a. eva luable subjects are defined as those who have reached the specified time point at the time of the interim analysis.

b. pTVR: post-transplant virologic response (HCV RNA <LLOQ at 12 weeks post-procedure).

In patients that discontinued therapy at 24 weeks, according to protocol, the relapse rate was 11/15.

Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies

The following tables (Table 18 to Table 21) present data from Phase 2 and Phase 3 studies relevant to the dosing to help clinicians determine the best regimen for individual patients.

Table 18: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection

Patient population

(Study number/name)
 Regimen/Duration
 Subgroup
 SVR12 rate % (n/N)
 
Treatment-naïvea

(NEUTRINO)
 SOF+PEG+RBV 12 weeks
 Overall
 90% (262/292)
 
Genotype 1a
 92% (206/225)
 
Genotype 1b
 83% (55/66)
 
No cirrhosis
 93% (253/273)
 
Cirrhosis
 80% (43/54)
 
Treatment-naïve and co-infected with HIV

(PHOTON-1)
 SOF+RBV 24 weeks
 Overall
 76% (87/114)
 
Genotype 1a
 82% (74/90)
 
Genotype 1b
 54% (13/24)
 
No cirrhosis
 77% (84/109)
 
Cirrhosis
 60% (3/5)
 
Treatment-naïve

(QUANTUMb and 11-1-0258b)
 SOF+RBV 24 weeks
 Overallc
 65% (104/159)
 
Genotype 1ac
 69% (84/121)
 
Genotype 1bc
 53% (20/38)
 
No cirrhosisc
 68% (100/148)
 
Cirrhosisc
 36% (4/11)
 
n = number of subjects with SVR12 response; N = total number of subjects per group.

a. For previously treated patients with genotype 1 HCV infection, no data exists with the combination of sofosbuvir, peginterferon alfa and ribavirin. Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (prior null response to peginterferon alfa and ribavirin therapy, advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).

b. These are exploratory or Phase 2 studies. The outcomes should be interpreted with caution, as subject numbers are small and SVR rates may be impacted by the selection of patients.

c. Summary data from both studies.

Table 19: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection

Patient population

(Study number/name)
 Regimen/Duration
 Subgroup
 SVR12 rate % (n/N)
 
Treatment-naïve

(FISSION)
 SOF+RBV 12 weeks
 Overall
 95% (69/73)
 
No cirrhosis
 97% (59/61)
 
Cirrhosis
 83% (10/12)
 
Interferon intolerant, ineligible or unwilling

(