Ravida Adverse Reactions

Summary of the safety profile: The summary of the safety profile of Ravida is based on data from 301 adult subjects with chronic HCV infection (with no or compensated cirrhosis), who received Ravida in combination with sofosbuvir once daily in the STORM-C-1 study. Among them, 90 were HIV co-infected.
Adverse reactions described as follows relate to treatment with the combination of Ravida plus sofosbuvir. No adverse reactions specific to Ravida alone have been identified.
Ravida in combination with sofosbuvir: The majority of adverse reactions identified with Ravida co-administered with sofosbuvir were of mild or moderate intensity, regardless of the presence or absence of cirrhosis, HIV co-infection, prior HCV treatment or HCV genotype. There were few severe adverse reactions and none that were life-threatening. Two subjects discontinued the Ravida plus sofosbuvir regimen due to adverse events assessed as being related to study treatment.
The most frequent adverse reactions identified in patients receiving Ravida and sofosbuvir were pyrexia (11.6%), headache (6.6%), dizziness (5.6%), lethargy (5.3%), dyspepsia (5.0%) and nausea (5.0%).
Tabulated list of adverse reactions: Based on STORM-C-1 data in 301 subjects, adverse reactions identified with Ravida administered in combination with sofosbuvir are listed in Table 9 by MedDRA System Organ Class, with Preferred Term (PT).
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) and very rare (<1/10,000). (See Table 9.)

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Description of selected adverse reactions: HCV/HIV co-infection: The overall safety profile of Ravida administered in combination with sofosbuvir in HCV/HIV co-infected subjects was comparable to that observed in HCV mono-infected subjects.
General recommendation on combination therapy: Refer to the monograph of other medicinal products with which Ravida will be combined for descriptions of selected adverse reactions.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the safety profile and benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.