Category Archives: 2017

CROI 2018: Abstract #163 The Opioid Epidemic and Infectious Diseases: A Public Health Crisis – Sally Hodder

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Abstract #163 The Opioid Epidemic and Infectious Diseases: A Public Health Crisis – Sally Hodder

Summary: In the United States in 2016, there were more than 60,000 drug overdose deaths plus nearly 20,000 additional deaths from viral hepatitis.  The number of acute hepatitis C cases has increased nearly 3-fold from 2010 to 2015; acute hepatitis B has increased 20%. Opioid-related infections are emerging at epidemic proportions.

Editorial Comments: This last abstract was more of a data review and call to action than a study. I included it because these days, hepatitis C will not be eliminated without addressing the opioid crisis. Click here to read the entire abstract.

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CROI 2018: Abstract #609 Predictors of Lack of Hepatitis C Eradication Using Direct-Acting Antivirals – Edward R. Cachay, et al.

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Abstract #609 Predictors of Lack of Hepatitis C Eradication Using Direct-Acting Antivirals – Edward R. Cachay, et al.

Study Aims and Results: This retrospective study sought to identify factors involved in the lack of sustained viral response (SVR) following DAA treatment among people living with HIV (PLWH). Data from the U.S., Spain, and Italy were gathered from 2014 to 2017. Researchers analyzed 450 PLWH looking at: demographics, HIV regimen, CD4, and viral load, HCV-genotype (GT), prior treatment history, and DAA used, fibrosis stage, cirrhosis, and prior liver decompensation. They also looked at comorbidities, active alcohol, illicit drug use, unstable housing and active psychiatric illness.

Overall, 415 patients (92.2%) achieved SVR. Of the 35 failures, 23 were HCV relapses, 9 were lost to follow-up, 2 discontinued DAA therapy due to side effects, and 1 stopped due to a severe comorbidity. Active psychiatric illness was associated with lack of SVR.

Conclusions: Among PLWH, active psychiatric illness was independently associated with lack of SVR to DAA. The researchers recommend exploring the role of drug adherence and/or drug interactions in this population.

Editorial Comments: People with psychiatric illnesses are often left out of studies.  I particularly appreciate the researchers’ recommendations about exploring the role of drug adherence and/or drug interactions in people with psychiatric illness.

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CROI 2018: Abstract #579 Very Low Hepatitis C Viral Loads in Absence of Therapy: Impact on HCV Antigen Testing – Barbara Bertisch, et al.

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Abstract #579 Very Low Hepatitis C Viral Loads in Absence of Therapy: Impact on HCV Antigen Testing – Barbara Bertisch, et al.

Study Aims and Results: HCV antigen testing is a less expensive alternative to viral load testing. However, antigen testing has difficulty detecting very low viral loads (≤ 3,000 IU/ml). This Swiss study assessed the prevalence and analyzed predictors of very low viral loads (VLVL) in 2,460 treatment-naïve participants.

Overall, 5.3% had at least one VLVL. The factors most associated with VLVL are ≤ 40 years old. Gender, HCV genotype and intravenous drug use were not associated with VLVL. Participants with VLVL had a higher rate of spontaneous clearance than those without VLVL. There were 24 cases of cirrhosis, all with either excessive alcohol consumption, HIV coinfection, organ transplantation or other immunosuppressive conditions. The mortality rate was comparable to those without VLVL.

Conclusions: The occurrence of very low viral loads is low. Although the rate of spontaneous clearance is better than expected, the incidence of cirrhosis is disturbing. The use of the HCV antigen assay is questionable as a single tool for HCV detection.

Editorial Comments: Although HCV antigen testing is not the standard assay used in the U.S., this research about very low viral loads is important. Click here to read the entire abstract and view the poster.

 

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CROI 2018; Abstract #606 High Efficacy of 8 Weeks of Ledipasvir/Sofosbuvir in African Americans with HCV – Whitney Nichols, et al.

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Abstract #606 High Efficacy of 8 Weeks of Ledipasvir/Sofosbuvir in African Americans with HCV – Whitney Nichols, et al.

Study Aims and Results: Current HCV guidelines (www.hcvguidelines.org) recommend that African Americans with genotype 1 HCV receive 12 weeks of ledipasvir/sofosbuvir (LDV/SOF), even if they meet criteria for 8 weeks. Research shows conflicting results of treatment outcomes in this group. This retrospective study evaluated the efficacy of 8 weeks of LDV/SOF in African Americans in a real-world setting.

Using data from 2014 to 2017, researchers analyzed data from 59 participants, comparing age, fibrosis level, gender, genotype, medication/treatment adherence, and use of acid-reducing medicines. When comparing 8 weeks to 12 weeks of treatment, they found no significant differences between groups regarding age, genotype, medication and appointment adherence and acid-reducing medication use. However, there were more females, earlier liver fibrosis, and lower baseline viral loads in the 8-week group.

Conclusions: In a real-world setting, 8 weeks of HCV treatment showed good results in African Americans.

Editorial Comments: This study is small and retrospective.  I would not rely on these findings to make treatment decisions. I hope we see some large prospective research on this subject. Click here to read the entire abstract and view the poster.

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CROI 2018: Abstract #600 Increasing Incidence of Denial of DAA Therapy for Chronic HCV by Insurance Type – Charitha Gowda, et al.

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Abstract #600 Increasing Incidence of Denial of DAA Therapy for Chronic HCV by Insurance Type – Charitha Gowda, et al.

Study Aims and Results: When HCV direct-acting antivirals (DAAs) were first approved, insurers restricted access because of the high cost of medications.  Looking for information about current practices, this prospective study analyzed access to HCV treatment between January 1, 2016 and April 30, 2017. Using a national specialty pharmacy, researchers collected data from 9,025 people from 45 states who were prescribed a DAA regimen (4,702 covered by Medicaid; 1,821 by Medicare; 2,502 by commercial insurance). There were 3,200 (35.5%) absolute denials. Absolute denial was more common among patients covered by commercial insurance (52.4%) than by Medicaid (34.5%) or Medicare (14.7%). Analyzing quarterly data, denial of treatment increased per quarter from 27.7% in the first quarter to 43.8% in the last quarter.

Conclusions: Despite the fact that HCV has a high cure rate, treatment denials are high and appear to be increasing.

Editorial Comments: This is outrageous and inhumane. The only way HCV can be eliminated is to improve access to care. Click here to read the entire abstract and view the poster.

 

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Abstract: #974 HCV Clearance Is Associated with an Increase in Cardiovascular Risk – Varun K.Takyar, et al.

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Abstract: #974 HCV Clearance Is Associated with an Increase in Cardiovascular Risk – Varun K.Takyar, et al.

People living with HCV tend to have low lipid profiles (cholesterol and triglycerides). After HCV is eradicated, an increase in lipids is common. Researchers wondered if these higher lipids increases risk of cardiovascular disease. Evaluating 60 subjects undergoing HCV treatment, this small study compared the pre-treatment cardiovascular risk to the 24-week post-treatment risk.

Conclusion: When people cleared HCV, their lipoproteins increased, which in turn raises cardiovascular risk. The researchers recommended that, “Patients should be evaluated for cardiovascular risk and need for lipid lowering therapy after HCV clearance.”

Editorial Comments: I have three problems with this study. First, the study used an extremely small sample. Second, the length of the study; I wonder what these data would be in one, five, and ten years. Third, (and most importantly), this study needs to have a control arm. Other studies show that people with HCV have an increased risk of cardiovascular disease. But, if you read this study, it appears that people who are cured are at increased risk. With no comparison to people without HCV, we don’t really know what the risk is, especially with data that are small and short-term.

Lucinda Porter, RN, is a long-time contributor to the HCV Advocate and author of “Free from Hepatitis C” and “Hepatitis C One Step at a Time.” She blogs at www.LucindaPorterRN.com and HepMag.com

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Abstract: #972 Risk of Parkinson’s Disease in Hepatitis C Patients Following Exposure to Direct-Acting Antiviral Treatment: An Analysis of US Administrative Claims Data – Laura Telep, et al.

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Abstract: #972 Risk of Parkinson’s Disease in Hepatitis C Patients Following Exposure to Direct-Acting Antiviral Treatment: An Analysis of US Administrative Claims Data – Laura Telep, et al.

Previous studies have shown an increased risk of Parkinson’s disease in people with chronic HCV infection, but the data were small. This research analyzed ten years of data collected from 347,052 HCV-positive adults and compared those who were treated for HCV to those who were untreated. The data were further compared to a random sample of 715,220 adults with no HCV diagnosis.

Conclusion: HCV was associated with an increased risk of Parkinson’s. Although people treated with DAAs had a reduced risk of Parkinson’s, there aren’t enough data to determine the significance.

Editorial Comments: Clearly more research is needed, particularly regarding the effects of treatment on Parkinson’s. It seems important to know if people who are cured need to be screened for Parkinson’s, or if treatment reduces the risk.

Also, I learned something new when reviewing this study. People who were treated with interferon (IFN) tended to be younger than people treated with DAAs. So when comparing DAA to IFN treatments, the generally older DAA subjects may be harder to treat and susceptible to side effects.

Note: A second large study presented at the Liver Meeting confirmed the increased risk of Parkinson’s in those with HCV. It did not examine the post-treatment risk. (Abstract 891 Hepatitis C Virus Infection and Risk Of Parkinson Disease: A Systematic Review and Meta-Analysis – Karn Wijarnpreecha, et al.)

Lucinda Porter, RN, is a long-time contributor to the HCV Advocate and author of “Free from Hepatitis C” and “Hepatitis C One Step at a Time.” She blogs at www.LucindaPorterRN.com and HepMag.com

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Abstract: #264 The Frequency of Herbal and Dietary Supplement Mislabeling: Experience of the Drug Induced Liver Injury Network – Victor J. Navarro, et al.

Drug Pipeline and Conference Coverage

Abstract: #264 The Frequency of Herbal and Dietary Supplement Mislabeling: Experience of the Drug Induced Liver Injury Network – Victor J. Navarro, et al.

Herbal and dietary supplements (HDS) are not FDA approved. The Drug Induced Liver Injury Network (DILIN) prospectively collected data on 341 HDS from 1268 enrolled subjects. They analyzed the chemical contents of samples of HDS collected between 2003 and 2016, and compared the contents to the label information.

Conclusion: After chemical analysis, less than half of the herbal and dietary supplements had labels that accurately matched their contents. Bodybuilding and weight loss products had the highest mislabeling rates.

Editorial Comments: Liver injury due to drugs and supplements is increasing at an alarming rate. Do not use supplements without sound medical guidance.

Lucinda Porter, RN, is a long-time contributor to the HCV Advocate and author of “Free from Hepatitis C” and “Hepatitis C One Step at a Time.” She blogs at www.LucindaPorterRN.com and HepMag.com 

To read the entire newsletter, click here

 

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Abstract: #124 Increasing Primary Incidence of Hepatitis C Among HIV-Infected Men Who Have Sex with Men in San Diego; a Pooled Analysis of Two Large Clinics from 2000-2015 – Antoine Chaillon, et al.

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Abstract: #124 Increasing Primary Incidence of Hepatitis C Among HIV-Infected Men Who Have Sex with Men in San Diego; a Pooled Analysis of Two Large Clinics from 2000-2015 – Antoine Chaillon, et al.

This study retrospectively analyzed data collected between 2000 and 2015 from two of the largest HIV clinics in San Diego. Researchers looked for the incidence of HCV among 2768 men who have sex with men (MSM) who tested positive for HIV, but negative for HCV at baseline.

Conclusion: This research reported a significant increase in HCV incidence over time. They also found that compared to those with no history of meth or injection drug use (IDU), HCV incidence was three times higher among HIV+ MSM who reported meth or IDU use.

Editorial Comments: Similar results were reported in European studies. Although HCV is not transmitted efficiently via sex, we need to arm people with facts about the transmission risk, especially among MSMs.

Lucinda Porter, RN, is a long-time contributor to the HCV Advocate and author of “Free from Hepatitis C” and “Hepatitis C One Step at a Time.” She blogs at www.LucindaPorterRN.com and HepMag.com

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Abstract: #55 Cardiovascular Risk in NAFLD–Not an Equal Opportunity: Implications for Women’s Health – Alina M. Allen, et al.

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Abstract: #55 Cardiovascular Risk in NAFLD–Not an Equal Opportunity: Implications for Women’s Health – Alina M. Allen, et al.

People with nonalcoholic fatty liver disease (NAFLD) have a higher risk for cardiovascular (CV) events. This Mayo Clinic study investigated possible sex-related differences in CV risk among people with NAFLD. Using data from the Rochester Epidemiology Project database, researchers looked at 4,196 adults diagnosed with NAFLD in Olmsted County, MN between 1997-2014. Slightly more than half were women (52%). They compared the adults with NAFLD to 15,786 in the general population.

Conclusion: Compared to the general population, women with NAFLD had a significantly higher incidence of CV events, but men did not. Also, CV events occurred at a younger age.

Editorial Comments: NAFLD is potentially serious, but still under the radar. It’s time to step up awareness about NAFLD, especially regarding women.

Lucinda Porter, RN, is a long-time contributor to the HCV Advocate and author of “Free from Hepatitis C” and “Hepatitis C One Step at a Time.” She blogs at www.LucindaPorterRN.com and HepMag.com

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Abstract: #997 Increase in Hepatocellular Carcinoma (HCC) in Hepatitis C (HCV) Patients Without Cirrhosis – Sanath K.Allampati, et al.

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Abstract: #997 Increase in Hepatocellular Carcinoma (HCC) in Hepatitis C (HCV) Patients Without Cirrhosis – Sanath K.Allampati, et al.

This study examined the prevalence and trends in HCV-related HCC from 2000 to 2015. Researchers used electronic medical record data obtained from 2,328 subjects diagnosed with HCC; 20% of the subjects did not have cirrhosis at presentation.

Conclusion: HCV-related HCC trended consistently higher. It was more pronounced in the non-cirrhotic group increasing from 9.6% to 21.7%. The researchers recommend screening non-cirrhotic HCV patients for HCC. Additionally, they state that with the advent of DAAs, there is a concern that a large number of HCV-cured patients might potentially go on to develop HCC even though they do not have cirrhosis.

Editorial Comments: Typically, HCV patients who are successfully treated are pronounced cured with no further follow up recommendation. However, this study indicates a potential need for screening HCV-cured patients for HCC. I hope we see guidelines addressing this.

Lucinda Porter, RN, is a long-time contributor to the HCV Advocate and author of “Free from Hepatitis C” and “Hepatitis C One Step at a Time.” She blogs at www.LucindaPorterRN.com and HepMag.com

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Abstract: #142 Eradication of HCV Induced by Direct-Acting Antivirals Is Associated with a 79% Reduction in HCC Risk. – George N. Ioannou, et al.

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Abstract: #142 Eradication of HCV Induced by Direct-Acting Antivirals Is Associated with a 79% Reduction in HCC Risk. – George N. Ioannou, et al.

The goal of this large study was to evaluate the risk of hepatocellular carcinoma (HCC) in people diagnosed with HCV who experienced a viral cure (SVR) using DAAs. Further, this research compared the HCC risk for SVRs achieved by DAAs versus interferon-based regimens.

This research used data collected from 62,051 patients who underwent 83,695 antiviral treatment regimens in the Veterans Affairs national healthcare system from 1999-2015. There were 35,873 (57%) interferon-only regimens; 26,178 (43%) DAA ±interferon regimens; 21,644 (35%) DAA-only regimens.

Conclusion: Among all patients, SVR was associated with a 70% reduction in HCC risk. The risk of HCC was highest among patients with cirrhosis who failed treatment. Patients with cirrhosis who had an SVR had the next highest risk of HCC. The lowest risk was among patients without cirrhosis who achieved SVR, followed by those with no cirrhosis who did not have an SVR. Patients with an SVR following DAA treatment had a 79% reduction in HCC risk.

Editorial Comments: This is one of many studies that reported similar findings. The size of this study strongly enforces the notion that curing HCV with DAAs should be initiated early, and offered to everyone with HCV.

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Lucinda Porter, RN, is a long-time contributor to the HCV Advocate and author of “Free from Hepatitis C” and “Hepatitis C One Step at a Time.” She blogs at www.LucindaPorterRN.com and HepMag.com

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