Table 15 presents the response rates by genotype and exposure to prior HCV treatment.

Table 15: Response rates in study PHOTON-1

  Genotype 2/3 treatment-naïve

SOF+RBV

12 weeks

(n = 68)
 Genotype 2/3 treatment-experienced

SOF+RBV

24 weeks

(n = 28)
 Genotype 1 treatment-naïve

SOF+RBV

24 weeks

(n = 114)
 
Overall SVR12
 75% (51/68)
 93% (26/28)
 76% (87/114)
 
Outcome for subjects without SVR12
      
On-treatment virologic failure
 1% (1/68)
 0/28
 1% (1/114)
 
Relapsea
 18% (12/67)
 7% (2/28)
 22% (25/113)
 
Otherb
 6% (4/68)
 0/28
 1% (1/114)
 
a. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.

b. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).

Table 16 presents the subgroup analysis by genotype for cirrhosis.

Table 16: SVR12 rates for selected subgroups by genotype in study PHOTON-1

  HCV genotype 2
 HCV genotype 3
 
SOF+RBV

12 weeks

TN (n = 26)
 SOF+RBV

24 weeks

TE (n = 15)
 SOF+RBV

12 weeks

TN (n = 42)
 SOF+RBV

24 weeks

TE (n = 13)
 
Overall
 88% (23/26)
 93% (14/15)
 67% (28/42)
 92% (12/13)
 
No cirrhosis
 88% (22/25)
 92% (12/13)
 67% (24/36)
 100% (8/8)
 
Cirrhosis
 100% (1/1)
 100% (2/2)
 67% (4/6)
 80% (4/5)

TN = treatment-naïve; TE = treatment-experienced.

Patients awaiting liver transplantation - Study 2025

Sofosbuvir was studied in HCV infected subjects prior to undergoing liver transplantation in an open-label clinical study eva luating the safety and efficacy of sofosbuvir and ribavirin administered pre-transplant to prevent post-transplant HCV reinfection. The primary endpoint of the study was post-transplant virologic response (pTVR, HCV RNA <LLOQ at 12 weeks post-transplant). HCV infected subjects, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first. An interim analysis was conducted on 61 subjects who received sofosbuvir and ribavirin; the majority of subjects had HCV genotype 1, 44 subjects were CPT class A and 17 subjects were CPT class B. Of these 61 subjects, 44 subjects underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA <LLOQ at the time of transplantation. The virologic response rates of the 41 subjects transplanted with HCV RNA <LLOQ is described in Table 17. Duration of viral suppression prior to transplantation was the most predictive factor for pTVR in those who were HCV RNA <LLOQ at the time of transplantation.

Table 17: Virologic response post-transplant in subjects with HCV RNA <LLOQ at the time of liver transplantation

  Week 12

p