Hepatitis C Virus Infection in Patients With Cancer: Impact on Clinical Trial Enrollment, Selection of Therapy, and Prognosis

Torres, Harrys A.; Pundhir, Pooja; Mallet, Vincent

doi:10.1053/j.gastro.2019.01.271

Cited by 24 publications

(37 citation statements)

References 38 publications

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“…The study was approved by the Institutional Review Board of MD Anderson Cancer Center, and patients provided written informed consent. DAA therapy was offered to all cancer patients without contraindication for antiviral therapy as previously reported . Treatment was not offered to patients with a life expectancy of <12 months that cannot be remediated by HCV treatment or cancer therapy or to patients with uncontrolled cancer unless the patient was a candidate for a cancer clinical trial .…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Elimination of HCV from infected cancer patients leads to better hepatic, virologic, and oncologic outcomes . HCV eradication improves transaminase levels and delays the progression of liver fibrosis, enabling patients to receive hepatotoxic chemotherapies . Virologic clearance of HCV also improves overall survival, improves disease‐free survival, reduces relapses of HCV‐associated non‐Hodgkin lymphoma, and prevents secondary HCV‐associated cancer .…”

Section: Introductionmentioning

confidence: 99%

“…HCV eradication improves transaminase levels and delays the progression of liver fibrosis, enabling patients to receive hepatotoxic chemotherapies . Virologic clearance of HCV also improves overall survival, improves disease‐free survival, reduces relapses of HCV‐associated non‐Hodgkin lymphoma, and prevents secondary HCV‐associated cancer . HCV infection is an exclusion criterion in many clinical trials, and virologic cure of HCV may give patients more opportunities for clinical trials of treatment for their primary malignancy .…”

Section: Introductionmentioning

confidence: 99%

“…Virologic clearance of HCV also improves overall survival, improves disease‐free survival, reduces relapses of HCV‐associated non‐Hodgkin lymphoma, and prevents secondary HCV‐associated cancer . HCV infection is an exclusion criterion in many clinical trials, and virologic cure of HCV may give patients more opportunities for clinical trials of treatment for their primary malignancy . However, there are no published data regarding the retreatment of HCV‐infected cancer patients with DAAs.…”

Section: Introductionmentioning

confidence: 99%

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Salvage therapy in cancer patients with hepatitis C without sustained virologic response after direct‐acting antivirals—A prospective study

et al. 2019

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Background and Aim No information exists regarding direct‐acting antivirals (DAAs) salvage therapy for Hepatitis C (HCV)‐infected patients with any type of cancer. We prospectively evaluated the safety and efficacy (SVR12) of salvage therapy in these patients. Methods Patients who failed initial DAAs (01/2015–01/2018) were analyzed. Resistance‐associated substitutions to NS5A and NS3 were investigated by population sequencing. Results Of 164 patients enrolled, 16 (10%) experienced treatment failure. Of these, 11 patients received salvage therapy. The majority (91%) were men; 55% had genotype 1a, 45% had cirrhosis, and 45% had hepatocellular carcinoma. Four patients failed the first salvage therapy, and two of them required a second salvage therapy. Overall, 9 of 11 (82%) patients achieved SVR12. All four patients treated with sofosbuvir/velpatasvir/voxilaprevir (+/− ribavirin) achieved SVR12. The presence of resistance‐associated substitutions did not impact response. Seven patients developed grade 1/2 adverse events. No patient had grade 3/4 adverse events. No patient required interruption of DAA therapy because of clinical or laboratory abnormalities. Conclusions This is the first prospective study in HCV‐infected cancer patients failing DAAs. The efficacy of salvage therapy in this group appears to be lower than previously reported in non‐cancer patients, but better response rates are observed with newer regimens. Salvage therapy is associated with minimal toxicity.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Salvage therapy in cancer patients with hepatitis C without sustained virologic response after direct‐acting antivirals—A prospective study

et al. 2019

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Assessing population diversity in phase III trials of cancer drugs supporting Food and Drug Administration approval in solid tumors

Yekedüz

Trapani

et al. 2021

Intl Journal of Cancer

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Our study aimed to assess inequities in the clinical trial participation for the selected patient groups. We searched the Food and Drug Administration (FDA) database and extracted phase‐III clinical trial data from MEDLINE for each approved drug by the FDA between January 1, 2006, and June 30, 2020. We analyzed the inclusion/exclusion criteria, participation according to gender, ethnic group, performance score, the positivity of HBV and HCV, and HIV, having comorbidities and brain metastasis. We compared the findings with that of the general population by retrieving data from the Surveillance, Epidemiology and End Results (SEER) database. We identified 142 phase III pivotal oncology trials that enrolled 105 397 patients. The proportion of female patients in trials was lower than their relative prevalence in the general population from SEER region (36% vs 49.6%, P < .001). The rates of black patients included were lower than their relative prevalence from SEER region (2.1% vs 9.8%, P < .001). 1.3% and 0.8% of patients had HBV and HCV infections, respectively. The patients' numbers with organ dysfunction were not established due to insufficient data from clinical trials. 1.6% of all patients had controlled brain metastasis. Black patients, women and patients with brain metastasis or with HBV and HCV were underrepresented. Our study underscores the importance of expanding the inclusion/exclusion criteria of pivotal oncology trials to be more representative of patients seen in clinical practice.

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Strategies to identify hepatitis C virus infection in patients receiving anticancer therapy: a cross-sectional study

Torres

Lok

Suarez‐Almazor

et al. 2020

Support Care Cancer

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Hepatitis C Virus Infection in Patients With Cancer: Impact on Clinical Trial Enrollment, Selection of Therapy, and Prognosis

Cited by 24 publications

References 38 publications

Salvage therapy in cancer patients with hepatitis C without sustained virologic response after direct‐acting antivirals—A prospective study

Salvage therapy in cancer patients with hepatitis C without sustained virologic response after direct‐acting antivirals—A prospective study

Assessing population diversity in phase III trials of cancer drugs supporting Food and Drug Administration approval in solid tumors

Strategies to identify hepatitis C virus infection in patients receiving anticancer therapy: a cross-sectional study

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