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Sofosbuvir/ledipasvir regimens can cost less per cure than older hepatitis C treatments
Keith Alcorn, 2016-06-15 10:00:00
The cost of treating chronic hepatitis C with sofosbuvir/ledipasvir (Harvoni) is lower than the cost of prior
interferon-based therapy with first-generation direct-acting antivirals (DAAs),
in part because the newer drugs are well-tolerated and require less management
of side effects, according to a Kaiser Permanente study presented at the 2016 Digestive
Disease Week meeting last month in San Diego.
The advent of next-generation DAAs that can be used in interferon-free
regimens has revolutionised treatment for chronic hepatitis C, making it
shorter, better tolerated and much more effective. But the high cost of the new
drugs has hampered widespread access, as some public payers and insurance
companies have restricted treatment to sicker patients. Yet despite its high
cost several studies have found that treatment is cost-effective, and it may
compare favourably with older options.
Nyberg of Kaiser Permanente in San Diego and
colleagues used detailed cost mapping to determine the cost per cure for
genotype 1 chronic hepatitis C patients treated with sofosbuvir/ledipasvir,
with or without ribavirin.
The usual recommended
sofosbuvir/ledipasvir treatment duration is 12 weeks, but some previously
untreated people without liver cirrhosis are eligible for 8 weeks. Prior
non-responders and cirrhotics may benefit from adding ribavirin. The
researchers considered sustained virological response rates at 4 weeks
post-treatment (SVR4) -- a good predictor of sustained response at 12 week
post-treatment (SVR12), which is considered a cure.
prior standard of care - pegylated interferon, ribavirin and the
first-generation HCV protease inhibitors telaprevir
(Incivo) or boceprevir (Victrelis) -- could cost around US$189,000
per SVR, the researchers noted as background. This was due in part to expenses
associated with managing side effects, for example erythropoietin or blood
transfusions for anaemia. In addition, interferon-based therapy was not as
effective as the newer DAAs so treatment costs were sometimes wasted without
achieving a cure.
Dr Nyberg's team conducted a
retrospective cohort study of 1262 adults treated for hepatitis C at Kaiser
Permanente Southern California between November 2014 and July 2015. Cost
estimates were based on current Medicare rates for services, lab tests and
medical equipment and supplies. Prescription dispensing records were used to
determine wholesale acquisition costs for the drugs.
They found that the overall
average cost per SVR was $75,502 for non-cirrhotic hepatitis C patients and
$100,518 for people with cirrhosis, but this varied by specific regimen.
For the 288 non-cirrhotic people
treated with sofosbuvir/ledipasvir alone for 8 weeks, the SVR rate was 97.0%
and the average cost per SVR was $55,674. The small number of cirrhotics (n=37)
treated with this short regimen had an SVR rate of 92.5% and about the same
average cost, $55,226. The five cirrhotic patients treated with
sofosbuvir/ledipasvir plus ribavirin for 8 weeks had an SVR rate of 83.3% and a
cost per SVR of $80,518; no non-cirrhotics received this regimen.
For the 316 non-cirrhotic patients
treated with sofosbuvir/ledipasvir for 12 weeks, the SVR rate was 96.9% and the
average cost per SVR was $86,663. For 182 cirrhotics on the same regimen the
SVR rate was 97.3% and the average cost was $92,873. For cirrhotic patients
treated for 12 weeks with ribavirin, the SVR rate was 98.8% and the average
cost was highest, at $94,531. Only a small number of non-cirrhotics (n=48)
received this regimen, with an SVR rate of 98.0% and an average cost of
"Because of the better
tolerability of the new agents and the high SVR [rate], cost per SVR using
sofosbuvir/ledipasvir with and without ribavirin for the treatment of genotype
1 chronic hepatitis C in both cirrhotics and non-cirrhotics is lower than that
previously reported using interferon-based treatment with and without first
generation direct acting antiviral agents," the researchers concluded.