The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 4). The adverse reactions are listed below by body system organ class and frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).

Table 4: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin

Frequency
 SOFa + RBVb
 SOF + PEGc + RBV
 
Infections and infestations:
 
Common
 nasopharyngitis
  
Blood and lymphatic system disorders:
 
Very common
 haemoglobin decreased
 anaemia, neutropenia, lymphocyte count decreased, platelet count decreased
 
Common
 anaemia
  
Metabolism and nutrition disorders:
 
Very common
   decreased appetite
 
Common
   weight decreased
 
Psychiatric disorders:
 
Very common
 insomnia
 insomnia
 
Common
 depression
 depression, anxiety, agitation
 
Nervous system disorders:
 
Very common
 headache
 dizziness, headache
 
Common
 disturbance in attention
 migraine, memory impairment, disturbance in attention
 
Eye disorders:
 
Common
   vision blurred
 
Respiratory, thoracic and mediastinal disorders:
 
Very common
   dyspnoea, cough
 
Common
 dyspnoea, dyspnoea exertional, cough
 dyspnoea exertional
 
Gastrointestinal disorders:
 
Very common
 nausea
 diarrhoea, nausea, vomiting
 
Common
 abdominal discomfort, constipation, dyspepsia
 constipation, dry mouth, gastroesophageal reflux
 
Hepatobiliary disorders:
 
Very common
 blood bilirubin increased
 blood bilirubin increased
 
Skin and subcutaneous tissue disorders:
 
Very common
   rash, pruritus
 
Common
 alopecia, dry skin, pruritus
 alopecia, dry skin
 
Musculoskeletal and connective tissue disorders:
 
Very common
   arthralgia, myalgia
 
Common
 arthralgia, back pain, muscle spasms, myalgia
 back pain, muscle spasms
 
General disorders and administration site conditions:
 
Very common
 fatigue, irritability
 chills, fatigue, influenza-like illness, irritability, pain, pyrexia
 
Common
 pyrexia, asthenia
 chest pain, asthenia

a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.

Other special population(s)

HIV/HCV co-infection

The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected subjects was similar to that observed in mono-infected HCV subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).

Patients awaiting liver transplantation

The safety profi