Dear Editor,
IMOD, or Imona (generic name: Setarud), was first investigated in HIV-positive patients in 2006. This drug comprises a combination of herbal extracts, including Tanacetum vulgare (tansy), Rosa canina, and Urtica dioica (nettle), as well as selenium, flavonoids, and carotenoids. It exerts immunomodulatory properties and has demonstrated effects in decreasing blood sugar and cholesterol (1, 2). Setarud was patented in 2007 and has successfully undergone preclinical trials as well as phases I through IV of clinical trials. These studies established that the drug is non-genotoxic and that the maximum tolerated dose is 10 mL per day (3-7). Its safety and efficacy in HIV-positive patients were evaluated in phases II, III, and IV, where results indicated a favorable safety profile and clinically meaningful efficacy. The adverse event prevalence was approximately 1% across phases II to IV, predominantly comprising cutaneous hypersensitivity reactions, which typically resolved upon discontinuation of the drug (6, 7). Notably, the administration of IMOD led to a significant increase in CD4+ T-cell counts, which is of critical importance in preventing opportunistic infections among HIV-positive patients. The most pronounced effects were observed in a subgroup of patients with baseline CD4 counts of 200 - 400 cells/μL (6).
As IMOD is not an antiretroviral agent, it has no significant effect on plasma viral load (VL). Therefore, its administration as an adjunct to standard antiretroviral therapy (ART) may provide synergistic benefits in immune restoration and disease management. Initially, the drug was only available in injectable form for nearly a decade, which posed challenges related to treatment adherence. Subsequent clinical studies explored oral formulations, including drops and tablets; however, these formulations showed very limited efficacy, likely due to the large molecular size of the compound impeding effective absorption. Consequently, a soft-gel capsule formulation was developed and trialed, which demonstrated a statistically significant increase in CD4 counts among HIV patients. This improvement was evident both within subjects (pre- vs. post-treatment) and between treatment and control groups (8).
Additional observational findings suggest that IMOD may also be effective in treating common cutaneous warts, particularly those on the hands and feet. In some HIV-positive patients, the concurrent use of IMOD with ART resulted in the disappearance of warts, indicating potential broader immunological benefits (9). Given its immunomodulatory efficacy, low incidence of adverse effects, and oral availability in capsule form, it is recommended that IMOD (one capsule daily) be considered as a complementary therapy alongside standard ART in HIV-positive patients.
