was HCV VL > 1,000 IU/mL at week 4. Allowed
ARVs were tenofovir+emtricitabine, efavirenz (with TVR dose
adjustment), rilpivirine, atazanavir/ritonavir, and raltegravir.
HCV VL was measured by transcription-mediated amplification
(TMA, lower limit of detection 5 IU/mL). The comparator
group was HIV-infected men with acute genotype 1 HCV either
treated during the 3 years prior to the FDA approval of TVR or
those ineligible for TVR. Results Thirty-six men in the TVR group
and 50 men in the comparator group completed treatment and
SVR 12 assessment. The two treatment groups did not differ in
proportion of genotype 1a (84% vs 90%, respectively), IL28B
CC (45% vs 42%, respectively), age, or race/ethnicity. Thirty-two
(89%) achieved SVR 12 in the TVR group compared to
32 (64%) in the comparator group (p = 0.01). Most (88%) in
the TVR group received ≤12 weeks total treatment, while all
in the comparator group received ≥24 weeks total treatment.
TVR treatment resulted in faster VL kinetics among those who
achieved SVR, with median time to HCV VL 75%. With the availability now of interferon-free regimens,
though, efforts should move toward developing these less toxic
regimens. Clinicians who do not have access to interferon-free
regimens, however, should be alert to detect acute HCV infection
in HIV-infected men to take advantage of this highly-effective
TVR-based therapy.
Disclosures:
Daniel S. Fierer - Stock Shareholder: Gilead
Douglas Dieterich - Advisory Committees or Review Panels: Gilead, BMS, Abbvie,
Janssen, Merck, Achillion
Michael P. Mullen - Advisory Committees or Review Panels: GILEAD; Speaking
and Teaching: GILEAD
Andrea D. Branch - Grant/Research Support: Gilead, Janssen
Damaris C. Carriero - Advisory Committees or Review Panels: Abbvie, BMS;
Consulting: Gilead; Speaking and Teaching: Gilead
The following authors have nothing to disclose: Alison J. Uriel, Wouter van Seggelen,
Rosanne M. Hijdra, David Cassagnol, Tristan Morey