A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia

Abstract

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.

Corroboration of a Major Role for Herpes Simplex Virus Type 1 in Alzheimer’s Disease

“…Tzeng et al ( 2018b ) described several possible limitations, and therefore concluded that the findings suggest association of FM with dementia, rather than causation, and that a longer follow-up period would help to clarify the long-term risks. However, in view of the study by Pridgen et al ( 2017 ) suggesting that herpes virus infections may contribute to FM, the linking factor—and probable causative agent—is HSV1.…”

“…FM is characterized by chronic widespread pain, fatigue, sleep disruption, and cognitive impairment. Pridgen et al ( 2017 ) treated patients with the antiherpetic famciclovir (FCV), a nucleoside analog, in combination with a Cox-2 inhibitor, celecoxib (combination referred to as IMC-1), in a multicenter trial. Usage of the anti-herpes antiviral agent was based on the hypothesis that the disorder is caused by intermittent reactivation of latent HSV1 because of stress, etc.…”

T Cell Subpopulations in the Physiopathology of Fibromyalgia: Evidence and Perspectives

“…According to this view, both trauma and infection, which are common triggering events of autoimmunity, can also precede the onset of fibromyalgia [77]. The authors refer to data indicating that various pathogens such as Epstein-Barr virus, herpes simplex virus, known as risk factors for autoimmune diseases, are also involved in the etiology of fibromyalgia [77,78]. It has been reported that in some cases, fibromyalgia can be temporally associated with autoimmune syndrome induced by adjuvants and, similarly to other autoimmune diseases, it has a female predominance [79,80].…”

Pharmaceutical Interventions in Chronic Fatigue Syndrome: A Literature-based Commentary

“…On the other hand, the subclass of NSAIDs consisting of COX-2especific inhibitors are of potential interest in treating ME/CFS because it has been demonstrated that COX-2 plays a central role in the replication of viruses and is up-regulated during viral infection. 28,29 If ME/CFS does in fact have a viral origin, selective COX-2 inhibitors may be useful in treating latent infections. Selective COX-2 inhibitors, such as celecoxib, have been demonstrated to be effective in the treatment of fibromyalgia.…”

“…Selective COX-2 inhibitors, such as celecoxib, have been demonstrated to be effective in the treatment of fibromyalgia. 29 Although fibromyalgia is believed to be a distinct condition, symptoms often overlap with those of ME/CFS. 30 If further research demonstrates a link between the etiologies of the 2 conditions, there may be cause for the use of drugs such as celecoxib in a subset of patients with ME/CFS.…”