The sofosbuvir-velpatasvir (SOF/VEL) combination is a direct-acting antiviral therapy that is authorized and available in Mexico, making the performance of a real-world multicenter study that ...evaluates the sustained virologic response at 12 weeks post-treatment a relevant undertaking.
A retrospective review of the case records of 241 patients seen at 20 hospitals in Mexico was conducted to assess hepatitis C treatment with the SOF/VEL combination (n = 231) and the sofosbuvir/velpatasvir/ribavirin (SOF/VEL/RBV) combination (n = 10). The primary efficacy endpoint was the percentage of patients that achieved SVR at 12 weeks after the end of treatment.
Overall SVR was 98.8% (95% CI 97.35-100%). Only three patients did not achieve SVR, two of whom had cirrhosis and a history of previous treatment with peg-IFN. Of the subgroups analyzed, all the patients with HIV coinfection, three patients with genotype 3, and the patients treated with the SOF/VEL/RBV combination achieved SVR. The subgroups with the lower success rates were patients that were treatment-experienced (96.8%) and patients with F1 fibrosis (95.5%). The most frequent adverse events were fatigue, headache, and insomnia. No serious adverse events were reported.
Treatments with SOF/VEL and SOF/VEL/RBV were highly safe and effective, results coinciding with those of other international real-world studies.
The sofosbuvir-velpatasvir (SOF/VEL) combination is a direct-acting antiviral therapy that is authorized and available in Mexico, making the performance of a real-world multicenter study that ...evaluates the sustained virologic response at 12 weeks post-treatment a relevant undertaking.
A retrospective review of the case records of 241 patients seen at 20 hospitals in Mexico was conducted to assess hepatitis C treatment with the SOF/VEL combination (n = 231) and the sofosbuvir/velpatasvir/ribavirin (SOF/VEL/RBV) combination (n = 10). The primary efficacy endpoint was the percentage of patients that achieved SVR at 12 weeks after the end of treatment.
Overall SVR was 98.8% (95% CI 97.35–100%). Only three patients did not achieve SVR, two of whom had cirrhosis and a history of previous treatment with peg-IFN. Of the subgroups analyzed, all the patients with HIV coinfection, three patients with genotype 3, and the patients treated with the SOF/VEL/RBV combination achieved SVR. The subgroups with the lower success rates were patients that were treatment-experienced (96.8%) and patients with F1 fibrosis (95.5%). The most frequent adverse events were fatigue, headache, and insomnia. No serious adverse events were reported.
Treatments with SOF/VEL and SOF/VEL/RBV were highly safe and effective, results coinciding with those of other international real-world studies.
La combinación de sofosbuvir-velpatasvir (SOF/VEL) es una terapia antiviral de acción directa que está autorizada y disponible en México. Esto hace que la evaluación de la respuesta virológica sostenida (RVS) 12 semanas después del tratamiento, por medio de la realización de una revisión multicentro en el mundo real, sea una tarea relevante.
Se efectuó una revisión retrospectiva de los registros de 241 casos de pacientes atendidos en 20 hospitales en México para evaluar el tratamiento contra la hepatitis C con la combinación SOF/VEL (n = 231) y sofosbuvir/velpatasvir/ribavirin (SOF/VEL/RBV) (n = 10). El objetivo de eficacia primario fue el porcentaje de pacientes que lograron la RVS 12 semanas posterior a la finalización del tratamiento.
En general, la RVS fue de 98.8% (IC 95% 97.35 a 100%). Solo tres pacientes no lograron la RVS, de los cuales dos padecían cirrosis y una tenía historia previa de tratamiento con interferón pegilado (peg-IFN). De los subgrupos analizados, todos los casos con infección de virus de la inmunodeficiencia humana (VIH), tres con genotipo 3 y aquellos tratados con la combinación SOF/VEL/RBV, lograron RVS. Los subgrupos con tasas menores de éxito fueron los pacientes que tenían experiencia con tratamiento (96.8%) y pacientes con fibrosis F1 (95.5%). Los eventos adversos más frecuentes fueron fatiga, cefalea e insomnio. No se reportaron eventos adversos graves.
Los tratamientos con SOF/VEL y SOF/VEL/RBV fueron altamente seguros y efectivos y los resultados coinciden con los de otros estudios internacionales realizados en el mundo real.
Clinical trials demonstrated the efficacy and safety of direct antiviral agents (DAA) to treat hepatitis C virus infection (HCV) in patients with decompensated cirrhosis (DC); however, very few ...real-world studies have been reported in this group. Moreover, predictive factors for non-achieving sustained virological response (SVR) in DC are not entirely understood. Therefore, the aim was to verify the efficacy and safety of DAA and to identify risk factors for failure to achieve SVR in DC.
A real-world cohort study included HCV patients with DC Child-Pugh B/C or A but with a history of previous clinical decompensation events like variceal bleeding (VB), hepatic encephalopathy (HE), or ascites. All patients treated before transplant had MELD ≤ 20 and Child-Pugh ≤ 12 according to AASLD guidelines.
222 patients, 118 (53.2%) were women, mean age 57.2±11.5 year-old, 61 (27.5%) were treated with Sofosbuvir(SOF)/Ledipasvir, 152 (68.5%) with SOF/Velpatasvir, and 9 (4.1%) with SOF/Daclatasvir, 175 (78.8%) used also ribavirin, 209 (94.1%) achieved SVR, despite non-significant difference, Child-Pugh C patients had a suboptimal response (SVR < 95%): A 42/44 (95.5%), B 140/147 (95.2%), C 27/31 (87.0%), p=0.2. Related adverse events were fatigue 60 (27%), nausea 44 (19.8%), headache 43 (19.4%), non-severe peripheral edema 10 (4.5%), anasarca 4 (1.8%), jaundice 6 (2.7%), 3 hemolytic anemia (1.4%), 1 dermatosis (0.4%), congestive cardiac failure 2 (0.9%), need to suspend therapy due to liver-related adverse events 2 (0.9%) they also died. In those who achieved SVR, MELD improved (basal 12.4±3.3 vs. post-SVR 10.9±3.5; p<0.0001); but was worse in those without SVR (basal 16.2±3.9 vs. without-SVR 17.3±6.2; p=0.24). Times/year needing hospitalization for liver-related decompensation events were less frequent in those who achieved SVR (basal 1.7±1.3 vs. after SVR 0.4±0.7; p<0.0001) but remained without change in that without-SVR (basal 1.5±1.5 vs. after non-achieve SVR 2.2±1.9; p=0.04).
A few real-world studies have been conducted in DC with hepatitis C. However, in the Mexican population, our study is the first that demonstrated in a real-world setting, similar to clinical trials, that DAA based on SOF and free of protease inhibitors (PIs) are effective and safe to cure HCV in DC. When to treat HCV before or after liver transplantation can be challenging. Classically, MELD >20 and Child-Pugh C >12 are related to non-SVR; however, our study also shows that additional clinical factors have a negative impact on SVR: history of recurrent VB and episodic and persistent HE; therefore, these criteria should also be considered to decide to treat previous or after liver transplantation. In addition, acute decompensation and mortality events are very high in those who do not achieve SVR.
SOF based on regimens without PIs are effective and safe in VHC with DC. Additional to classic criteria (MELD >20, Child-Pugh > 12), recurrent VB and HE are predictors of failure to achieve SVR in VHC with DC.
The authors declare that there is no conflict of interest.
If direct antiviral agents (DAA) are related to the development of HCC is controversial; therefore, exploring risk factors are crucial. We aimed to determine factors related to the development of ...hepatocellular carcinoma (HCC) in patients with hepatitis c (HCV) and decompensated cirrhosis (DC) treated with DAA.
A multicenter real-world cohort study including patients with HCV + DC treated with sofosbuvir (SOF) based on regimens free of inhibitors of protease (IPs).
222 patients, 118 (53.2%) were women, mean age 57.2 ±11.5-year-old, 209 (94.1%) achieved sustained virological response (SVR). According to Child-Pugh 44(19.8%) were A with history of any clinical decompensation event, 147(66.2%) B, and 31 (14%) C. After DAA, 134 (60.4%) improve in MELD, 45 (20.3%) had no change, and 43 (19.4%) worse, this worse in MELD was related to non-SVR SVR 37/209 (17.7%) vs. non-SVR 6/13 (46.2%); OR=2.6, 95%CI:1.4-5.0, p=0.02. Nineteen (8.6%) developed HCC during the follow-up after therapy with DAA; however, when we compared basal laboratory values between those who developed HCC and those who did not only alfa-fetoprotein (AFP) levels were different (without HCC 14.3 mean 95%CI: 10.6-18.1 ng/mL vs. HCC 55.7 mean 95%CI: 28.4-83.0 ng/mL; p<0.006). Univariate and multivariate analyses are shown in Table 1.
Our study confirms that rather than DAA therapy, the most critical factors related to the development of HCC in DC patients with HCV treated with DAA, are non-achieve SVR and, most important basal AFP levels > 20ng/mL, it is essential to note that patients in this cohort had no any suspicious lesion in ultrasonography (USG) previous to start DAA therapy in their semestral screening as most of the guidelines recommend. AASLD, for example, recommends semestral HCC screening with USG with or without AFP, giving more weight to the imagen study. However, based on our results, we recommend always determining AFP levels as a compliment to USG.
In HCV patients with DC treated with DAA and with a negative basal screening USG for suspicious malignant lesions, basal AFP > 20ng/mL are the most critical factor related to the development of HCC and should be determined complementary to the USG study.
The authors declare that there is no conflict of interest.
La combinación de sofosbuvir-velpatasvir (SOF/VEL) es una terapia antiviral de acción directa que está autorizada y disponible en México. Esto hace que la evaluación de la respuesta virológica ...sostenida (RVS) 12 semanas después del tratamiento, por medio de la realización de una revisión multicentro en el mundo real, sea una tarea relevante.
Se efectuó una revisión retrospectiva de los registros de 241 casos de pacientes atendidos en 20 hospitales en México para evaluar el tratamiento contra la hepatitis C con la combinación SOF/VEL (n = 231) y sofosbuvir/velpatasvir/ribavirin (SOF/VEL/RBV) (n = 10). El objetivo de eficacia primario fue el porcentaje de pacientes que lograron la RVS 12 semanas posterior a la finalización del tratamiento.
En general, la RVS fue de 98.8% (IC 95% 97.35 a 100%). Solo tres pacientes no lograron la RVS, de los cuales dos padecían cirrosis y una tenía historia previa de tratamiento con interferón pegilado (peg-IFN). De los subgrupos analizados, todos los casos con infección de virus de la inmunodeficiencia humana (VIH), tres con genotipo 3 y aquellos tratados con la combinación SOF/VEL/RBV, lograron RVS. Los subgrupos con tasas menores de éxito fueron los pacientes que tenían experiencia con tratamiento (96.8%) y pacientes con fibrosis F1 (95.5%). Los eventos adversos más frecuentes fueron fatiga, cefalea e insomnio. No se reportaron eventos adversos graves.
Los tratamientos con SOF/VEL y SOF/VEL/RBV fueron altamente seguros y efectivos y los resultados coinciden con los de otros estudios internacionales realizados en el mundo real.
The sofosbuvir-velpatasvir (SOF/VEL) combination is a direct-acting antiviral therapy that is authorized and available in Mexico, making the performance of a real-world multicenter study that evaluates the sustained virologic response at 12 weeks post-treatment a relevant undertaking.
A retrospective review of the case records of 241 patients seen at 20 hospitals in Mexico was conducted to assess hepatitis C treatment with the SOF/VEL combination (n = 231) and the sofosbuvir/velpatasvir/ribavirin (SOF/VEL/RBV) combination (n = 10). The primary efficacy endpoint was the percentage of patients that achieved SVR at 12 weeks after the end of treatment.
Overall SVR was 98.8% (95% CI 97.35-100%). Only three patients did not achieve SVR, two of whom had cirrhosis and a history of previous treatment with peg-IFN. Of the subgroups analyzed, all the patients with HIV coinfection, three patients with genotype 3, and the patients treated with the SOF/VEL/RBV combination achieved SVR. The subgroups with the lower success rates were patients that were treatment-experienced (96.8%) and patients with F1 fibrosis (95.5%). The most frequent adverse events were fatigue, headache, and insomnia. No serious adverse events were reported.
Treatments with SOF/VEL and SOF/VEL/RBV were highly safe and effective, results coinciding with those of other international real-world studies.
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