- |||||||||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Sovaldi (sofosbuvir) / Gilead
Trial completion date, Trial primary completion date: A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials (clinicaltrials.gov) - May 21, 2020 P=N/A, N=500, Enrolling by invitation, The combination of sofosbuvir, glecaprevir/pibrentasvir and ribavirin could be a rescue therapy after previous relapses on DAA-therapy, especially in patients with relapse after therapy with sofosbuvir, velpatasvir, and voxilaprevir. Trial completion date: Sep 2027 --> Nov 2024 | Trial primary completion date: Sep 2027 --> Nov 2024
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Clinical, Retrospective data, Journal, Real-World Evidence: Sofosbuvir-based regimens in the treatment of patients with chronic hepatitis C virus infection: Real-world efficacy in Thailand. (Pubmed Central) - May 19, 2020 Collectively, these outcomes will shed the light on MRJP2 and its isoform X1 as two promising safe-inhibitors for both HCV and HBV. Sofosbuvir-based regimens in the treatment of patients with chronic HCV infection were highly efficacious with excellent safety and tolerability profiles in a real-world setting; however, further research is required to establish whether or not such a regimen is an adequate treatment for all genotype 6 patients.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Journal: Knowledge-based repositioning of the anti-HCV direct antiviral agent Sofosbuvir as SARS-CoV-2 treatment. (Pubmed Central) - May 19, 2020 Indeed, the RNA-dependent RNA-polymerases (RdRp) of the two viruses show high sequence and structural homology, supporting the likelihood of binding the Sofosbuvir molecule with similar efficiency. Such a repositioning would allow the containment of the SARS-CoV-2 pandemic and limit the progression of disease to potentially deadly COVID19.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Sovaldi (sofosbuvir) / Gilead
Enrollment closed, Trial completion date, Trial primary completion date: A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study (clinicaltrials.gov) - May 17, 2020 P2, N=135, Active, not recruiting, Trial completion date: Sep 2020 --> Jun 2021 Recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Feb 2020 --> Jul 2020
- |||||||||| Daklinza (daclatasvir) / BMS, lopinavir/ritonavir / Generic mfg.
Journal: Minimum costs to manufacture new treatments for COVID-19. (Pubmed Central) - May 16, 2020 Should repurposed drugs demonstrate efficacy against COVID-19, they could be manufactured profitably at very low costs, for much less than current list prices. Estimations for the minimum production costs can strengthen price negotiations and help ensure affordable access to vital treatment for COVID-19 at low prices globally.
- |||||||||| Copegus (ribavirin) / Bausch Health, Sovaldi (sofosbuvir) / Gilead
The effectiveness of different modes of anti‐viral therapy in patients with hepatitis C‐associated (HCV) lymphoma marginal zone (LMZ) () - May 14, 2020 - Abstract #BSH2020BSH_333; The use of AVT, consisting of interferon (IFN) and ribavirin (RBV) and the new anti‐viral drugs direct action (DAA), at any time during the life of these patients (pts) can cause a high level so anti‐viral anti‐tumour responses...Depending on the treatment the patients were divided into two groups (G): 28(61%) patients received treatment with anti‐viral regime on the basis of IFN (G1), 18 (39%) patients (G2) receive direct anti‐viral drugs (a regimen based on sofosbuvir)...Thus, the duration of DAA therapy should be at least 9 months. Perhaps the combination of these two regimens will increase the effectiveness of treatment for hepatitis C‐associated LMZ
- |||||||||| Sovaldi (sofosbuvir) / Gilead
SUSTAINED VIROLOGIC RESPONSE (SVR) TO DAA TREATMENT RESULTS IN A HIGH AND DURABLE RATE OF BOTH ALT AND AST LOWER THAN 30 (MALES)/19 (FEMALES) IU/L IN HCV-INFECTED PATIENTS () - May 4, 2020 - Abstract #DDW2020DDW_6358; At pre-Rx, only 10.9%, 8.5%, and 5.4% had ALT, AST, or ALT/AST < 30 (M), 19 (F) IU/L, and that increased to 77.3%, 60.2%, and 58.6% at post-Rx wk 48, respectively. Post-Rx wk 48 ALT/AST < 30 (M)/19 (F) IU/L was independently and significantly associated with male gender, both ALT/AST < 30 (M)/19 (F) IU/L at Rx wk 4, and Child score < 6
- |||||||||| Copegus (ribavirin) / Bausch Health, Sovaldi (sofosbuvir) / Gilead
Journal: Antiviral candidates for treating hepatitis E virus infection. (Pubmed Central) - May 1, 2020 Sofosbuvir has previously exhibited mixed results against HEV as an antiviral, both in vitro and in a handful of clinical applications, however in this study it was effective against the HEV genotype 1 replicon (EC 1.97 μM, CC >100 μM) and reduced replicon RNA levels (47.2% reduction at 10 μM). Together these studies indicate drug repurposing may be a promising pathway for development of antivirals against HEV infection.
- |||||||||| pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie, voxilaprevir (GS-9857) / Gilead
Clinical, Journal: Retreatment of Hepatitis C Virus-Infected Patients with Direct-Acting Antiviral Failures. (Pubmed Central) - Apr 30, 2020 The triple combination of sofosbuvir, velpatasvir, and voxilaprevir for 12 weeks is the first-line retreatment strategy in patients previously exposed to DAAs. Difficult-to-retreat patients may benefit from the combination of sofosbuvir plus glecaprevir/pibrentasvir and/or the addition of ribavirin and/or longer retreatment duration.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Clinical, Journal, Real-world evidence: Real-World Study on Sofosbuvir-based Therapies in Asian Americans With Chronic Hepatitis C. (Pubmed Central) - Apr 27, 2020 Trial completion date: Aug 2023 --> Jan 2023 | Trial primary completion date: Aug 2023 --> Jan 2023 In Asian Americans with CHC, SOF-based regimens were well tolerated without serious AEs and could achieve high SVR12 regardless of hepatitis C viral infection GT.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Journal: Potential Use of Sofosbuvir in the Prophylaxis for Rabies. (Pubmed Central) - Apr 25, 2020 In Asian Americans with CHC, SOF-based regimens were well tolerated without serious AEs and could achieve high SVR12 regardless of hepatitis C viral infection GT. No abstract available
- |||||||||| Daklinza (daclatasvir) / BMS, sofosbuvir/velpatasvir / Generic mfg., Sovaldi (sofosbuvir) / Gilead
Clinical, Journal, Real-World Evidence: Real-world Effectiveness of Daclatasvir plus Sofosbuvir and Velpatasvir/Sofosbuvir in Hepatitis C Genotype 2 and 3. (Pubmed Central) - Apr 24, 2020 In genotype 2 and 3 HCV-infected patients, DCV+SOF±RBV and VEL/SOF±RBV produced similar SVR rates within genotype, and regimen did not have a significant impact on odds of SVR. For genotype 3 patients, prior treatment-experience and advanced liver disease were significant predictors of reduced odds of SVR regardless of regimen.
- |||||||||| Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Clinical, Journal, Real-World Evidence: Sofosbuvir-based regimen for genotype 2 HCV infected patients in Taiwan: A real world experience. (Pubmed Central) - Apr 21, 2020 SOF/RBV, SOF/DCV or SOF/DCV/RBV for 12 weeks all achieve very high SVR rates and are equally effective in the treatment of genotype 2 CHC patients in the real world in Taiwan. Patients in the SOF/RBV group who have a history of HCC exhibit a lower SVR rate.
- |||||||||| pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie
Journal: Re-treatment of Hepatitis C Infection After Multiple Failures of Direct-Acting Antiviral Therapy. (Pubmed Central) - Apr 17, 2020 Multiple patient- and virus-related factors that do not affect cure rates in treatment-naive patients may need to be considered in choosing a re-treatment regimen for these patients. These regimens may need to include combinations drugs that are not available in single-tablet form, addition of ribavirin, and longer durations of treatment than standard.
- |||||||||| Copegus (ribavirin) / Bausch Health, Sovaldi (sofosbuvir) / Gilead
Clinical, Journal, Adverse events: Fib-4 Predicts Early Hematological Adverse Events Induced by Interferon-Based Triple Therapy in Chronic Hepatitis C Virus Patients. (Pubmed Central) - Apr 16, 2020 A Fib-4 cutoff value of 3.59 had high specificity for anemia, leukopenia, and neutropenia (85.1%, 87.2%, and 88.2%, respectively), but had low sensitivity for detecting the 3 events. In conclusion, the Fib-4 score may predict early hematological adverse effects in HCV-infected patients on IFN-based triple therapy.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: Pulmonary hypertension in patients with a history of intravenous drug use. (Pubmed Central) - Apr 16, 2020 In conclusion, the Fib-4 score may predict early hematological adverse effects in HCV-infected patients on IFN-based triple therapy. Eliciting a history of intravenous drug use is important and may be associated with a number of less common etiologies, each with specific diagnostic and therapeutic implications.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Sovaldi (sofosbuvir) / Gilead, Cimivir-L (ledipasvir/sofosbuvir) / Gilead, Tehran University of Medical Sciences
Journal: Rescue Therapy for Genotype-3 DAA Non-responders, Almost all Done. (Pubmed Central) - Apr 14, 2020 All the cases achieved sustained virologic response (SVR) at week +12 without adverse effects. In our experience, this combo may represent an effective and safe option for these patients.
- |||||||||| AT-527 / Atea Pharma, Sovaldi (sofosbuvir) / Gilead
Preclinical, Journal: Preclinical evaluation of AT-527, a novel guanosine nucleotide prodrug with potent, pan-genotypic activity against hepatitis C virus. (Pubmed Central) - Apr 10, 2020 When given orally to rats and monkeys, AT-527 preferentially delivered high levels of AT-9010 in the liver in vivo. These favorable preclinical attributes support the ongoing clinical development of AT-527 and suggest that, when used in combination with an HCV DAA from a different class, AT-527 may increase SVR rates, especially for difficult-to-treat patient populations, and could potentially shorten treatment duration for all patients.
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