Doubt expressed about potential of any single regimen to treat all hep C

 

PHILADELPHIA – Despite combination therapies for hepatitis C virus (HCV) that are now showing high rates of sustained viral remission (SVR) across all genotypes, a one-size-fits-all treatment will not be practical in the near future, according to a review of current and coming HCV therapies at Digestive Diseases: New Advances meeting held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

 

The focus for improving HCV care is “now shifting, I think, from this one-size-fits-all treatment to identifying, really, the one-size-fits all provider,” reported Kimberly A. Brown, MD, division head of gastroenterology/hepatology at Henry Ford Health System, Detroit.

Courtesy US. Dept of Veterans Affairs

There is no question that the most effective one-pill combinations of direct–acting antiviral (DAA) agents are simplifying treatment strategies. “Many of the special populations have dissolved into what I would now consider to be special considerations,” according to Dr. Brown. However, she cautioned that HCV management still requires skills for individualizing care.

The presence of cirrhosis in some patients demonstrates the need for this care, for example. Many of the most effective single-pill DAA combinations are demonstrating high SVR rates for HCV patients with cirrhosis, but Dr. Brown said that identification of cirrhosis prior to HCV treatment “remains imperative.” Some pangenotypic therapies require a longer duration of treatment when cirrhosis is present, and patients with cirrhosis require posttreatment monitoring for decompensation and hepatocellular carcinoma (HCC). Patients who have failed a prior anti-HCV regimen or who are in renal failure also require more individualized care.

“There is no current therapy in my opinion that allows for one combination, for one length of treatment, without consideration of any patient characteristics,” Dr. Brown said at the meeting. Although several newer combination drugs with pangenotypic properties are likely to be approved for HCV in 2017, Dr. Brown believes that the one-size-fits-all ideal is not going to be fulfilled “anytime soon.”

However, Dr. Brown does believe that HCV care can and should be shifted to trained primary care providers in order to increase the proportion of infected patients who are treated. She indicated that the pangenotypic drugs are making this easier to accomplish and cited a study from the most recent annual meeting of the American Society for the Study of Liver Diseases that showed comparable SVR rates for primary care physicians, nurse practitioners, and specialists when the primary care clinicians underwent a uniform 3-hour training program (Emmanuel B. et al. AASLD 2016;Abstract 22).

“There is an evidence basis for shifting care to primary care providers in order to expand treatment, but, certainly, these providers must have an interest,” Dr. Brown said. She also said that treatment from a primary care provider must be accompanied by follow-up care, which, for example, might include clinics specializing in alcohol or drug dependency.

In treatment-naive patients with uncomplicated HCV, nearly 100% of patients will achieve an SVR on 8-12 weeks of therapy, regardless of genotype, with the newest and most potent DAA regimens, according to data cited by Dr. Brown. However, she cautioned that, even in these patients, it would be inaccurate to conclude that one-size-fits-all therapy is sufficient.

One relatively recent concern is HBV activation. “The reactivation of HBV appears to be temporally related to use of DAAs, and this seems to be independent of HCV genotype, type of DAA received, or [the patient’s] HCV parameters,” Dr. Brown reported, citing data from the Food and Drug Administration. “The clinical implications for this are that HBV DNA must now be monitored, so this is another level of complexity for our care providers.”

Other considerations for care of HCV despite achieving SVR with current treatments include monitoring for HCC and preventing reinfection. Dr. Brown cautioned that the risk of HCC, although greatly reduced after SVR, is not eliminated, and specific monitoring strategies are particularly important for those with fibrosis or cirrhosis prior to SVR.

In addition, the same risks for primary HCV are relevant for reinfection, according to Dr. Brown. She pointed out that these reinfection rates can be substantial in populations that persist in behaviors that result in HCV exposure.

“We are getting very close to the ideal of a one-size-fits-all treatment regimen for HCV, which would include no need to check genotype, no contraindications, no need for close monitoring, and no need to document cirrhosis, but we are not there yet,” Dr. Brown said. Even if such a regimen does emerge, she indicated that clinicians are not likely to ever be absolved from important management decisions that ensure an optimal long-term outcome.

 

PHILADELPHIA – Despite combination therapies for hepatitis C virus (HCV) that are now showing high rates of sustained viral remission (SVR) across all genotypes, a one-size-fits-all treatment will not be practical in the near future, according to a review of current and coming HCV therapies at Digestive Diseases: New Advances meeting held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

 

The focus for improving HCV care is “now shifting, I think, from this one-size-fits-all treatment to identifying, really, the one-size-fits all provider,” reported Kimberly A. Brown, MD, division head of gastroenterology/hepatology at Henry Ford Health System, Detroit.

Courtesy US. Dept of Veterans Affairs

There is no question that the most effective one-pill combinations of direct–acting antiviral (DAA) agents are simplifying treatment strategies. “Many of the special populations have dissolved into what I would now consider to be special considerations,” according to Dr. Brown. However, she cautioned that HCV management still requires skills for individualizing care.

The presence of cirrhosis in some patients demonstrates the need for this care, for example. Many of the most effective single-pill DAA combinations are demonstrating high SVR rates for HCV patients with cirrhosis, but Dr. Brown said that identification of cirrhosis prior to HCV treatment “remains imperative.” Some pangenotypic therapies require a longer duration of treatment when cirrhosis is present, and patients with cirrhosis require posttreatment monitoring for decompensation and hepatocellular carcinoma (HCC). Patients who have failed a prior anti-HCV regimen or who are in renal failure also require more individualized care.

“There is no current therapy in my opinion that allows for one combination, for one length of treatment, without consideration of any patient characteristics,” Dr. Brown said at the meeting. Although several newer combination drugs with pangenotypic properties are likely to be approved for HCV in 2017, Dr. Brown believes that the one-size-fits-all ideal is not going to be fulfilled “anytime soon.”

However, Dr. Brown does believe that HCV care can and should be shifted to trained primary care providers in order to increase the proportion of infected patients who are treated. She indicated that the pangenotypic drugs are making this easier to accomplish and cited a study from the most recent annual meeting of the American Society for the Study of Liver Diseases that showed comparable SVR rates for primary care physicians, nurse practitioners, and specialists when the primary care clinicians underwent a uniform 3-hour training program (Emmanuel B. et al. AASLD 2016;Abstract 22).

“There is an evidence basis for shifting care to primary care providers in order to expand treatment, but, certainly, these providers must have an interest,” Dr. Brown said. She also said that treatment from a primary care provider must be accompanied by follow-up care, which, for example, might include clinics specializing in alcohol or drug dependency.

In treatment-naive patients with uncomplicated HCV, nearly 100% of patients will achieve an SVR on 8-12 weeks of therapy, regardless of genotype, with the newest and most potent DAA regimens, according to data cited by Dr. Brown. However, she cautioned that, even in these patients, it would be inaccurate to conclude that one-size-fits-all therapy is sufficient.

One relatively recent concern is HBV activation. “The reactivation of HBV appears to be temporally related to use of DAAs, and this seems to be independent of HCV genotype, type of DAA received, or [the patient’s] HCV parameters,” Dr. Brown reported, citing data from the Food and Drug Administration. “The clinical implications for this are that HBV DNA must now be monitored, so this is another level of complexity for our care providers.”

Other considerations for care of HCV despite achieving SVR with current treatments include monitoring for HCC and preventing reinfection. Dr. Brown cautioned that the risk of HCC, although greatly reduced after SVR, is not eliminated, and specific monitoring strategies are particularly important for those with fibrosis or cirrhosis prior to SVR.

In addition, the same risks for primary HCV are relevant for reinfection, according to Dr. Brown. She pointed out that these reinfection rates can be substantial in populations that persist in behaviors that result in HCV exposure.

“We are getting very close to the ideal of a one-size-fits-all treatment regimen for HCV, which would include no need to check genotype, no contraindications, no need for close monitoring, and no need to document cirrhosis, but we are not there yet,” Dr. Brown said. Even if such a regimen does emerge, she indicated that clinicians are not likely to ever be absolved from important management decisions that ensure an optimal long-term outcome.

 

PHILADELPHIA – Despite combination therapies for hepatitis C virus (HCV) that are now showing high rates of sustained viral remission (SVR) across all genotypes, a one-size-fits-all treatment will not be practical in the near future, according to a review of current and coming HCV therapies at Digestive Diseases: New Advances meeting held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

 

The focus for improving HCV care is “now shifting, I think, from this one-size-fits-all treatment to identifying, really, the one-size-fits all provider,” reported Kimberly A. Brown, MD, division head of gastroenterology/hepatology at Henry Ford Health System, Detroit.

Courtesy US. Dept of Veterans Affairs

There is no question that the most effective one-pill combinations of direct–acting antiviral (DAA) agents are simplifying treatment strategies. “Many of the special populations have dissolved into what I would now consider to be special considerations,” according to Dr. Brown. However, she cautioned that HCV management still requires skills for individualizing care.

The presence of cirrhosis in some patients demonstrates the need for this care, for example. Many of the most effective single-pill DAA combinations are demonstrating high SVR rates for HCV patients with cirrhosis, but Dr. Brown said that identification of cirrhosis prior to HCV treatment “remains imperative.” Some pangenotypic therapies require a longer duration of treatment when cirrhosis is present, and patients with cirrhosis require posttreatment monitoring for decompensation and hepatocellular carcinoma (HCC). Patients who have failed a prior anti-HCV regimen or who are in renal failure also require more individualized care.

“There is no current therapy in my opinion that allows for one combination, for one length of treatment, without consideration of any patient characteristics,” Dr. Brown said at the meeting. Although several newer combination drugs with pangenotypic properties are likely to be approved for HCV in 2017, Dr. Brown believes that the one-size-fits-all ideal is not going to be fulfilled “anytime soon.”

However, Dr. Brown does believe that HCV care can and should be shifted to trained primary care providers in order to increase the proportion of infected patients who are treated. She indicated that the pangenotypic drugs are making this easier to accomplish and cited a study from the most recent annual meeting of the American Society for the Study of Liver Diseases that showed comparable SVR rates for primary care physicians, nurse practitioners, and specialists when the primary care clinicians underwent a uniform 3-hour training program (Emmanuel B. et al. AASLD 2016;Abstract 22).

“There is an evidence basis for shifting care to primary care providers in order to expand treatment, but, certainly, these providers must have an interest,” Dr. Brown said. She also said that treatment from a primary care provider must be accompanied by follow-up care, which, for example, might include clinics specializing in alcohol or drug dependency.

In treatment-naive patients with uncomplicated HCV, nearly 100% of patients will achieve an SVR on 8-12 weeks of therapy, regardless of genotype, with the newest and most potent DAA regimens, according to data cited by Dr. Brown. However, she cautioned that, even in these patients, it would be inaccurate to conclude that one-size-fits-all therapy is sufficient.

One relatively recent concern is HBV activation. “The reactivation of HBV appears to be temporally related to use of DAAs, and this seems to be independent of HCV genotype, type of DAA received, or [the patient’s] HCV parameters,” Dr. Brown reported, citing data from the Food and Drug Administration. “The clinical implications for this are that HBV DNA must now be monitored, so this is another level of complexity for our care providers.”

Other considerations for care of HCV despite achieving SVR with current treatments include monitoring for HCC and preventing reinfection. Dr. Brown cautioned that the risk of HCC, although greatly reduced after SVR, is not eliminated, and specific monitoring strategies are particularly important for those with fibrosis or cirrhosis prior to SVR.

In addition, the same risks for primary HCV are relevant for reinfection, according to Dr. Brown. She pointed out that these reinfection rates can be substantial in populations that persist in behaviors that result in HCV exposure.

“We are getting very close to the ideal of a one-size-fits-all treatment regimen for HCV, which would include no need to check genotype, no contraindications, no need for close monitoring, and no need to document cirrhosis, but we are not there yet,” Dr. Brown said. Even if such a regimen does emerge, she indicated that clinicians are not likely to ever be absolved from important management decisions that ensure an optimal long-term outcome.