Table 1.
Treatment-Related Parameters for Sofosbuvir/Ledipasvir-Based Therapies and the Old Standard of Care for a Cost-Effectiveness Analysis
| HCV Geno type | HCV Treatment | Regimen and Duration (weeks) | SVR Rate Non-cirrhosis | SVR Rate-cirrhosis | Discontinuation Rate | Probability of Anemia | Duration of Anemia (6weeks) |
|---|---|---|---|---|---|---|---|
| Treatment-Naive Interferon-Tolerant Patients | |||||||
|
| |||||||
| G1 | SOF/LDV-based (26, 27) | LDV+SOF 8a | 97% | -- | 1% | 1% | 1 |
| LDV+SOF 12a | 96% | 97% | 1% | 1% | 2 | ||
|
| |||||||
| oSOC (32, 33) | BOC+PEG+RBV | 67% | 52% | 28–42% | 49% | 15–21 | |
| TEL+PEG+RBV | 75% | 62% | 21% | 37% | 12 | ||
|
| |||||||
| G2 | SOF-based (9) | SOF+RBV 12 | 97% | 83% | 1% | 8% | 4 |
|
| |||||||
| oSOC (9) | PEG+RBV 24 | 81% | 62% | 11% | 11% | 8 | |
|
| |||||||
| G3 | SOF-based (28) | SOF+RBV 24 | 94% | 92% | 2% | 11% | 7 |
|
| |||||||
| oSOC (37) | PEG + RBV 24 | 70% | 49% | 7% | 16% | 8 | |
|
| |||||||
| G4 | SOF-based (9) | SOF+PEG+RBV 12 | 99% | 85% | 2% | 21% | 4 |
|
| |||||||
| oSOC (36) | PEG+RBV 48 | 58% | 32% | 7% | 16% | 18 | |
|
| |||||||
| Treatment-Naive Interferon-Intolerant Patientsb | |||||||
|
| |||||||
| G1 | SOF/LDV-based (26, 27) | LDV+SOF 8a | 97% | -- | 1% | 1% | 1 |
| LDV+SOF 12a | 96% | 97% | 1% | 1% | 2 | ||
|
| |||||||
| G2 | SOF-based (29) | SOF+RBV 12 | 92% | 94% | 2% | 13% | 4 |
|
|
|||||||
| G3 | SOF-based (28) | SOF+RBV 24 | 93% | 92% | 2% | 11% | 7 |
|
|
|||||||
| G4 | SOF-based (30) | SOF+RBV 24 | 93% | 93% | 1% | 11% | 7 |
|
|
|||||||
| G1–4 | oSOC | No treatment | 0% | 0% | -- | -- | -- |
|
| |||||||
| Treatment-Experienced Patients | |||||||
|
| |||||||
| G1 | SOF/LDV-based (10) | LDV+SOF 12 | 95% | -- | 0% | 0% | -- |
| LDV+SOF 24 | -- | 99% | 0% | 1% | 4 | ||
|
| |||||||
| oSOC (38–40) | BOC+PEG+RBV | 58% | 52% | 27–33% | 41–47% | 16–19 | |
| TEL+PEG+RBV | 70% | 58% | 23–36% | 30% | 12 | ||
|
| |||||||
| G2 | SOF-based (29) | SOF+RBV 12 | 96% | 60% | 1% | 11% | 4 |
|
| |||||||
| oSOC (34) | PEG+RBV 24 | 65% | 51% | 7% | 16% | 8 | |
|
| |||||||
| G3 | SOF-based (28) | SOF+RBV 24 | 85% | 60% | 2% | 11% | 7 |
|
| |||||||
| oSOC (34) | PEG + RBV 24 | 60% | 47% | 7% | 16% | 8 | |
|
| |||||||
| G4 | SOF-basedc | SOF+PEG+RBV 12 | 69% | 69% | 10% | 21% | 4 |
|
| |||||||
| oSOC (34) | PEG+RBV 48 | 31% | 24% | 40% | 16% | 14 | |
|
| |||||||
Abbreviations: AASLD, American Association for the Study of Liver Diseases; IDSA, Infectious Diseases Society of America; G1–4, genotype 1–4; SOF, sofosbuvir; PEG, peginterferon; RBV, ribavirin; oSOC, old standard of care; BOC, boceprevir; TEL, telaprevir; LDV, ledipasvir. SVR = sustained virologic response
In non-cirrhotic treatment-naïve patients, the duration of LDV+SOF depends on patient’s baseline HCV RNA. Those with HCV RNA less than 6 million IL/mL are considered for 8 weeks of treatment, and 12 weeks otherwise. Among this patient group, 57% of patients were eligible for 8 weeks of treatment.
We defined treatment ineligibility due to interferon-intolerance as one or more of the following conditions: bipolar disorder, anemia (Hgb < 10 g/d), pregnancy and neutropenia (neutrophils <750 cells/mm3; 1.2%)
No clinical study evaluated the combination of sofosbuvir with peginterferon and ribavirin in genotype 4 patients. Therefore, we derived SVR rates of this combination using data from another study that used sofosbuvir and ribavirin for 24 weeks in genotype 4 patients.(30) We assumed that the addition of peginterferon would increase the SVR rates by another 10%, i.e. from 59% to 69%.