ObjectiveInfections and other stressors have been implicated in the development of fibromyalgia. We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. This study evaluated a famciclovir + celecoxib drug combination (IMC-1), active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia.MethodsA total of 143 fibromyalgia patients were enrolled at 12 sites in a 16-week, double-blinded, placebo-controlled proof-of-concept trial. Randomized patients received either IMC-1 or placebo in a 1:1 ratio. Outcome measures included a 24-hour recall pain Numerical Rating Scale, the Revised Fibromyalgia Impact Questionnaire (FIQ-R), the Patient’s Global Impression of Change (PGIC) questionnaire, the Multidimensional Fatigue Inventory, the NIH Patient-Reported Outcomes Measurement Information System (PROMIS), and the Beck Depression Inventory-II conducted at baseline and weeks 6, 12, and 16 of the study.ResultsA significant decrease in fibromyalgia-related pain was observed for patients on IMC-1 treatment versus placebo. PGIC response rates were significantly improved with IMC-1 treatment. Overall, patient self-reported functioning, as measured by the FIQ-R, was significantly improved. Fatigue was also significantly improved as measured by the PROMIS fatigue inventory. The safety profile was encouraging. Despite the celecoxib component of IMC-1, gastrointestinal and nervous system treatment emergent adverse events were reported less frequently in the IMC-1 group, and study completion rates favored IMC-1 treatment.ConclusionIMC-1 was efficacious and safe in treating symptoms of fibromyalgia, supporting the hypothesis that herpes virus infections may contribute to this syndrome. Improved retention rates, decreased adverse event rates, and evidence of efficacy on a broad spectrum of outcome measures are suggestive that IMC-1 may represent an effective, novel treatment for fibromyalgia.

A training technique for posterior truncal vagotomy and an anterior seromyotomy in the anesthetized pig is described. The first of five procedures was performed open in a conventional method. All succeeding procedures were performed after the establishment of a pneumoperitoneum with CO2 insufflation and the placement of two 10 mm trocars and three 5-mm trocars. A 45 degree camera and monopolar electrocautery were used during the video laparoscopic procedure. After completion of the procedure, the pigs were opened to closely inspect the surgery performed. Though there are some minor anatomic differences between porcine and human anatomy, the pig is an excellent model for gaining technical experience in the performance of a posterior truncal vagotomy and anterior seromyotomy.

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Purpose Animal studies have linked gastric herpesvirus infections to symptoms associated with functional gastrointestinal disorders (FGIDs). Herpesviruses have also been hypothesized to contribute to fibromyalgia (FM), a chronic pain syndrome frequently comorbid with FGIDs. The purpose of this study was to compare the prevalence of gastric herpesvirus infection in patients with FGIDs, with and without comorbid FM, to that of controls. Methods For this pilot case–control study, we enrolled 30 patients who met both the Rome IV diagnostic criteria for one or more FGIDs and the American College of Rheumatology 2010 criteria for FM, 15 patients with one or more FGIDs without comorbid FM, and 15 control patients. Following endoscopic examination, gastric biopsies were analyzed for herpesvirus DNA and protein, Helicobacter pylori infection, and histological evidence of gastritis. Importantly, the viral nonstructural protein ICP8 was used as a marker to differentiate cell-associated actively replicating virus from latent infection and/or free virus passing through the GI tract. Results Gastric herpes simplex virus type 1 (HSV-1) infection, as indicated by ICP8 presence, was significantly associated with FGIDs in the presence (OR 70.00, 95% CI 7.42–660.50; P < .001) and absence (OR 38.50, 95% CI 3.75–395.40; P < .001) of comorbid FM. Neither histological gastritis nor H. pylori infection were found to be associated with FGIDs or FM. Conclusions HSV-1 infection was identified in gastric mucosal biopsies from patients with diverse FGIDs, with and without comorbid FM. Larger, multi-center studies investigating the prevalence of this association are warranted.

Background:Fibromyalgia is a chronic disease characterized by widespread pain and severe fatigue that may be triggered by reactivation of latent herpes simplex virus type 1 (HSV-1). In a Phase 2a proof of concept trial, IMC-1 (a fixed dose combination of famciclovir and celecoxib) demonstrated greater tolerability and statistically significant reduction in pain compared with placebo, as measured by change from baseline to week 16 in 24-hour recall pain intensity on an 11-point Numerical Rating Scale (NRS) and 7-day recall pain intensity on the 11-point pain item on the Revised Fibromyalgia Impact Questionnaire (FIQ-R).Objectives:In this post hoc analysis, we evaluated the effects of IMC-1 compared with placebo on other fibromyalgia symptoms, including lack of energy, stiffness, problems with sleep, problems with memory, depression, and anxiety.Methods:In the double-blind, multi-center, placebo-controlled trial, male or female patients 18–70 years of age who met diagnostic criteria for fibromyalgia and had at baseline a 24-hour recall average pain intensity score between 4 and 9 on the NRS were randomized 1:1 to 16 weeks of treatment with IMC-1 or placebo. Mean changes from baseline to week 16 in FIQ-R symptom scores were analyzed using a Mixed-Effect Model Repeated Measure (MMRM) model with treatment as the main effect, and investigative site and baseline FIQ-R symptom scores as covariates.Results:A total of 143 patients were enrolled and randomized to treatment with IMC-1 (n=69) or placebo (n=74). Baseline demographic and clinical characteristics were comparable between treatment groups; the majority of patients were Caucasian (95.8%) and female (93.7%) with a mean age of ~49 years. Compared with placebo, treatment with IMC-1 resulted in statistically significant improvements in the FIQ-R symptom scores of stiffness (least squares mean change from baseline -0.96 vs. -1.92, P=0.03), sleep quality (-0.76 vs. -1.76, P=0.039), depression (-0.44 vs. -1.33, P=0.016), and anxiety (-0.30 vs. -1.69, P<0.001), but not in energy level (-0.67 vs. -1.29, P=0.115) or memory problems (-0.71 vs. -1.24, P=0.165).Conclusion:In addition to alleviation of chronic pain, treatment with IMC-1 appears to be effective in improving many of the other symptoms often associated with fibromyalgia. Further clinical trials are warranted.References:[1]Pridgen WL, Duffy C, Gendreau JF, Gendreau RM. A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia. J Pain Res. 2017;10:451-460.Disclosure of Interests:William Pridgen Consultant of: Virios Therapeutics, Carol Duffy Consultant of: Virios Therapeutics, Grant/research support from: The University of Alabama, Department of Biological Sciences has received financial research support from Innovative Med Concepts (now Virios Therapeutics) in the form of two Sponsored Research Agreements., Judy F. Gendreau Consultant of: Tonix, Dare Bioscience, Virios Therapeutics, R. Michael Gendreau Consultant of: Tonix, Teva, Swing Therapeutics, Dare Bioscience, Employee of: Virios Therapeutics.