sofosbuvir, velpatasvir and voxilaprevir
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Tratamiento de la infección crónica por VHC en adultos sin cirrosis o con cirrosis compensada, tanto sin tratamiento previo como previamente tratados con antivirales de acción directa, según genotipo y antecedentes.
Contraindicaciones
Absolutas
- Hipersensibilidad a sofosbuvir, velpatasvir, voxilaprevir o excipientes.
- Uso concomitante de inductores potentes de P-gp o CYP, como carbamazepina, fenobarbital, fenitoína, rifampicina, rifabutina o hipérico.
- Uso concomitante de rosuvastatina, dabigatrán o medicamentos con etinilestradiol.
Advertencias clínicas
- Evalúa VHB antes de iniciar por riesgo de reactivación. — CIMA/AEMPS, ficha técnica 1171223001
- Amiodarona puede causar bradicardia grave; usa solo sin alternativa y con monitorización. — CIMA/AEMPS, ficha técnica 1171223001
- No se recomienda en Child-Pugh B o C ni en personas con antecedente de descompensación; se han notificado descompensación y fallo hepático. — DailyMed, set_id 17ffc094-8ca7-45d2-80d8-fd043bc9a221
Interacciones medicamentosas
- SeveraAmiodarona
Mecanismo: Puede causar bradicardia o bloqueo cardiaco potencialmente mortal.
Recomendación: Usa solo si no hay alternativa y monitoriza intensivamente.
CIMA/AEMPS, ficha técnica 1171223001
- SeveraEstatinas y sustratos de transportadores
Mecanismo: Voxilaprevir aumenta la exposición de varios sustratos.
Recomendación: Revisa contraindicaciones y límites de dosis por estatina.
CIMA/AEMPS, ficha técnica 1171223001
Eventos adversos
Comunes (≥1%)
Cefalea, diarrea y náuseas
Raros pero graves
Reactivación del VHB, bradicardia grave y descompensación hepática
Embarazo y lactancia
Es preferible evitar durante el embarazo y no usar durante la lactancia.
Bibliografía reciente (PubMed)
The combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is recommended for the retreatment of patients with HCV infection in whom previous direct-acting antiviral (DAA) treatment failed. However, whether ribavirin further increases the therapeutic efficacy of SOF/VEL/VOX retreatment remains unclear. We aimed to test this hypothesis in a randomized-controlled trial. We randomly assigned 315 patients with DAA treatment failure from five Egyptian sites into two groups. Group A (n = 158) received SOF/VEL/VOX for 12 weeks, and group B (n = 157) received SOF/VEL/VOX + weight-based ribavirin for 12 weeks. Therapeutic efficacy was defined as SVR12 (sustained virologic response 12 weeks after treatment end). Safety and tolerability were evaluated by monitoring treatment-related adverse events (AEs) and laboratory abnormalities. Males comprised 53.9% of group A and 57.1% of group B (p = 0.58); mean ages were 51.8 and 47.3 years in group A and B, respectively. Seventeen patients in each group were lost to follow-up. SVR12 rates were 87.3% (138/158) by intention-to-treat analysis and 97.8% (138/141) by per-protocol analysis in group A; and 87.9% (138/157) and 98.5% (138/140), respectively, in group B (p = n.s. for intention-to-treat and per-protocol analyses). Both regimens were well-tolerated, with no deaths and only one serious AE (anemia) in group B, which required ribavirin discontinuation. Fifty-five patients in group A vs. 77 in group B experienced any AE (p = 0.002). This randomized-controlled trial showed equal, high efficacy of both regimens for the retreatment of previous DAA failures, although ribavirin was associated with more AEs. Therefore SOF/VEL/VOX monotherapy should be the preferred retreatment strategy. CLINCIALTRIALS. NCT04695769. HCV treatment guidelines recommend retreatment of direct-acting antiviral (DAA) treatment failures with the combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) for 12 weeks. However, whether riba