Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial

Younossi, Zobair M.; Stepanova, Maria; Charlton, Michael; Curry, Michael P.; O’Leary, Jacqueline G.; Brown, Robert S.; Hunt, Sharon

doi:10.1016/s2468-1253(16)30009-7

Cited by 69 publications

(57 citation statements)

References 33 publications

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“…Sofosbuvir (SOF, an NS5B nucleotide polymerase inhibitor) and ledipasvir (LDV, an NS5A inhibitor) used in combination have shown efficacy and safety in HIV‐HCV co‐infected patients similar those observed in HCV‐mono‐infected patients in clinical trials . Furthermore, this and other direct‐acting antiviral (DAA)‐based regimens have been reported to result in substantially improved patient‐reported outcomes (PROs) in both HCV‐mono‐infected and HIV‐HCV co‐infected patients …”

Section: Introductionmentioning

confidence: 99%

Patient‐reported outcomes in patients co‐infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL‐5 study

Younossi

Stepanova

Sulkowski³

et al. 2017

Liver International

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Section: Introductionmentioning

confidence: 99%

Patient‐reported outcomes in patients co‐infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL‐5 study

Younossi

Stepanova

Sulkowski³

et al. 2017

Liver International

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“…Patient-reported outcomes are useful for evaluating adverse effects that are difficult to assess objectively by physicians. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire (6,7) and Patient Neurotoxicity Questionnaire (PNQ) (8) have been utilized to assess patient-reported outcomes of cancer treatments such as chemotherapy or chemoradiotherapy to adjust to sustainable dosage of agents. However, the feasibility and sensitivity of fatigue assessment in patients receiving recent stronger chemotherapy regimen is unknown.…”

Section: Introductionmentioning

confidence: 99%

Prospective validation of patient fatigue questionnaire (FACIT‑F) for fatigue assessment in nab‑paclitaxel plus gemcitabine therapy

et al. 2017

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Abstract. Following the recent introduction of a stronger regimen for pancreatic carcinoma, patients undergoing chemotherapy present high incidences of fatigue. The feasibility and validity of evaluating fatigue by questionnaire for patients with unresectable pancreatic cancer (URPC) receiving this recent regimen of chemotherapy remains unclear. Enrolled patients completed the Functional Assessment of Cancer Therapy-Fatigue questionnaire (FACIT-F, version 4), a questionnaire regarding additional concerns, a numerical rating scale test concerning loss of appetite, an evaluation of degree of pain and sensory disorder, and the Patient Neurotoxicity Questionnaire (PNQ) before undergoing nab-paclitaxel plus gemcitabine therapy. Questionnaires and tests were completed on registration day, and then weekly during therapy over an 8-week period as the initial two cycles of continuous regimen. This trial is registered on the UMIN Clinical Trials Registry (UMIN000021758). Between April 2016 and September 2016, 10 consecutive patients with URPC, including metastatic (n=4) and locally advanced pancreatic (n=6) cancer, were registered, and scheduled for nab-paclitaxel plus gemcitabine therapy. The mean maximum values of fatigue degree increased from mean baseline values in all categories of the questionnaire (6-500%). The degree of fatigue presented a spike pattern over a 4-week scheduled period as one cycle of regimen in time-sequence diagram regarding 10/13 (77%) questionnaires. The PNQ concerning sensory/motor disorder also demonstrated a spike pattern and an increase from the baseline as the number of administrations. It is valid and feasible to assess fatigue by FACIT-F questionnaire for patients with URPC undergoing nab-paclitaxel plus gemcitabine therapy, and to detect detailed changes in accordance with scheduled cycles of chemotherapy regimen.

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“…The results of recent studies using interferon‐ and ribavirin‐free regimens with DAAs have shown an increase in PRO scores, which represent quality of life, in all four validated questionnaires: the Short Form Health Survey, the Functional Assessment of Chronic Illness Therapy‐Fatigue, the Chronic Liver Disease Questionnaire‐HCV Version, and the Work Productivity and Activity Index: Specific Health Problem . This increase in PRO scores was observed in patients with and without cirrhosis …”

Section: Resultsmentioning

confidence: 99%

Toward the elimination of hepatitis C in the United States

Saab

Saggi

et al. 2018

Hepatology

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The emergence of effective direct-acting antiviral (DAA) agents has reignited discussion over the potential for hepatitis C elimination in the United States. Eliminating hepatitis C will require a critical examination of technical feasibility, economic considerations, and social/political attention. Tremendous advancement has been made with the availability of sensitive diagnostic tests and highly effective DAAs capable of achieving sustained viral response (SVR) in more than 95% of patients. Eliminating hepatitis C also requires escalating existing surveillance networks to monitor for new epidemics. All preventive interventions such as clean syringe and needle exchange programs, safe injection sites, opioid substitution therapies, and mental health services need to be expanded. Although costs of DAAs have raised budget concerns for hepatitis C elimination, studies have shown that eliminating hepatitis C will produce a savings of up to 6.5 billion USD annually along with other intangible benefits such as increased work productivity and quality of life. Economic models and meta-analyses strongly suggest universal hepatitis C screening for all adults rather than just for birth cohort and high-risk populations. Social and political factors are at least as important as technical feasibility and economic considerations. Due to lack of promotion and public awareness, HCV elimination efforts continue to receive inadequate funding. Social stigma continues to impede meaningful policy changes. Eliminating hepatitis C is an attainable public health goal that will require intense collaboration and sustained public support. (Hepatology 2018;67:2449-2459).

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Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial

Cited by 69 publications

References 33 publications

Patient‐reported outcomes in patients co‐infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL‐5 study

Patient‐reported outcomes in patients co‐infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL‐5 study

Prospective validation of patient fatigue questionnaire (FACIT‑F) for fatigue assessment in nab‑paclitaxel plus gemcitabine therapy

Toward the elimination of hepatitis C in the United States

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