Eradication of hepatitis C virus (HCV) is going to be difficult despite the huge improvements in treatment. One obstacle that has been highlighted previously has been the increase in HCV transmission associated with the opioid epidemic. Another basic problem is establishing a ‘cascade of care’ that makes sure that those with HCV receive appropriate treatment and followup.
In a recent study (RL Epstein et al. J Pediatr 2018; 203: 34-40, editoria by KB Schwarz, W Karnsakul 7-8) describe the deficiencies in the followup of women in an obstetric clinic serving women with substance use disorders. The authors reviewed electronic records of 879 women over a 10 year period. Key findings:
- 85% of women were screened for HCV. Of the 68% who were seropositive, only 72% had HCV RNA testing and 71% were viremic.
- There were 404 infants born to women who were HCVB seropositive. Only 45% of these infants completed AAP-recommended perinatal HCV screening.
In the commentary, the authors point to the suboptimal rates of followup. They note that there is a “huge gap between infected women and the linkage of their infected progency to care.” Furthermore, the AASLD has recommended that “all children with HCV infection in age groups for which direct-acting antiviral agents are approved should be treated.”
My take: this study identifies gaps in followup and treatment that need to be addressed systematically if we are to realize the goal of HCV eradication.
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FDA Announcement Aug 3, 2017: FDA approves Mavyret for Hepatitis C
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more.
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Gravelly Point, Arlington, VA
JA Flemming et al. Hepatology 2017; 65: 804-12. This cohort study (2003-2015) of 47,591 adults wait-listed for liver transplantation, using the SRTR registry, showed that the era of direct-acting antivirals for hepatitis C was associated with a drop of 32% for HCV patients who were listed compared to the numbers listed during the interferon era.
AG Feldman et al. J Pediatr 2017; 182: 217-22. This retrospective study showed that elevated lactate levels (≥2.5 mmol/L) and elevated lactate to pyruvate ratio (≥25) were NOT predictive of mitochondrial diseases in pediatric patients who presented with acute liver failure.
AG Feldman et al. J Pediatr 2017; 182: 232-38. This retrospective cohort study showed a high rate of vaccine preventable illnesses (VPIs) following liver transplantation (n=2554), occurring in 1 of 6 liver transplant recipients. Most common infections was RSV; most common VPIs: rotavirus and influenza
Saint Chappelle, Paris
Following FDA approval of Zepatier (Elbasvir/Grazopresvir) (related blog post:In brief: Pediatric HCV trial, Exercise for NAFLD, and … – gutsandgrowth), it is gratifying to see reductions in the cost of HCV treatment. Merck has priced Zepatier at $54,600 for a 12-week course which is substantially lower than Sovaldi ($84.000), Harvoni ($94.500), and Viekira Pak ($83,000).
Zepatier is indicated for genotypes 1 and 4 and can be used in patients with severe renal impairment, including dialysis. It is likely that this will pressure rival drug companies to lower their prices as well.
More information: Will Zepatier Shake Up the HCV Market? This link is to an issue of “Specialty Pharmacy Continuum” but interestingly this same story (?verbatim) was published months later by “Gastroenterology and Endoscopy New” (August 2016) without acknowledging the previous publication (by same author).
Grinnell Glacier Trail, Glacier Nat’l Park
The August issue of Hepatology had several articles on Hepatitis C confirming the efficacy of newer agents:
- LI Backus et al Hepatology 2016; 64: 405-14. This “real-world” observational study from the VA Clinical registry with 4,365 genotype 1 treatment-naive patients who received ledipasvir/sofosbuvir showed SVR rates of 91.3% (w/o ribavirin) and 92% (w ribavirin).
- P Kwo et al. Hepatology 2016; 64: 370-80 (OPTIMIST-1) This study showed that 12 weeks of simeprevir+sofusbuvir for 12 weeks was highly effective (97% SVR) and that 8 weeks of this therapy was inferior (83% SVR). N=310 with genotype 1 (w/o cirrhosis). No patients stopped therapy due to adverse effects.
- E Lawitz et al. Hepatology 2016; 64: 360-69 (OPTIMIST-2) This study showed that simeprevir+sofusbuvir for 12 weeks was effective in genotype 1 patients (n=103) with cirrhosis. For treatment-naive, the SVR was 88% and for treatment-experienced patients, the SVR was 79%.
Also in Hepatology:
- S Heibani et al Hepatology 2016; 64: 549-55. This study looked at 1-week versus 2-week intervals for endoscopic ligation. While 1-week ligation eradicated varices more quickly, neither approach was associated with differences in number of endoscopies, complications (including rebleeding) or other clinical outcomes.
The large randomized pediatric entecavir study for Hepatitis B virus (HBV) is now in print: MM Jonas et al. Hepatology 2016; 63: 377-87. Full link to this study on previous blog: Pediatric Entecavir Data This study has led to FDA approval for use of entecavir in children as young as 2 years. One interesting aspect of the study was the 2.6% drug resistance rate in the second year of the study. This further validates current recommendations to treat children with “immune active” phases (e.g. abnormal transaminases and abnormal histology).
H Roberts et al. Hepatology 2016; 63: 388-97. This study provides prevalence data for chronic HBV, 1988-2012. During 2011-12, there were approximately 850,000 Americans with chronic HBV infections. Migration of persons from HBV endemic countries has “largely contributed to prevalence rates remaining constant since 1999.”
JM Wilder et al. Hepatology 2016; 63: 437-44. This study showed that ledipasvir/sofosbuvir was similarly effective in black and non-black patients, with SVR12 rates of 95% and 97% respectively. This is important because older interferon-based treatments were much less effective in black patients.
TB Dick et al. Hepatology 2016; 63: 634-43. This review provides in-depth guidance regarding drug-drug interactions relevant to the new direct-acting antiviral agents used to treat Hepatitis C viral infection.
NY City Data for HIV, HBV, HCV
From AASLD: AASLD Financial Help for patients with HCV
Are your patients struggling to afford the costs of Hepatitis C treatments?
A new program through the HealthWell Foundation may be able to help. The HealthWell Foundation has launched a new Hepatitis C Fund. The fund provides copayment assistance to eligible patients to ease the burden of out-of-pocket costs associated with the treatment of Hepatitis C. Since 2004, HealthWell has assisted more than 200,000 adults and children faced with medical emergencies in paying for life-changing treatments they otherwise would not be able to afford. These patients have insurance, and yet cannot afford their part. To determine eligibility and apply for assistance through the HealthWell Foundation’s Hepatitis C Fund, visit HealthWell’s website. Please lend a hand by spreading the word about the fund.
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