2017 – Drug Pipeline and Conference Coverage

Protective Effect of Cannabis and Coffee Consumption on HCV-related Mortality in French HIV-HCV Co-Infected Patients – C. Protopopescu, et al.

STUDY: Abstract: THU-048 Protective Effect of Cannabis and Coffee Consumption on HCV-related Mortality in French HIV-HCV Co-Infected Patients – C. Protopopescu, et al.

Study Aims and Results: This study evaluated the effects of cannabis, coffee, alcohol and tobacco used for symptom management by 1,028 HIV-HCV co-infected patients over a median of 5 years. During that time, there were 77 deaths, of which 33 were related to HCV.

Regular/daily cannabis use, drinking ≥3 cups of coffee daily and not smoking were independently associated with a 68%, 63%, and 64% reduction in HCV-related mortality. Researchers did not find a significant association between alcohol consumption and HCV-mortality risk.

Conclusions: These researchers state that this confirmed the benefits of regular use of coffee. Further, it highlights the possible protective role of cannabis.

Editorial Comments: We have seen a great deal of research showing the benefits of coffee, but cannabis research hasn’t yielded consistent results. The French have done most of the cannabis research, and have advanced the theory that cannabis is associated with reduced risk of insulin resistance and steatosis, two conditions linked to increased mortality risk. We need more (and larger) cannabis studies so we can better understand the effect(s) of cannabis on our health as a whole.

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Risk of Liver Fibrosis Progression in Patients with Undiagnosed Hepatitis C Virus Infection – D.E.M. Arraez, et al.

STUDY Abstract: PS-094 Risk of Liver Fibrosis Progression in Patients with Undiagnosed Hepatitis C Virus Infection – D.E.M. Arraez, et al.

Study Aims and Results: This Spanish study investigated the risk of fibrosis progression in patients with unknown hepatitis C virus (HCV) viral load results who tested positive for HCV antibodies. A total of 38,246 HCV antibody tests were performed from 2005–2007 of which 791 (2%) patients tested positive. In the months following the initial test (median 128.6 months), nearly 50% had not received viral load testing. Of these, 13% (n = 103) had undetectable HCV RNA.

Patients who were less likely to have had viral load testing were male, alcohol users, and those lacking in social support. This group had significantly more fibrosis than those who had viral load testing.

Conclusions: This research found that HCV antibody-positive patients who were not followed up with HCV viral load testing, tended to be people who were socially marginalized. This was associated with increased risk of advanced fibrosis and cirrhosis. The researchers encouraged increased support and linkage to care for patients who may be at risk for non-follow-up.

Editorial Comments: I find this study frightening because if this can occur in Spain, a country that provides access to healthcare to all citizens, imagine what happens in the U.S., a country with limited healthcare access. Even worse, what about countries with substandard medical care.

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

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.

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.

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.

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.

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.

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.

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.)

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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.

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.

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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.

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.

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

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.

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Drug Pipeline and Conference Coverage

Hepatitis C Drug Pipeline

Category Archives: 2017

Protective Effect of Cannabis and Coffee Consumption on HCV-related Mortality in French HIV-HCV Co-Infected Patients – C. Protopopescu, et al.

Risk of Liver Fibrosis Progression in Patients with Undiagnosed Hepatitis C Virus Infection – D.E.M. Arraez, et al.

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

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

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

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

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

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

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.

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

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.

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