UNASSIGNED: Direct-acting antiviral (DAA) regimens were approved in 2013 with a response rate exceeding 95% and minimal side effects. The response rate of sofosbuvir and ledipasvir exceeds 95% with minimal side effects.
UNASSIGNED: To identify the effects of this regimen in the eradication of viruses from the patients.Material and methods: A prospective observational, open-label study took place between July 2018 and September 2020. The study included 37 patients, about two-thirds of them were male 23 (62.16%), while females comprised 14 (37.84%). All patients received a combination of sofosbuvir 400 mg and ledipasvir 90 mg in a single oral daily dose according to their weight.
UNASSIGNED: The most common HCV genotype was HCV-4, followed by HCV-1 and HCV-2. And by comparing parameters at baseline, end of the treatment, and 12 weeks after completing the treatment, the laboratory data revealed dramatic drops of all liver function tests, the mean of alanine aminotransferase (ALT) (31.1 ±1.42 IU/l vs. 95.5 ±23.16, p < 0.05), aspartate aminotransferase (AST) (29.86 ±1.75 IU/l vs. 89.19 ±24.83, p < 0.05), total serum bilirubin (TSB) (0.57 ±0.07 mg/dl vs. 1.73 ±0.38 mg/dl, p < 0.05), mean HCV PCR (1605168 ±368223.72), after finishing the treatment course, and 12 weeks after that it was non-detectable (p < 0.05).
UNASSIGNED: Treatment with dose-adjusted oral DAAs (SOF/LED) for 12 weeks was well tolerated in Iraqi children and adolescents infected with chronic HCV infections, with a high success rate and trivial adverse effects.

BACKGROUND: The development of direct-acting antivirals directed against the Hepatitis C Virus has dramatically modified the therapeutic approach to chronic hepatic viral disease. Larger use of such drugs has also led to increasing reports about their adverse effects. This report aimed to describe a case of leucocytoclasic vasculitis following treatment based on the sofosbuvir/ledipasvir regimen with complete disappearance shortly after withdrawal in a 61-year-old patient treated for genotype 1 hepatitis C.
METHODS: A 61-year-old Tunisian woman with a history of hepatitis C virus genotype 1 infection developed palpable purpura in front of low extremity articulation, five weeks after the onset of sofosbuvir/Ledipasvir. The histological examination concluded with leucocytoclasic vasculitis, with total disappearance three days after withdrawal. The pre-therapeutic assessment showed no positivity of Cryoglobulinemia. Anti-neutrophil cytoplasmic antibodies (ANCA) were negative. A sustained viral response was obtained only 5 weeks after treatment without an increase of viral load during follow-up.
CONCLUSIONS: There was a temporal relationship between antiviral treatment and non-ANCA skin vasculitis. The pharmacological department concluded the imputability of antiviral treatment (score I2B2).

UNASSIGNED: To demonstrate the use of a standard dose of ledipasvir (LDV) and sofosbuvir (SOF), with or without ribavirin, to treat hepatitis C and hepatitis C/HIV co-infection in Ukraine.
UNASSIGNED: Eligible HCV viraemic adults from two clinics in Kyiv were treated with LDV/SOF with or without weight-based ribavirin for 12 weeks. Clinical assessments were performed at screening and at week 24, and as needed; treatment was dispensed every 4 weeks. The primary outcome was sustained virologic response (SVR) 12 weeks after treatment, with analysis by intention to treat. Cost per patient was estimated in USD (2018) over the 24-week period.
UNASSIGNED: Of 868 patients included in the study and initiated on therapy, 482 (55.5%) were co-infected with HIV. The common genotypes were 1 (74.1%) and 3 (22%). Overall, SVR was achieved in 831 of the 868 patients (95.7%). SVR in patients with hepatitis C alone and hepatitis C/HIV co-infection was 98.4% and 93.6%, respectively. Adverse events were infrequent and usually mild. Using generic medication, cost per patient was estimated at US$680.
UNASSIGNED: A standard dose of LDV and SOF, with ribavirin as per protocol, resulted in good outcomes for patients with both hepatitis C alone and co-infected with hepatitis C/HIV. Program costs in Ukraine were modest using generic medication.

The efficacy and safety of 12 weeks of therapy with sofosbuvir/ledipasvir in three patients aged 5-10 years are presented. All three children suffered from comorbidities, including chronic kidney disease in two. All participants achieved a sustained virologic response 12 weeks after the end of treatment. No adverse effects were reported during or after the treatment, and the compliance was good. Decisions on starting treatment in children below 6 years of age should be made individually, taking compliance into consideration. The adjustment of formulation and dosing of medication during treatment is necessary in young children. Further research with larger groups of patients is needed to confirm our findings.

OBJECTIVE: Currently, there is no therapy approved for COVID-19. We evaluated the efficacy and safety of sofosbuvir/ledipasvir and nitazoxanide for the treatment of patients with COVID-19 infection.
METHODS: A multicenter, open-label randomized controlled trial included one hundred and ninety patients with non-severe COVID-19 infection. Patients were randomized into three groups. All groups received standard care treatment (SCT). In addition, group 1 received sofosbuvir/ledipasvir, and group 2 received nitazoxanide. Follow-up by reverse-transcriptase polymerase chain reaction (RT-PCR) was done at intervals of 5, 8, 11, and 14 days. The primary endpoint was viral clearance.
RESULTS: Viral clearance was significantly higher in the sofosbuvir/ledipasvir and nitazoxanide groups compared to the SCT group in all follow-up intervals (p < 0.001). In the sofosbuvir/ledipasvir arm, 36.9% showed early viral clearance by day 5. By day 14, 83.1% of the sofosbuvir/ledipasvir group, 39.7% of the nitazoxanide group, and 19.4% of the SCT group tested negative for SARS-CoV-2. Sofosbuvir/ledipasvir and nitazoxanide treatment were the only significant factors in Cox regression of negative RT-PCR with the highest OR (17.88, 95% CI: 6.66-47.98 and 2.59, 95% CI: 1.11-6.07, respectively). No mortality or serious adverse events were recorded.
CONCLUSIONS: The addition of sofosbuvir/ledipasvir or nitazoxanide to the SCT results in an early and high viral clearance rate in mild and moderate patients with COVID-19. These drugs represent a safe and affordable treatment for COVID-19.

COVID-19 is a pandemic disease caused by SARS-CoV-2, which is an RNA virus similar to the hepatitis C virus (HCV) in the replication process. Sofosbuvir/ledipasvir is an approved drug to treat HCV infection. This study investigates the efficacy of Sofosbuvir/ledipasvir as a treatment for patients with moderate COVID-19 infection. This is a single-blinded parallel-randomized controlled trial. The participants were randomized equally into the intervention group that received Sofosbuvir/ledipasvir (S.L. group), and the control group received Oseltamivir, Hydroxychloroquine, and Azithromycin (OCH group). The primary outcomes were the cure rate over time and the incidence of serious adverse events. The secondary outcomes included the laboratory findings. 250 patients were divided equally into each group. Both groups were similar regarding gender, but age was higher in the S.L. group (p=0.001). In the S.L. group, 89 (71.2%) patients were cured, while only 51 (40.8%) patients were cured in the OCH group. The cure rate was significantly higher in the S.L. group (RR=1.75, p<0.001). Kaplan-Meir plot showed a considerably higher cure over time in the S.L. group (Log-rank test, p=0.032). There were no deaths in the S.L. group, but there were six deaths (4.8%) in the OCH group (RR=0.08, p=0.013). Seven patients (5.6%) in the S.L. group and six patients (4.8%) in the OCH group were admitted to the intensive care unit (ICU) (RR=1.17, P=0.776). There were no significant differences between treatment groups regarding total leukocyte and neutrophils count, lymph, and urea. Sofosbuvir/ledipasvir is suggestive of being effective in treating patients with moderate COVID-19 infection. Further studies are needed to compare Sofosbuvir/ledipasvir with new treatment protocols.

Background: Hepatitis C virus (HCV) genotype 1 is the most prevalent HCV infection in China. Sofosbuvir-based direct antiviral agent (DAA) regimens are the current mainstays of treatment. Sofosbuvir/velpatasvir (SOF/VEL) and sofosbuvir/ledipasvir (SOF/LDV) regimens became reimbursable in China in 2020. Thus, this study aimed to identify the optimal SOF-based regimen and to inform efficient use of healthcare resources by optimizing DAA use in treating HCV genotype 1. Methods and Models: A modeling-based cost-utility analysis was conducted from the payer\'s perspective targeting adult Chinese patients with chronic HCV genotype 1 infection. Direct medical costs and health utilities were inputted into a Markov model to simulate lifetime experiences of chronically infected HCV patients after receiving SOF/LDV, SOF/VEL or the traditional strategy of pegylated interferon (pegIFN) + ribavirin (RBV). Discounted lifetime cost and quality adjusted life years (QALYs) were computed and compared to generate the incremental cost utility ratio (ICUR). An ICUR below the threshold of 31,500 $/QALY suggests cost-effectiveness. Deterministic and probabilistic sensitivity analyses were performed to examine the robustness of model findings. Results: Both SOF/LDV and SOF/VEL regimens were dominant to the pegIFN + RBV regimen by creating more QALYs and incurring less cost. SOF/LDV produced 0.542 more QALYs but cost $10,390 less than pegIFN + RBV. Relative to SOF/LDV, SOF/VEL had an ICUR of 168,239 $/QALY which did not meet the cost-effectiveness standard. Therefore SOF/LDV was the optimal strategy. These findings were robust to linear and random variations of model parameters. However, reducing the SOF/VEL price by 40% would make this regimen the most cost-effective option. Conclusions: SOF/LDV was found to be the most cost-effective treatment, and SOF/VEL was also economically dominant to pegIFN + RBV. These findings indicated that replacing pegIFN + RBV with DAA regimens could be a promising strategy.

Background&Aims:Patients with thalassemia have lifelong need for blood transfusion, makes them more risky to hepatitis C virus (HCV). Iron overload and chronic HCV are considered risk factors for patients with thalassemia to develop liver insults. The aim of the present study is to investigate the safety and efficacy of sofosbuvir/ledipasvir in treatment of chronic HCV infection in Egyptian adult patients with β- thalassemia major.
METHODS: Aretrospective study included 53 patients with β-thalassemia major with chronic HCV treated with sofosbuvir (400 mg) and ledipasvir (90 mg) as a single pill fixed dose combination once daily for 12 weeks. The effectiveness of treatment was assessed by sustained virologic response (SVR) at 12 weeks after the end of treatment.
RESULTS: SVR was achieved in 96.23% of patients. 47.17% of patients had minor side effects. There was a significant reduction in ALT, AST, and serum ferritin 12 weeks post-therapy. There was insignificant change in hemoglobin level, or blood transfusion requirement 12 weeks post-therapy. There was no change in iron chelators doses throughout the study period.
CONCLUSIONS: Sofosbuvir/ledipasvir regimen seems to be safe and highly effective in treatment of chronic HCV in patients with β-thalassemia major.

BACKGROUND: Outcome of the liver transplantation (LT) is worse in hepatitis C virus (HCV)/human immunodeficiency virus (HIV)-coinfected patients compared to patients infected with HCV alone. We report the world\'s first case of living donor domino liver transplantation (LDDLT) using a familial amyloid polyneuropathy (FAP) liver in a coinfected recipient with HCV-related liver cirrhosis.
METHODS: The recipient was a 43-year-old male with a CD4 cell count of 52/μL and undetectable HIV-RNA at the time of LT. He received a domino liver graft from a 41-year-old female with FAP. No acute cellular rejection or infection occurred after LT. HCV recurrence was confirmed histologically on the posttransplant day 34. Peginterferon/ribavirin therapy resulted in non-response; however, the patient achieved a sustained viral response with sofosbuvir (SOF)/ledipasvir (LDV). Currently, HCV and HIV testing are negative, and symptomatic de novo amyloidosis has not occurred.
CONCLUSIONS: LDDLT allows successful LT in HCV/HIV-coinfected patients; posttransplant HCV recurrence can be successfully treated with anti-viral therapy.

BACKGROUND: Egypt has the highest prevalence of hepatitis C virus (HCV) infection. Anti-HCV antibodies were detectable in 3% of children in Upper Egypt. Our aim was to evaluate the efficacy of ledipasvir/sofosbuvir for chronic HCV genotype 4 in adolescents with/without hematological disorders and to determine the effect of sustained virological response (SVR) on liver stiffness.
METHODS: Sixty-five adolescents were recruited. There were 3 patient groups: group 1, 44 treatment-naive without hematological disorders; group 2, 6 previously treated; and group 3, 15 treatment-naive with hematological disorders. All patients received sofosbuvir 400 mg/ledipasvir 90 mg per day for 12 weeks. Serum HCV RNA levels were measured before treatment, at week 12, and at 12 weeks after the end of treatment (SVR12). Liver stiffness and the aspartate aminotransferase-platelet ratio index (APRI) score were estimated at baseline and at SVR12.
RESULTS: SVR12 was 100%. At SVR12, there was a significant improvement in liver stiffness in all groups. The APRI score showed significant improvements in groups 1 and 3 (P < .001 and P = .004, respectively). The treatment was well tolerated, with minimal and self-limited side effects.
CONCLUSIONS: Treatment of chronic HCV in adolescents using ledipasvir/sofosbuvir was effective, with a cure rate (at SVR12) of 100%. Significant improvement in liver stiffness was found in all groups.