1028. Early Treatment Results for Interferon-free Hepatitis Treatment Regimens
Session: Poster Abstract Session: Hepatitis Viruses
Friday, October 9, 2015
Room: Poster Hall
Background:   The VA Healthcare System is one of the largest Hepatitis C care providers in the nation.  The goal of treatment is to achieve a sustained virologic response (SVR).  Previous SVR rates at the NJ VA facility with Pegylated Interferon-based therapy was 30% in mono-infected and<10% in co-infected population.   Use of first degree HCV protease inhibitor Boceprevir, increased SVR to 50%, however dropout rate was >35% due to intolerance.  With the newest DAAs now available with relatively few side effects, we examined our early data on tolerance and success.

Methods: Records of treatment and patient characteristics from June 2014 to May 2015  were examined via chart review.   Parameters included  indirect markers of fibrosis (HCV FibroSure test) HCV genotype,  HIV status, treatment naïve/experienced. Regimens used included Sofosbuvir/Ribavirin [1], Sofosbuvir/Simeprevir/Ribavirin[2], Harvoni[3], and Harvoni /Ribavirin [4].  Pt’s started on Viekira and Viekira + Ribavirin were not included for 12 week SVR data is still pending.  

Results:   132  patients have been treated with the above mentioned regimens.   Only one patient discontinued treatment after 4 weeks due to side effects of treatment.  Forty two percent (N=55) of patients have completed therapy.  SVR data is available on 21 patients, with the majority being treatment naive, mono-infected,  GT 1(a/b) and with cirrhosis (F4 Fibrosure).  90% (N=19)  have achieved a non detectable HCV viral load 12 weeks post treatment.  Of The 2 patients who failed, one tested PI resistant with the Q80K mutation and should have been on 3 drugs (Sof/Sim/Riba) instead of 2 (Sof/Riba). The other patient had undetectable HCV VL during treatment, however 12 week SVR was positive. HCV resistance test is pending.   Table 1 depicts patient demographics for the patients with SVR data (N=21).

Regimen

SVR12, %

Genotype

 

HIV status

 

Cirrhosis

[1]Sof/Rib  N=12

10, 83% 

1/1a

11

yes

3

12

[2]Sof/Sim/Rib N=6 

6, 100%

1b

2

no

18

[3]Harvoni N=2

2, 100%

2

7

Treatment Naive 

 

Non-cirrhosis

[4]Harvoni/Rib
N=1

1, 100%

 4

1

yes

16

 9

 

 

 

no

5

Conclusion:  Our experience with 2nd generation DAAs in regimens [1]-[4] have thus found great tolerability and very low dropout rates.  Efficacy of regimens [2]-[4] have been 100% SVR.  Efficacy of regimen [1] is 83%.  This experience is remarkably better than the 1st generation DAAs or the interferon-based regimens.

Sandra Kaminski, MS, PA-C1, Kendra Vermeulen, Pharm.D., AAHIVP2, Sharon Morgan, APN3, Nancy Celander, RPH2 and Robert H K Eng, MD1, (1)Infectious Disease, VA New Jersey Healthcare System, East Orange, NJ, (2)Pharmacy, VA New Jersey Healthcare System, East Orange, NJ, (3)Gastroenterology, VA New Jersey Healthcare System, East Orange, NJ

Disclosures:

S. Kaminski, None

K. Vermeulen, None

S. Morgan, None

N. Celander, None

R. H. K. Eng, None

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