Sofosbuvir
Treatment of chronic hepatitis C (CHC) in treatment-naïve and treatment-experienced patients with genotypes 1-6, administered in combination with peginterferon alfa and ribavirin or ribavirin alone, depending on genotype and treatment experience.
Decisions on record
- Meeting Jul 2017 Not recommended Chronic hepatitis C virus (HCV) infection
- Meeting Nov 2016 Recommended Chronic hepatitis C virus (HCV) infection
- Meeting Mar 2015 Recommended Hepatitis C virus (HCV) infection
Access path
- Jul 2014Not recommended
vs Peginterferon alfa and ribavirin (PEG+RBV) for…
- ↻ resubmittedMar 2015Recommended · restricted
Listing: Authority Required → Restricted
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the Authority Required listing of sofosbuvir for the treatment of Genotype 2 CHC (when in combination with ribavirin, 12 weeks) and Genotype 3 CHC (when in combination with ribavirin, 24 weeks) on the basis of cost- effectiveness of the treatment over no treatment.PSD · Mar 2015
7.2 The PBAC reiterated that the Committee recognised that new treatments of HCV resulted in high rates of sustained virological response, where the HCV virus could not be detected in the blood of patients 12 weeks after treatment commenced.PSD · Mar 2015
6.12 The re-submission presented a modelled economic evaluation based on an unadjusted comparison of results from single arms of different studies that was similar to the previous submission. The evaluation was structured as a Markov state- transition model with nine health states, which described the progression of disease over the lifetime. The model captured both on-treatment and off-treatment phases. 6.13 The re-submission updated the model:PSD · Mar 2015
• To allow for re-infection (annual rate of 0.5% has been assumed);PSD · Mar 2015
• Superior comparative effectiveness to peginterferon-containing active treatment and no treatment, and • Inferior comparative safety to no treatment, andPSD · Mar 2015
• Superior comparative safety to peginterferon-containing active treatments.PSD · Mar 2015
6.2 The PBAC noted and welcomed the input from individuals (231), health care professionals (14) and organisations (18) via the Consumer Comments facility on the PBS website. The PBAC noted the correspondence from the Gastroenterological Society of Australia (GESA) on the use of DAAs in the treatment of patients with liver cirrhosis and severe portal hypertension, decompensated liver disease, or patients post liver transplant.PSD · Mar 2015
6.3 Representatives of the PBAC met with Hepatitis Australia, Hepatitis NSW, the Australian Injecting and the Illicit Drug User’s League prior to the PBAC meeting, and reported the following key points to the PBAC in relation to the agenda items for the treatment of Hepatitis C: :PSD · Mar 2015
Cost-effectiveness
Pricing information is redacted (indicated by '''''''''''''''''''''''' placeholders in the text). No ICER is explicitly stated in this PSD.
Decision context
PopulationAdults aged 18 years or older with compensated liver disease and chronic hepatitis C (genotypes 1-6), either treatment-naïve or treatment-experienced, excluding those who are breastfeeding or have previously received oral direct-acting antiviral agents (except where intolerance requiring permanent withdrawal has been documented).
Risk sharingA special pricing arrangement (rebate) was proposed to cap the cost of the sofosbuvir component of a 24-week course of treatment for genotype 3 patients.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended · restricted | — | — | RCT · SVR12 |
| Jul 2014 | Not recommended | Peginterferon alfa and ribavirin (PEG+RBV) for treatment-naïve patients suitable for interferon; no treatment for other | — | RCT · SVR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NEUTRINO | Ph 3 | 328 | Percentage of Participants Achieving Sustained Virologic Response (SVR)12 | completed |
| FISSION | Ph 3 | 527 | Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All S… | completed |
| POSITRON | Ph 3 | 278 | Percentage of Participants Achieving SVR12 | completed |
| FUSION | Ph 3 | 202 | Percentage of Participants Achieving SVR12 | completed |
| ADVANCE | Ph 2 | 129 | Comparison of Sustained Viral Response at 12 Weeks Post Treatment (SVR12) in the Three Tre… | completed |
Consumer voice
Consumer input highlighted the significant burden of hepatitis C disease and high demand for highly effective direct-acting antiviral treatments. Key concerns included lack of access to treatment, adverse effects of current therapies, preference for shorter treatment durations, and need for broad access not limited by disease severity.
The large number of comments and discussion highlighted the benefit of the availability of a highly effective treatment that should be made available for all infected individuals, the improved quality of life as well as the side effects avoided associated with the current treatments. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to compensated liver disease and documented chronic HCV infection; TGA label does not specify these clinical criteria.