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  • 1
    Online Resource
    Online Resource
    Quantitative Hepatitis B Surface Antigen Analysis in Hepatitis B E Antigen-Positive Nucleoside-Naive Patients Treated with Entecavir
    SAGE Publications ; 2013
    In:  Antiviral Therapy Vol. 18, No. 5 ( 2013-07), p. 691-698
    Details
    In: Antiviral Therapy, SAGE Publications, Vol. 18, No. 5 ( 2013-07), p. 691-698
    Abstract: Entecavir is a potent nucleoside analogue for treating chronic hepatitis B (CHB). Quantitative hepatitis B surface antigen (qHBsAg) levels are predictive of response to interferon-α in CHB treatment; however, the clinical utility of qHBsAg in nucleoside/ nucleotide analogue-based CHB therapy is not fully characterized. This study assessed changes in qHBsAg in patients treated with entecavir in the Phase III study ETV-022. Methods This retrospective post hoc analysis included nucleoside/nucleotide-naive, hepatitis B e antigen (HBeAg)-positive patients receiving entecavir (0.5 mg daily) in ETV-022 who had samples available for qHBsAg analysis through week 48. qHBsAg, HBV DNA and alanine aminotransferase levels were assessed for the overall patient cohort, for cohorts with or without HBeAg loss or HBsAg loss by week 48, and by HBV genotype. Results Overall, 95 patients from ETV-022 had available samples for qHBsAg analysis through week 48. In all cohorts, 48 weeks of entecavir therapy resulted in effective HBV DNA suppression. In the overall cohort, qHB-sAg declined by -0.92 log 10 IU/ml through week 48. The decline in qHBsAg was more pronounced in patients with subsequent HBeAg loss or HBsAg loss, and in patients infected with HBV genotype D or A. On-treatment qHBsAg changes did not correlate with changes in HBV DNA; no on-treatment or baseline factor was found to be predictive of HBeAg loss or HBsAg loss. Conclusions Through 48 weeks of entecavir therapy, qHBsAg declined predominantly in those patients who achieved seroclearance of HBeAg or HBsAg. However, unlike with interferon-α-based therapy, early qHBsAg decline was not predictive of serological response at year 1 of entecavir treatment.
    Type of Medium: Online Resource
    ISSN: 1359-6535 , 2040-2058
    URL: Article
    DOI: 10.3851/IMP2559
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2013
    detail.hit.zdb_id: 2118396-X
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  • 2
    Online Resource
    Online Resource
    RNA Interference and Its Potential Applications to Chronic HBV Treatment: Results of a Phase I Safety and Tolerability Study
    SAGE Publications ; 2011
    In:  Antiviral Therapy Vol. 16, No. 4 ( 2011-05), p. 547-554
    Details
    In: Antiviral Therapy, SAGE Publications, Vol. 16, No. 4 ( 2011-05), p. 547-554
    Abstract: RNA interference (RNAi) provides an attractive tool to modulate biological systems, and ultimately, to treat human diseases. We describe early results from a Phase Ib, first-in-human safety and tolerability study of an RNAi-based therapy, NUC B1000, among patients with mild to moderate chronic HBV. Methods Three subjects received a single 5 mg DNA dose of NUC B1000 as part of a planned dose escalation study. Results All participants reported pharyngitis, chills, myalgia and fever approximately 4–7 h after dosing. All subjects were asymptomatic after a single antipyretic dose with no symptom recurrences. Measurements of interferon (IFN)-α and -γ, interleukin (IL)-10, 12 18, 8 and 6, and tumour necrosis factor-α performed before and after dosing revealed cytokine increases before study drug administration. After drug administration, IFN-γ and IL-10 increased in two patients; IL-8 increased in one. Most increases returned to pretreatment levels within 1 week. Two patients were subsequently successfully treated with entecavir indicating that NUC B1000 does not compromise subsequent antiviral therapy. Conclusions Thus far, NUC B1000 appears safe and well-tolerated; safety and efficacy studies across a larger, more diverse patient spectrum using increasing doses are needed to determine its appropriate role in the antiviral armamentarium.
    Type of Medium: Online Resource
    ISSN: 1359-6535 , 2040-2058
    URL: Article
    DOI: 10.3851/IMP1798
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2011
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  • 3
    Online Resource
    Online Resource
    Chronic HBV Infection outside Treatment Guidelines: Is Treatment Needed?
    SAGE Publications ; 2013
    In:  Antiviral Therapy Vol. 18, No. 2 ( 2013-02), p. 229-235
    Details
    In: Antiviral Therapy, SAGE Publications, Vol. 18, No. 2 ( 2013-02), p. 229-235
    Abstract: There are now seven antivirals approved for use in the management of chronic HBV infection in the US. Current professional guidelines recommend the use of antiviral treatment in only a distinct subset of the total HBV chronically infected population, estimated to be more than 350 million worldwide. The subset of chronically HBV-infected individuals for whom the antivirals have been demonstrated to produce desirable outcomes are those with abnormal liver enzymes and a viral load above a defined threshold, presumably identifying those at highest risk for development of cirrhosis and hepatocellular carcinoma. However, some individuals whose clinical features place them outside these guidelines, for whom treatment is not recommended, are also at significant risk for liver disease complications and liver-related death. Methods In this report, we produce new estimates of the age-specific risks of liver-related death in people outside the current treatment guidelines using published data from multiple populations. Results Our results indicate that the age-specific 10-year risks of liver-related mortality in these individuals range from 0.3–4% in the West to 0.3–20% in Asia. Conclusions The magnitude of these risks and the estimated size of the global population that falls outside of current treatment guidelines have led us to consider whether medical interventions are also needed for these individuals, either with currently approved therapeutics or yet-to-be-discovered medications targeting new mechanisms of antiviral effect. Potential targets for development of new medications are discussed.
    Type of Medium: Online Resource
    ISSN: 1359-6535 , 2040-2058
    URL: Article
    DOI: 10.3851/IMP2325
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2013
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  • 4
    Online Resource
    Online Resource
    Future Therapies for Hepatitis C
    SAGE Publications ; 2006
    In:  Antiviral Therapy Vol. 11, No. 4 ( 2006-05), p. 397-408
    Details
    In: Antiviral Therapy, SAGE Publications, Vol. 11, No. 4 ( 2006-05), p. 397-408
    Abstract: Although pegylated interferon-α plus ribavirin has become the standard for treating chronic hepatitis C virus infection, a substantial number of patients do not tolerate therapy and require dose reduction or discontinuation, or do not respond to this combination therapy. Thus, new therapeutic options are needed. An increased knowledge of the hepatitis C virus and an understanding of its replication cycle, as well as advances in biotechnology, have stimulated the development of numerous new antiviral treatments for patients with hepatitis C virus infection. This review focuses on four classes of new agents: new interferons, ribavirin-like molecules, specific small-molecule hepatitis C virus inhibitors and new immune therapies, with particular emphasis on medications in the later stages of development.
    Type of Medium: Online Resource
    ISSN: 1359-6535 , 2040-2058
    URL: Article
    DOI: 10.1177/135965350601100415
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2006
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  • 5
    Online Resource
    Online Resource
    Active site polymerase inhibitor nucleotides (ASPINs): Potential agents for chronic HBV cure regimens
    SAGE Publications ; 2022
    In:  Antiviral Chemistry and Chemotherapy Vol. 30 ( 2022-01), p. 204020662211387-
    Details
    In: Antiviral Chemistry and Chemotherapy, SAGE Publications, Vol. 30 ( 2022-01), p. 204020662211387-
    Abstract: Chronic hepatitis B virus (HBV) infection affects 240 to 300 million people worldwide. In the nucleus of infected hepatocytes, the HBV genome is converted to covalently closed circular DNA (cccDNA), which persists and serves as a transcriptional template for viral progeny. Therefore, a long-term cure for chronic HBV infection will require elimination of cccDNA. Although currently available nucleos(t)ide analogues (eg, tenofovir disoproxil fumarate, tenofovir alafenamide, entecavir) effectively control HBV replication, they are seldom curative (functional cure rate ∼10%) and require lifelong treatment for most patients. As such, antiviral agents with novel mechanisms of action are needed. Active site polymerase inhibitor nucleotides (ASPINs) noncompetitively distort the HBV polymerase active site to completely inhibit all polymerase functions, unlike traditional chain-terminating nucleos(t)ide analogues, which only target select polymerase functions and are consumed in the process. Clevudine, a first-generation ASPIN, demonstrated potent and prolonged HBV suppression in phase 2 and 3 clinical studies, but long-term treatment was associated with reversible myopathy in a small number of patients. ATI-2173, a novel next-generation ASPIN, is structurally similar to clevudine but targets the liver and demonstrates potent anti-HBV activity on and off treatment, and may ultimately demonstrate an improved pharmacokinetic and safety profile by significantly reducing systemic clevudine exposure. Thus, ATI-2173 is currently in clinical development as an agent for HBV cure. Here, we review the mechanism of action and preclinical and clinical profiles of clevudine and ATI-2173 to support the role of ASPINs as part of curative regimens for chronic HBV infection.
    Type of Medium: Online Resource
    ISSN: 0956-3202 , 2040-2066
    URL: Article
    DOI: 10.1177/20402066221138705
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2130088-4
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  • 6
    Online Resource
    Online Resource
    Direct-acting antivirals for the treatment of chronic hepatitis C in patients with chronic kidney disease
    SAGE Publications ; 2016
    In:  Therapeutic Advances in Gastroenterology Vol. 9, No. 6 ( 2016-11), p. 887-897
    Details
    In: Therapeutic Advances in Gastroenterology, SAGE Publications, Vol. 9, No. 6 ( 2016-11), p. 887-897
    Abstract: All-oral, direct-acting antivirals (DAAs) have significantly improved the efficacy and safety of chronic hepatitis C (CHC) treatment but their effectiveness and safety among patients with chronic kidney disease (CKD) remains poorly understood. Our aim was to assess the efficacy and safety of DAAs for treatment of CKD patients. The National Library of Medicine through PubMed was searched for studies evaluating the efficacy of DAAs for the treatment of patients with CKD stages 4 or 5, as defined by the Kidney Disease Outcomes Quality Initiative guidelines [i.e. glomerular filtration rate (GFR) 15–29 ml/min per 1.73 m 2 and GFR 〈 15 ml/min per 1.73 m 2 , respectively, or hemodialysis or peritoneal dialysis]. Randomized clinical trials (RCTs) and relevant cohort studies were included if they were published in English and included sustained viral response after 12 weeks (SVR12) as a primary or secondary endpoint. After applying inclusion and exclusion criteria, eight studies (one RCT and seven cohort studies) following 350 patients were selected. For patients with CKD stage 4 or 5, ± hemodialysis, the overwhelming majority of DAA regimens were well-tolerated and resulted in SVR12 rates of 90–100%. Most studies were small, with the exception of one RCT evaluating elbasvir and grazoprevir. Overall, treatment of CHC in patients with CKD is highly effective with SVR12 rates similar to those seen in patients without CKD and with acceptable adverse event profiles. In patients with hepatitis C virus (HCV) genotype (GT) 1a, 1b or 4 and Stage 4 or 5 CKD, the best evidence available is for the use of elbasvir and grazoprevir. This combination as well as the combination of paritaprevir/ritonavir/ombitasvir/dasabuvir for HCV GT-1b are recommended. More studies are needed to assess efficacy and adverse effects of DAAs and their impact on CKD patients and to fully elucidate the effect of curing CHC on the natural history and sequelae of renal disease in CHC patients with CKD.
    Type of Medium: Online Resource
    ISSN: 1756-2848 , 1756-2848
    URL: Article
    DOI: 10.1177/1756283X16665254
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
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