Sofosbuvir

Rose, Lucia; Bias, Tiffany; Mathias, Clinton B.; Trooskin, Stacey; Fong, Jeffrey

doi:10.1177/1060028014534194

Cited by 51 publications

(19 citation statements)

References 53 publications

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“…Treatment of chronic hepatitis C (HCV) infection in the United States has been revolutionized with the development of novel direct-acting antiviral (DAA) therapies. DAA therapy has demonstrated better tolerability, adherence, as well as rates of sustained virologic response (SVR) and cure compared to antecedent interferon (IFN)-based therapies [ 1 – 4 ]. This advance has expanded the population of individuals with HCV infection who are potentially treatable.…”

Section: Introductionmentioning

confidence: 99%

Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade

Mittal

Liapakis

et al. 2015

PLoS ONE

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BackgroundNew treatments for hepatitis C (HCV) infection hold great promise for cure, but numerous challenges to diagnosing, establishing care, and receiving therapy exist. There are limited data on insurance authorization for these medications.Materials and MethodsWe performed a retrospective chart review of patients receiving sofosbuvir/ledipasvir (SOF/LED) from October 11-December 31, 2014 to determine rates and timing of drug authorization. We also determined predictors of approval, and those factors associated with faster decision and approval times.ResultsOf 174 patients prescribed HCV therapy during this period, 129 requests were made for SOF/LED, of whom 100 (77.5%) received initial approval, and an additional 17 patients (13.9%) ultimately received approval through the appeals process. Faster approval times were seen in patients with Child-Pugh Class B disease (14.4 vs. 24.7 days, p = 0.048). A higher proportion of patients were initially approved in those with Medicare/Medicaid coverage (92.2% vs. 71.4%, p = 0.002) and those with baseline viral load ≥6 million IU/mL (84.1% vs. 62.5%, p = 0.040). Linear regression modeling identified advanced fibrosis, high Model of End Stage Liver Disease (MELD) score, and female gender as significant predictors of shorter decision and approval times. On logistic regression, Medicare/Medicaid coverage (OR 5.96, 95% CI 1.66–21.48) and high viral load (OR 4.52, 95% CI 1.08–19.08) were significant predictors for initial approval.ConclusionsEarly analysis of real-world drug authorization outcomes between October-December 2014 reveals that nearly one in four patients are initially denied access to SOF/LED upon initial prescription, although most patients are eventually approved through appeal, which delays treatment initiation. Having Medicare/Medicaid and advanced liver disease resulted in a higher likelihood of approval as well as earlier decision and approval times. More studies are needed to determine factors resulting in higher likelihood of denial and to evaluate approval rates and times after implementation of restrictive prior authorization guidelines.

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Section: Introductionmentioning

confidence: 99%

Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade

Mittal

Liapakis

et al. 2015

PLoS ONE

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“…48 It is a phosphoramidate prodrug and needs to be converted to its active metabolite (GS-461203) within hepatocytes. 49 The phosphoramidate moiety of the prodrug improves bioavailability and transport into hepatocytes. It can be taken with or without food.…”

Section: Sofosbuvir and Simeprevirmentioning

confidence: 99%

“… 50 As a uridine nucleotide analogue, GS-461203 binds to the NS5B catalytic site, induces chain termination, and increases the number of errors in the growing RNA chain. 49 It has activity against HCV genotypes 1 through 6 in vitro . 50 The pharmacokinetic properties of sofosbuvir are shown in Table 3 .…”

Section: Sofosbuvir and Simeprevirmentioning

confidence: 99%

Interferon-Free Treatments for Chronic Hepatitis C Genotype 1 Infection

FakhriRavari

Malakouti

Brady

2016

JCTH

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Hepatitis C virus (HCV) infection affects as many as 185 million people globally, many of whom are chronically infected and progress over time to cirrhosis, decompensated liver disease, hepatocellular carcinoma, and eventually death without a liver transplant. In the United States, HCV genotype 1 constitutes about 75% of all infections. While interferon and ribavirin therapy was the cornerstone of treatment for many years, interferon-free treatments have become the standard of care with the emergence of new direct-acting agents, resulting in more effective treatment, shorter duration of therapy, better tolerability, lower pill burden, and ultimately better adherence. This review will summarize the evidence for the currently available combination therapies as well as emerging therapies in phase 3 trials for treatment of HCV genotype 1.

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“…These patients should be treated as soon as possible. However, ribavirin has various specific side effects that affect tolerability, such as hemolytic anemia, fatigue, cough, depression, and chest pain[ 6 , 7 ], whereas sofosbuvir is tolerable with minimal adverse effects[ 8 ]. In our previous study of low-dose pegylated IFN plus ribavirin therapy for elderly and/or cirrhotic patients infected with HCV genotype 2, drug dose reduction or interruption rates among nonelderly cirrhotic patients, elderly noncirrhotic patients, and elderly cirrhotic patients were all relatively high (65%, 63%, and 77%, respectively)[ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Sofosbuvir plus ribavirin is tolerable and effective even in elderly patients 75-years-old and over

Tamai

Shingaki

Ida

et al. 2020

WJH

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BACKGROUND Although clinical use of sofosbuvir plus ribavirin has been approved for patients infected with genotype 2 hepatitis C virus, patients ≥ 75-years-old have not been included in previous clinical trials. AIM To evaluate the real-world safety and efficacy of sofosbuvir plus ribavirin for elderly patients (≥ 75-years-old) compared to nonelderly patients, we conducted a post-marketing prospective cohort study. METHODS We treated 265 patients with genotype 2 hepatitis C virus using standard approved doses of sofosbuvir (400 mg/d) plus ribavirin adjusted by body weight, administered orally for 12 wk. RESULTS Sustained virological response rates for the overall cohort, patients < 65-years-old, ≥ 65-years-old but < 75-years-old, and ≥ 75-years-old were 97% (258/265), 98% (93/95), 97% (84/87), and 98% (81/83), respectively ( P = 0.842). Logistic regression analyses identified history of hepatocellular carcinoma treatment and alpha-fetoprotein as factors significantly associated with sustained virological response. Alpha-fetoprotein was the only independent factor identified. Sustained virological response rate was significantly lower for patients with hepatocellular carcinoma treatment (91%) than for patients without history of hepatocellular carcinoma treatment (98%, P = 0.004). One patient (0.4%) discontinued treatment due to drug-induced pneumonia. Dose reduction or interruption of ribavirin was required for 12.1% (32/265) of patients because of anemia, including 7.7% (14/182) of patients < 75-years-old and 21.7% (18/83) of patients ≥ 75-years-old ( P = 0.002). CONCLUSION Although ribavirin dose reduction or interruption was required with advanced age, sofosbuvir plus ribavirin appears tolerable and highly effective even in patients ≥ 75-years-old.

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Sofosbuvir

Cited by 51 publications

References 53 publications

Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade

Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade

Interferon-Free Treatments for Chronic Hepatitis C Genotype 1 Infection

Sofosbuvir plus ribavirin is tolerable and effective even in elderly patients 75-years-old and over

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