Saturday, May 20, 2017

New Guidelines for Deprescribing Proton Pump Inhibitors

A new practice guideline aims to help clinicians make decisions about when and how to safely deprescribe proton pump inhibitors (PPIs). The evidence-based recommendations incorporate data from key clinical studies and focus on outcomes that are important to patients, including the harms and benefits of PPI dose reduction. Barbara Farrell, PharmD, ACPR, FCSHP, from the University of Ottawa in Ontario, Canada, and colleagues published the evidence-based guideline in the May issue of Canadian Family Physician. "A PPI deprescribing guideline works in conjunction with current treatment guidelines because it offers clinicians recommendations and clinical considerations to help them deprescribe PPIs in patients after an appropriate treatment duration or if long-term therapy is being reevaluated," the authors write. Concern about the overuse of PPIs has been rising as data accumulate regarding potential adverse effects, including increased risk for kidney disease, Clostridium difficile infection, and hip fractures. Chronic PPI use is also common, with some studies showing a lack of ongoing indication for PPI treatment in as many as 40% to 65% of hospitalized patients who receive the drugs. "When PPIs are inappropriately prescribed or used for too long, they can contribute to polypharmacy with its attendant risks of nonadherence, prescribing cascades, adverse reactions, medication errors, drug interactions, emergency department visits, and hospitalizations," the authors continue. Current guidelines for treating gastroesophageal reflux disease and peptic ulcer disease recommend a short course of PPIs and suggest clinicians should attempt to either discontinue these drugs or treat patients using the lowest effective dose. However, current guidelines provide no advice on how clinicians can deprescribe PPIs. Indeed, no comprehensive evidence-based recommendations have been available to help clinicians taper or discontinue PPIs, or guide them on intermittent use, step-down, or on-demand treatment strategies. According to Dr Farrell and colleagues, the new guideline is accompanied by a decision-support algorithm to address clinicians' common front-line questions about PPI deprescribing. It "provides practical recommendations for making decisions about when and how to reduce the dose of or stop PPIs," they note. During the guideline development process, review of the evidence failed to identify serious harms for PPI deprescribing in adults, the authors say. The new recommendations focus on adults older than 18 years with upper gastrointestinal symptoms who have received PPIs for a minimum of 4 weeks and have experienced symptom resolution. For these patients, the guidelines recommend clinicians should either reduce the daily dose of PPI or stop the drug and switch the patient to on-demand PPI use. The authors rate the recommendation to lower the dose of PPI or switch to on-demand use as "strong." As an alternative to using PPIs, the guidelines suggest clinicians may consider stepping down to histamine-2 receptor antagonist therapy. However, because of the greater risk for symptom return with this therapy, this recommendation is considered "weak." Although the evidence base used to develop the guideline predominantly relates to gastroesophageal reflux disease or esophagitis, the authors note that the data can be extrapolated to apply to patients with other upper gastrointestinal disorders, such as peptic ulcer disease, for which PPIs have more modest efficacy or which typically call for a short-term course of PPIs. Deprescribing is likely to be more effective in such cases, they say. Overall, the authors believe use of these new guidelines will encourage clinicians to carefully evaluate patients' continued use of PPIs, and potentially reduce polypharmacy. However, Dr Farrell and colleagues also emphasize that critical gaps in knowledge remain regarding PPI deprescribing. Future research "should address deprescribing for other PPI indications and in the frail elderly population, optimal tapering regimens or alternate treatments
to minimize symptom recurrence, consistent approaches to measuring outcomes, measurement of both positive and adverse drug withdrawal events, long-term harms and benefits, and costs," they conclude. Dr Farrell has reported receiving research funding to develop this guideline. She has reported receiving financial payments from the Institute for Healthcare Improvement and Commonwealth Fund for a deprescribing guidelines summary, and from the Ontario Long Term Care Physicians Association, the Ontario Pharmacists Association, and the Canadian Society of Hospital Pharmacists for speaking engagements. One coauthor holds a chair partially funded by AstraZeneca and has reported receiving financial payments from AstraZeneca for speaking engagements. The remaining authors have disclosed no relevant financial relationships. Can Fam Physician. 2017;63:354¬-364.

Sunday, October 23, 2016

Colonoscopy Inaccurate for Cancer Site In Nearly One-Third of Cases

The location of colon cancers determined by colonoscopy does not agree with the surgical location in almost one-third of cases, researchers have found. The problem is particularly acute for right-sided lesions, according to the study, which was presented at the 2016 Digestive Disease Week (abstract Su1623). Colonoscopy is a valuable tool not only to screen for and diagnose colorectal cancer but for localization and surveillance of tumors. The location of a tumor in the colon also guides the course of therapy with surgery, radiation or both. “Colon cancer resections are often guided by endoscopic localization,” said Jennifer Nayor, MD, of the Division of Gastroenterology, Hepatology and Endoscopy at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and co-author of the study. “Colon cancer resections are more frequently performed by a laparoscopic approach, where surgeons lose the opportunity to directly palpate the colon to ensure the correct area is being resected. If endoscopists are not accurately localizing lesions, there is the potential for flawed surgical planning and intraoperative changes to surgical procedures.” Dr. Nayor and her colleagues conducted a retrospective cohort study of patients diagnosed with colon cancer. Data were obtained on the participants’ endoscopic and surgical reports and tumor characteristics. During the study period, there were 203 cases of colon cancer and 110 cases with a colonoscopy that occurred within six months of the diagnosis. Overall, in 31% of the cases (34/110), the endoscopic location did not match the surgical location. Nearly 30% of the cases (n=10) were inaccurate by a colonic segment. For the study, colonic segments were defined as the cecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, the rectosigmoid junction and the rectum. Two cases identified by surgery as right-sided tumors were initially diagnosed as left-sided tumors by colonoscopy. Right-sided colon lesions were associated with increased risk for discordance compared with left-sided lesions, on both univariate and multivariate analyses (odds ratio, 1.83; P=0.04). “Our multicenter study showed that over 30% of colon cancers were inaccurately localized by colonoscopy compared to the gold standard of surgical localization. The only predictor of inaccurate endoscopic localization was right-sided colon cancer,” Dr. Nayor told Gastroenterology & Endoscopy News. The findings underscore the importance of using anatomic landmarks for localization during endoscopy, she added, as well as tattooing to guide intraoperative localization. “Surgeons should be aware of the issue of inaccurate endoscopic localization, so they can discuss this with patients when consenting for procedures,” she pointed out. Deborah Fisher, MD, MHS, associate professor of medicine in the Division of Gastroenterology at Duke University School of Medicine, in Durham, N.C., said with few landmarks inside the colon, estimates of location based on measurement from the anal verge may be inaccurate. “The location of the tumor can impact the surgical plan and approach,” said Dr. Fisher, who was not involved with the latest study. “A more extensive operation could result if the tumor is not near—not more than two or more segments away from—the expected location.” Location is particularly important for rectal or rectosigmoid tumors, she added. Dr. Fisher noted that the cases of right-sided lesions mistaken for left-sided ones are the “most concerning” finding in the study. The results support the use of confirmation of cecal location with cecal intubation to help avoid mistaking a right-sided lesion for a left-sided one and the use of tattoo marking of the tumor, she said.

Tuesday, July 12, 2016

HCV Infection Eradication in Cirrhosis With and Without Portal Hypertension

Atif Zaman, MD, MPH reviewing Di Marco V et al. Gastroenterology 2016 Jul. Successful treatment was associated with reduced risks for liver complications, hepatocellular carcinoma, and death, but not progression of portal hypertension. Hepatitis C virus (HCV) infection eradication in patients with cirrhosis may change the course of liver disease outcomes. Few data exist regarding the effect of HCV infection eradication on portal hypertension in this population. In a prospective cohort study performed at a single tertiary care center in Italy, researchers assessed liver-related outcomes including ascites, variceal hemorrhage, encephalopathy, hepatocellular carcinoma, and deaths in 444 patients with compensated, HCV-related cirrhosis with or without small esophageal varices. Patients underwent treatment with peginterferon and ribavirin for 48 weeks. During endoscopic screening and surveillance, the development of new varices and progression of varices were assessed. During a median follow-up of 7.6 years, the following results were observed: Sustained virologic response (SVR) at 24 weeks posttherapy was achieved in 31% of patients without varices and 18% of those with varices. Among patients without varices, achieving SVR was significantly associated with lower likelihood of developing varices (hazard ratio, 0.2). Among patients with varices, achieving SVR was not significantly associated with reduced risk for progression of varices. Regardless of whether patients had varices, achieving SVR was associated with reduced risks for liver disease complications (e.g., ascites), hepatocellular carcinoma, and mortality.

Sunday, May 29, 2016

Half at Night and Half in the Morning—a Better Way To Prepare for Colonoscopies

Gastroenterologists and other physicians are virtually unanimous in appreciating the vital importance of colonoscopy screenings. In preparation for colonoscopies, we direct patients to drink a large volume of bowel-cleansing liquid, usually in one day. Past studies have shown that splitting this dose—drinking half the night before and half in the morning before the procedure—leads to better bowel cleansing compared with drinking the entire dose the night before. Yet barriers still remain to the acceptance of split dosing, including the perceived patient inconvenience of consuming two separate doses. My colleagues and I wanted to learn whether the split-dose preparation is more convenient for patients, and whether it would lead to finding more precancerous polyps. Split dosing is already recommended by the U.S. Multi-Society Task-Force on Colorectal Cancer, and our study provides additional support for its benefits by demonstrating that it decreases total bowel prep ingestion time, reduces the intensity and duration of bowel movements, and is associated with less sleep disruption. The results were clear to us in confirming the superior performance of the split dose, not only in overall bowel cleansing, but in detecting dangerous polyps. Our team, including Carol Burke, MD, found that endoscopists reported “excellent” or “good” cleansing in 95.6% of the split-dose group, a full 10 percentage points above the single-dose group, which achieved those ratings in only 85.5% of cases. The split-dose method also resulted in a higher overall rate of finding polyps and adenomas. However, the most dramatic difference was specifically seen in detecting another serious and potentially life-threatening condition—the presence of sessile serrated polyps (SSPs). In screening patients from both groups, the physicians found SSPs at a rate four times higher in the split-dose group than in the single-dose group (9.9% vs. 2.4%). We regard our results as additional evidence for practitioners to confidently adopt split dosing as a standard procedure. For patients who aren’t given this option, we recommend they ask their GI about it. The improved ability to detect SSPs is too significant a benefit to overlook in our continuing effort to eliminate colorectal cancer. Nicholas Horton, MD, is a PGY-2 resident in internal medicine at the Cleveland Clinic. He completed medical school at the Wright State University Boonshoft School of Medicine, in Dayton, Ohio. He plans to pursue a fellowship in gastroenterology, and has a particular academic interest in colorectal cancer prevention and inflammatory bowel disease. Dr. Horton presented data from this study, “Sessile Serrated Polyps Are Detected More Often With Split Versus Single Dose Low Volume Bowel Preparation: Results From a Prospective Trial,” at the 2016 Digestive Disease Week (abstract Su1663). The study received outside funding from Salix Pharmaceuticals.

Brief Talk Gets Patients in Control of Reflux

Ninety seconds of education appeared to work wonders in getting heartburn patients to optimize their use of the proton pump inhibitor omeprazole, researchers reported here at the annual Digestive Disease Week conference. Patients who were given instruction in the medicine's use by their doctor had a mean 4-point drop in Gastroesophageal Reflux Disease Symptom Assessment Scale Mean Symptom Score after 6 weeks compared with just minor change among patients who were not given the educational talk (P<0.01), said Abhijeet Waghray, MD, of MetroHealth System/Case Western Reserve University in Cleveland. Similarly, significant declines in symptom frequency and symptom severity were seen among those patients who had the intervention, Waghray said at his poster presentation. And what was the intervention that produced these results? Patients were told they they had to take their medication 15 to 30 minutes before their first meal of the day in order for omeprazole to be effective. "It takes about 90 seconds to deliver the message and answer any questions," he told MedPage Today. In so-called OSCAR (Omeprazole Dosing and Symptom Control -- A Randomized Controlled Trial), 29 patients were given the quick educational lesson when they came to the office and complained that their treatment wasn't effective; 35 other patients were controls -- they where not provided with emphasis on how to take their medicine, but rather were essentially waitlisted to receive the talk a few weeks later. In the meantime, they were encouraged simply to keep taking omeprazole. Patients were eligible for the study if their experienced heartburn three or more times a week despite treatment with 20 mg omeprazole. They were observed for 2 weeks on the current regimen and then were randomized to received the pep talk on optimal dosing time or were left to continue their medication as they were taking it. Their dose was not changed, although people who were on different doses were not included in the study, Waghray said, to reduce the variables in conducting the research. Four weeks later their symptoms were analyzed. Those given the added instruction achieved an overall significant decrease in symptoms, reflected in reductions in both symptom severity and symptom frequency, Waghray said. After the 6-week trial, the patients who were not given instruction in the first round were provided the educational talk. Symptom assessment at 4 weeks showed reductions similar to those achieved in the first intervention group. About 40% of the patients in the study were men; about 37.5% were Caucasian and 48.4% were African. More than 40% of the patient population had attended college or were college graduates or had done post-graduate studies. Waghray said there were no statistically significant differences between the groups' demographics. "Proper education and proton pump inhibitor dosing should serve to reduce the burden of persistent GERD symptoms and related costs of uncontrolled disease," Waghray said. William Ravich, MD, of Johns Hopkins University, told MedPage Today, "It is absolutely true that people come in and are not taking their medication at the appropriate time. This has been the standard time for taking these drugs since they were introduced decades ago. Either doctors don't pay enough attention to educating the patient or the patient ignores it. "It is very difficult to take medication a half hour before breakfast," said Ravich, who was not involved with the study. "I have trouble taking medicine on any regular schedules. So I think this has to be reinforced, and I think this study justifies the original recommendations for taking the drugs."

Hospitals Struggle to Keep Endoscopy Safe

Hospitals are taking the problem of gastrointestinal endoscope reprocessing seriously, reports here at Digestive Disease Week suggested, to the point of spending hundreds of thousands of dollars in order to meet recent FDA guidelines. Reports last year that dozens of patients had been sickened -- some fatally -- by multidrug-resistant infections they acquired from incompletely sterilized duodenoscopes and other endoscopy instruments have prompted an industry-wide effort to do a better job of cleaning the equipment after use. In August, after it was revealed that the manufacturers had received numerous reports of carbapenem-resistant enterobacterial (CRE) infections over a multiyear period without doing anything about them, the agency issued new guidelines that called on endoscopy centers to rigorously follow manufacturers' instructions for reprocessing and to perform "microbiological culturing on a regular basis" to check on the devices' sterility after cleaning. "Every center that does endoscopy is looking at the quality of their reprocessing and putting in a surveillance program," said John Vargo, MD, MPH, of the Cleveland Clinic, at a DDW press briefing. However, as gastroenterology fellow Ji Young Bang, MD, of Indiana University in Indianapolis, told MedPage Today, the guidelines did not specify how often the culturing should be performed and on what percentage of scopes at any given time. As a result, centers have had to decide for themselves how to follow the letter and spirit of the guidelines without going broke. In many cases, endoscopists are going beyond the manufacturers' recommended reprocessing steps to add their own extra procedures. At Maine Medical Center in Portland, for example, the hospital's Pancreaticobiliary Center has been applying an alcohol "flush and flex" protocol prior to each use -- this in addition to the standard post-use processing. At DDW, Matthew Warndorf, MD, and colleagues reported that they had experienced no endoscope-associated infections after instituting the protocol in mid-2015, during which nearly 1,800 endoscopies involving elevator-equipped instruments were performed. Bang's center simply doubled up on the manufacturers' instructions, performing the entire process twice for every instrument after use. But at both centers, and others that reported culture findings here, none of the beefed-up protocols was 100% effective at sterilizing all scopes every time. Bang, for example, said that 592 culture studies performed on 62 different scopes revealed 59 instances of residual contamination. Although 54 of these were benign organisms, that still left five with pathogenic organisms identified, including three involving enterococci. All of these were found from swabs of the elevator mechanism, a moving part at the endoscope tip that allows the operator to change the working angle of some accessory that appears to be the crux of the contamination problem. "The design of the scopes make it difficult to clean them," said Grace Elta, MD, DDW council chair and a gastroenterologist at the University of Michigan. An FDA advisory panel last year agreed that the current generation of duodenoscopes are all unsafe, but also irreplaceable and therefore must continue to be used. The panel's recommendations on more rigorous adherence to sterilization procedures were largely reflected in the August guidance. Manufacturers' instructions generally call for the endoscope and elevator to be scrubbed with a special brush before liquid and/or gaseous sterilizers are applied. But the elevator mechanism is hinged and has other tiny crevices that appear capable of defeating all mechanical and chemical cleaners. However, said Elta, "historically the endoscope infections have related to human error. ... What most centers are doing is doing their best to eliminate that human error." This can be costly. Bang said that, because the culturing procedure means that a scope must be removed from service until it is certified contaminant-free, her center had to buy 40 new scopes in order to maintain procedure volume, at approximately $10,000 apiece. Douglas Faigel, MD, and colleagues at the Mayo Clinic in Scottsdale, Ariz., reported that they had to buy five new scopes with a list price of $223,000, and three of the unit's instruments ended up with "critical damage" from ethylene oxide gas sterilization. Meanwhile, University of Pennsylvania researchers reported that the direct costs of the culturing program amounted to a little more than $21,000 per year, although that was just for 19 duodenoscopes, each of which was cultured monthly. They did not say anything about new equipment. As for more definitive solutions, everyone asked by MedPage Today said the scope designs need to be made simpler and crevice-free. Vargo said he thought that scopes that need elevator mechanisms would eventually come with "a detachable tip that will allow cleaning." Other approaches might include removable sheaths that keep bacteria from lodging in the scope tip in the first place. An affordable single-use device would be another possibility. Manufacturers haven't publicly reported any such developments yet, Vargo said, but "I suspect in the next couple years we will see some."

Thursday, March 10, 2016

Oral recombinant H. pylori vaccine

In a randomized phase 3 trial, 4464 H. pylori uninfected children (ages 6 to 15 years) were assigned to a three-dose oral recombinant H. pylori vaccine or placebo]. At one year, the incidence of H. pylori infection was significantly lower in the vaccine group. Among patients who completed extended follow-up, H. pylori acquisition continued to be lower in vaccinated as compared with unvaccinated children, but protection levels were lower in the second and third year. There were no serious adverse events related to the vaccine. Additional studies with long-term follow-up are needed to validate these results

Skin disorders associated with TNF inhibitor use

A variety of skin disorders have been reported in association with the use of tumor necrosis factor (TNF) inhibitors for inflammatory and autoimmune conditions. The largest of several recent studies of patients with inflammatory bowel disease (IBD) receiving these agents involved a cohort of 917 consecutive patients with IBD on TNF inhibitors for a median of 3.5 years, in whom 29 percent developed skin lesions (12.4 per 100 patient-years) . Specific cutaneous lesions included (from most to least common) psoriasiform eczema, eczema, xerosis cutis, palmoplantar pustulosis, and psoriasis; other abnormalities were mostly infectious and inflammatory skin lesions and alopecia. The majority of patients were managed without discontinuation of TNF inhibitor therapy. Limitations of the analysis included uncertainty regarding the relative roles of the treatment and the underlying disease due to the lack of a matched control group not receiving TNF inhibitors

Olmesartan enteropathy

Olmesartan, an angiotensin receptor blocker (ARB), can produce a "sprue-like enteropathy" characterized by severe chronic diarrhea and weight loss, occurring months to years after initiation of the drug. The largest experience comes from a French cohort of over 4 million patients who initiated therapy with olmesartan, a different ARB, or an angiotensin converting enzyme (ACE) inhibitor . Compared with users of ACE inhibitors, intestinal malabsorption severe enough to cause hospitalization occurred substantially more often among patients taking olmesartan for one to two years (adjusted risk ratio 3.7) and among those taking olmesartan for more than two years (adjusted risk ratio 10.6). Risk was not increased in users of other ARBs. Although a large number of patients (ie, 12,550) needed to be treated with olmesartan for two or more years to produce one additional case of enteropathy requiring hospitalization, less severe but still clinically significant cases of enteropathy may have been more frequent. Patients starting olmesartan should be cautioned about the possibility of developing diarrhea and weight loss. The drug should be stopped if these symptoms occur and another cause is not identified.

Sigmoid resection versus laparoscopic lavage for perforated diverticulitis

The laparoscopic lavage and drainage procedure was introduced as a potentially less morbid alternative to sigmoid resection for patients with perforated diverticulitis. In the SCANDIV trial, 199 patients with perforated diverticulitis were randomized to undergo either laparoscopic lavage or sigmoid resection . At 90 days, laparoscopic lavage did not improve mortality rates (14 versus 12 percent) or major morbidity rates (31 versus 26 percent) compared with sigmoid resection. Furthermore, patients who underwent laparoscopic lavage were more likely to require reoperation (20 versus 6 percent) for complications such as secondary peritonitis or missed sigmoid cancer. Based upon these results and other available data, sigmoid resection with or without fecal diversion remains the preferred intervention for patients with perforated diverticulitis.

Sunday, February 07, 2016

Office Visits Prior to Screening Colonoscopy Add to Medical Costs

Office visits prior to screening colonoscopy add to medical costs, and it's unclear whether those visits are necessary, researchers report. "Going into the project, I was expecting there to be more precolonoscopy office visits than we found," Dr. Kevin R. Riggs, from Johns Hopkins University School of Medicine, Baltimore, told Reuters Health by email. "It seems that not having a precolonoscopy office visit (open-access colonoscopy) really is the norm." Open-access colonoscopy began in the 1990s, but how widespread it is has been unclear. Dr. Riggs's team used data from MarketScan Commercial Claims and Encounters to determine the proportion of colonoscopies for colon cancer screening and polyp surveillance that were preceded by office visits and the payments associated with those visits. Among 842,849 patients who underwent colonoscopy between 2010 and 2013, 29.4% had a precolonoscopy visit, according to the February 2 JAMA online report. Among patients with office visits, two-thirds (66.4%) had no significant medical conditions, with a Charlson Comorbidity Index (CCI) of 0, but patients with office visits did have higher CCI than those without office visits. Distributed across all patients, the precolonoscopy office visits added a mean of $36.37 per colonoscopy. While this amount seems modest, it amounts to significant cumulative costs when considering the estimated 7 million screening colonoscopies performed annually in the U.S., the authors point out. The researchers were unable to determine the exact circumstances of these office visits, and they could not determine whether the visits were necessary or appropriate. "Colonoscopy is generally a very safe procedure, and it is unlikely that an office visit with the gastroenterologist beforehand makes it any safer," Dr. Riggs said. "It's possible that the office visit is an opportunity to identify patients who should not undergo colonoscopy because the risk is too high, but that is relative and depends on how much benefit can be expected." "In general, the appropriateness for colonoscopy can be made by primary care doctors, and most patients for whom colon cancer screening is recommended by practice guidelines probably don't benefit from an extra precolonoscopy office visit," he said. "Obviously, if patients don't have a primary care doctor and haven't seen a doctor recently, it's probably a good idea to get checked out before any procedure." "Open-access colonoscopy for colon cancer screening is the norm," Dr. Riggs concluded. "If gastroenterologists aren't offering it, or if primary care doctors are routinely referring their patients for whom they have decided colonoscopy is indicated for evaluation before the colonoscopy, they should consider changing their practice. Not only do these office visits waste potentially hundreds of millions of dollars annually, but requiring unnecessary office visits makes for a less pleasant patient experience." Dr. John I. Allen, clinical chief of digestive diseases at Yale University, New Haven, Connecticut, told Reuters Health by email, "I have worked for 25 years within a large private single specialty (gastrointestinal) group where 85% of endoscopy was open access and 15% was generated after a clinic visit with us. This not only saved money, but freed up clinic to see more needy patients. The no-show rate for endoscopy was 1%." "I now work at Yale - mostly a Medicaid, Marketplace, or Medicare population - where our no-show rate is >20%. Pre-endoscopy visits would be a great addition, but we are so understaffed that it would be impossible," he said. "Open access saves money and is appropriate for a population that complies with recommendations (can follow the complex process of preparation) and will show up for their appointment," Dr. Allen concluded. "Precolonoscopy visits can help prevent canceled procedures due to poor prep (up to 15% of procedures in some populations), identify patients needing more intense care, and in some cases help patients be comfortable with undergoing an invasive procedure." The National Institutes of Health supports two coauthors. One coauthor owns stock in the Advisory Board Company. JAMA 2016

Monday, November 02, 2015

HCV Guideline Update: Treat All Patients With New Drugs

The American Association for the Study for Liver Diseases and the Infectious Disease Society of America (IDSA) have updated HCVguidelines.org so that it reflects the current understanding that virtually all individuals who are positive for the hepatitis C virus (HCV) should receive the newer HCV treatment. The site emphasizes that new sections have been added and that the recommendations are updated regularly as new information becomes available. The guidelines begin by explaining that new direct-acting oral agents that can cure HCV infection have been approved in the United States. "We've been accumulating understanding of the value and safety of the medications," David L. Thomas, MD, MPH, spokesperson for IDSA, explained to Medscape Medical News. He described the change in position as an "evolution." When the newer HCV drugs were first introduced, physicians had to rely entirely on data from clinical trials. The new guidelines reflect the addition of real-world physician experience. The new guidance explains that the sustained virologic response that is characteristic of a successful HCV treatment would benefit almost everyone who is infected with HCV. Moreover, many of the highest-risk patients have already had the opportunity to receive treatment with the new medications. The IDSA notes that the cost of the new drugs and regional availability of the appropriate healthcare provider may still translate into a need to prioritize patients for treatment. Some general practitioners will feel comfortable treating their HCV-positive patients, and others will feel more comfortable referring their patients to a specialist for treatment. "A good relationship between physician and patient is crucial to achieving the best outcomes with direct-acting therapies. The physician needs to make an assessment of a patient's understanding of the treatment goals and provide education on the importance of adherence to the therapy and follow-up care," said IDSA panel cochair Gary Davis, MD, in a press release. Dr Thomas said that although the guidelines are meant to demystify treatment, the most severely affected patients should probably be referred to a specialist. "For hepatitis C, the patients who are often in need of referral are those with severe liver disease and cirrhosis," he explained. Unfortunately, it is hard for physicians to predict reimbursement from insurance companies. "Our focus is on the physicians and the patients," explained Dr Thomas, calling the world of insurance companies "challenging" and "vexing." According to HCVguidelines.org, approximately 3 to 4 million individuals in the United States are chronically infected with HCV, and half of them are unaware of their status.