Combination Therapy for HCV Assessed

48 Gastroenterology I NTERNAL M EDICINE N EWS • July 1, 2006 Watch for Signs Combination Therapy for HCV Assessed Of Gastric BY MARY ELLEN SCHNEIDER ducted by researchers from the Universi- terferon combinations in 81 patients who Senior Writer ty of Tübingen in Germany, showed that had experienced a previous relapse after Lymphoma at the end of 72 weeks of daily therapy, a standard 48 weeks of pegylated inter- L OS A NGELES — Extended combina- the majority of patients treated with a feron plus ribavirin. At the end of week BY DOUG BRUNK tion therapy with consensus interferon combination of either consensus inter- 72, 89% of patients taking the consensus San Diego Bureau for 72 weeks appears to help improve the feron plus ribavirin or pegylated inter- interferon combination were in remis- viral response of patients with chronic feron alfa-2a plus ribavirin had a reduc- sion, compared with 76% of the pegy- L OS A NGELES — Have a high index of hepatitis C virus who have previously re- tion in hepatitis RNA. However, the drop lated alfa-2a interferon group. suspicion for gastric lymphoma in a pa- lapsed after a 48-week course of treat- was not statistically significant, said the But relapse rates remained high in the tient who presents with severe abdominal ment, according to a study presented at lead study author, Dr. Stephan Kaiser, a study, Dr. Kaiser said. The pegylated alfa- pain, weight loss, and melena, Dr. Ijeoma the annual Digestive Disease Week. professor of medicine at the university. 2a interferon combination led to signifi- A. Azodo advised in a poster session at the The investigator-initiated study, con- The investigators compared the two in- cantly higher rates of relapse than the annual Digestive Disease Week. “They will have other symptoms, such as early satiety, heartburn, and things that would warrant upper endoscopy,” Dr. Azodo of the Mayo Clinic in Rochester, Minn., said in an interview. She based her comments on results from an analysis of 711 hospitals participating in the gastric Looking closer at patients with some acid-related disorders Symptoms include severe abdominal pain, weight loss, may reveal individual needs. melena, early satiety, and heartburn.

DR. AZODO cancer patient care evaluation study of the National Cancer Data Base, which is an al- liance between the American College of Surgeons’ Committee on Cancer and the American Cancer Society. The analysis was limited to clinical data on the management of patients with gastric cancer collected between January 2001 and December 2001. Of the 7,084 gastric malignancies in 2001, 688 (10%) were lym- phomas. Patients with gastric lymphoma were predominantly white (73%), and more than half (57%) were male. The I w mean age at diagnosis was 69 years, and the I need I need a cho three most common symptoms at presen- something prescription tation were severe abdominal pain (74%), weight loss (61%), and melena (47%). that that’s my m Upper endoscopy with tissue biopsy works. covered. was used in 86% of cases, and the proce- dure identified a gastric lymphoma in nearly all (97%). Abdominal and pelvic CT scans were also used for staging purposes, I’m concerned but newer technologies such as endo- about cost. scopic ultrasonography and laparoscopy were infrequently used. Dr. Azodo also reported that the most common gastric lymphoma sites were un- specified/diffuse/multiple (50%) and dis- tal (16%), and that 31% of patients had a history of Helicobacter pylori infection while 22% had negative test results. Large-cell diffuse lymphoma was present in 49% of patients, and marginal zone B-cell lymphoma was present in 36%. Fewer than half of all gastric lymphoma patients with H. pylori exposure received PREVACID HELPS GERD PREVACID SOLUTAB an adequate regimen of therapy for its PATIENTS FIND HEARTBURN PREVACID IS (LANSOPRAZOLE) ORALLY eradication. RELIEF (UP TO 8 WEEKS).1 COVERED ON 85%* OF DISINTEGRATING TABLETS F Most patients (89%) were treated with- MANAGED ARE THE LOWEST PRICED AD PREVACID HELPS HEAL out surgery, but those who underwent CARE PLANS.†2 BRANDED RX PPI.‡2 surgery had a 30-day mortality of 19%. ESOPHAGEAL EROSIONS Postsurgical adjuvant therapy was used in (UP TO 8 WEEKS).1 5% of patients. Radiation was the stand- alone treatment in 9% of patients, and chemotherapy was administered in 51% of patients. ■ July 1, 2006 • www.internalmedicinenews.com Gastroenterology 49

consensus interferon combination. About opicitabine (NM283) at high doses plus pe- terferon plus ribavirin as a control. and nausea at initiation of treatment, and 44% of the patients in the pegylated alfa- gylated interferon can reduce hepatitis Valopicitabine, manufactured by Idenix three patients were hospitalized with de- 2a interferon combination group had a RNA at 24 weeks of treatment, reported Pharmaceuticals, is the first nucleotide- hydration, so researchers stopped using sustained viral response after completing Dr. Paul Pockros type HCV poly- the 800-mg dose and are continuing with treatment, compared with 69% of those in of Scripps Clinic In patients who had relapsed, merase inhibitor 200-mg and 400-mg doses of the drug. the consensus interferon group. in California and 89% of those on the consensus to advance to The results with the combination of Overall, the study indicated that treat- his colleagues. phase II trials. 400 mg of valopicitabine and pegylated in- ment for relapse can be successful using The five-arm interferon combination were in The study is terferon were less promising in the non- consensus therapy for an extended period, study is compar- remission, compared with 76% funded by the responder study population, with about a but more research is needed in multicen- ing valopicita- drug maker. 2.5-log decrease, Dr. Pockros said. ter trials, Dr. Kaiser said. bine alone with on pegylated alfa-2a interferon. The best re- Continued treatment is needed to find Researchers also presented new data on three different sults—about a 3- out if there will be a sustained response treatments for another difficult-to-treat doses of valopicitabine (400 mg/day, 800 log decrease in hepatitis RNA—were with the new drug combination, Dr. Pock- population: nonresponders. Interim re- mg/day, and dose-ramping from 400 to achieved with the 800-mg dose of valop- ros said, and to find out if the drug will be sults from an ongoing phase II multicen- 800 mg/day) in combination with pegy- icitabine plus pegylated interferon. How- more effective for preventing relapse than ter trial show that a combination of val- lated interferon, and with pegylated in- ever, some patients experienced vomiting are current therapies. ■

Important safety and other information • Adverse events reported most frequently for PREVACID were diarrhea (3.8%), abdominal pain (2.1%), and nausea (1.3%). • Symptomatic response to therapy does not preclude the presence of gastric malignancy. PREVACID formulations are contraindicated in patients with known hypersensitivity to any component of the formulation. • PREVACID products should not be crushed or chewed. • Individual results may vary. • Cost comparisons do not imply any information regarding safety or efﬁ cacy. See adjacent page for brief summary of prescribing information.

I want to *Excludes PBMs, employers groups, and state Medicaid. choose how † Based on Formulary Compass™ managed care database available through MediMedia Information Technologies, December 28, 2005. I take At least one PREVACID product is covered. my medicine. ‡ Based on WAC (Wholesale Acquisition Cost) pricing per oral tablet/ capsule published by First DataBank, Inc., April 2006. WAC is a published price list; actual cost to pharmacy or consumer may differ. Phenylketonurics: PREVACID SoluTab contains phenylalanine 2.5 mg d per 15 mg tablet and 5.1 mg per 30 mg tablet.

References 1. PREVACID Complete Prescribing Information. 2. Data on ﬁ le, TAP Pharmaceutical Products Inc. 3. PREVACID I.V. Complete Prescribing Information. 4. PREVPAC Complete Prescribing Information. 5. PREVACID NapraPAC Complete Prescribing Information.

LLY PREVACID HAS ETS FORMULATIONS THAT MAY ED ADDRESS A BROAD RANGE OF PATIENT NEEDS.1,3-5