Tecovirimat is well tolerated and associated with the rapid alleviation of rectal pain among patients with severe proctitis secondary to monkeypox virus, according to case report findings published in Annals of Internal Medicine.
In this case report, the study authors described the effects of oral tecovirimat for the treatment of monkeypox virus-associated severe proctitis in 2 men, both of whom were receiving HIV pre-exposure prophylaxis at the time of diagnosis.
Current guidance from the Centers for Disease Control and Prevention (CDC) recommends that clinicians consider tecovirimat for patients with severe monkeypox and those at increased risk for progression to severe disease.
Presentation and Examination
Patient 1 was 26 years of age at the time of diagnosis. The patient presented with rectal pain and clear discharge 6 days following receptive anal intercourse. Initial symptoms included bilateral inguinal pain with lymphadenopathy, bilateral eye pain and erythema, and fever. On day 4, the patient’s fever subsided. At this time, new pruritic lesions were noted in his mouth and over his face and perianal area, as well as a lower-lip ulcer and multiple pustules over the right forehead, right soft palate, left flank, right upper back, and perianal area.
Patient 2 was 37 years of age at the time of diagnosis. He presented with rectal bleeding, fever, and fatigue 11 days following receptive anal intercourse. Three days later, he developed painful, pruritic, pustular skin lesions over the perianal area, the limbs, and the trunk. Pustular lesions also were noted at the site of an insect bite site over the right wrist, as well as at an abrasion over the right forearm.
Laboratory findings were negative for HIV, syphilis, gonorrhea, and chlamydia in both patients. However, lesion samples obtained from both patients were positive orthopoxvirus DNA via Polymerase chain reaction testing.
Patient 1 and Patient 2 were started on a 14-day course of oral tecovirimat 600 mg twice daily at days 9 and 10 following symptom onset, respectively. Patient 1 reported no adverse effects throughout his treatment course, with rectal symptoms and skin lesions resolving by day 7. Similar findings were observed in patient 2, with rectal symptoms nearly resolving by day 4. However, patient 2 experienced mild transient fatigue during his treatment course.
“Although the direct effect of tecovirimat in precipitating the rapid alleviation of these patients’ symptoms cannot be determined, we believe that early use of tecovirimat should be considered for patients with monkeypox and severe proctitis until randomized controlled trials of tecovirimat can be done,” the study authors concluded.
We spoke with lead author Tara Palmore, MD, for further insight into these findings. Dr Palmore is a Professor of Medicine in the Division of Infectious Diseases at George Washington University, as well as a Hospital Epidemiologist at George Washington University Hospital.
What measures need to be taken to ensure wider and timely access to antivirals for monkeypox, such as tecovirimat?
Dr Palmore: A very important issue in expanding the use of antivirals for monkeypox is ensuring that clinicians recognize and test for monkeypox and are willing to prescribe antiviral therapy. In some areas, testing is not being performed in urgent care centers and primary care offices, which leaves patients in pain and delays both diagnosis and effective treatment. In addition, some clinicians are reluctant to seek informed consent and complete the form to initiate tecovirimat therapy. This hesitancy may further limit access to treatment for patients. The CDC has lowered the barrier to treatment by making the paperwork for expanded access to investigational new drugs very streamlined and simple — it takes less time than completing a prior authorization.
What role might local health departments play in expanding tecovirimat access?
Dr Palmore: Some local health departments are playing active roles in distributing tecovirimat to clinicians, as well as directly to patients. Although the resources of local health departments are stretched thin right now, many are rising to the occasion and serving patients with monkeypox infection through antiviral distribution, vaccinating high-risk individuals with pre-exposure prophylaxis, and providing testing at sexual health clinics.
Antiviral efficacy may be reduced in immunocompromised patients, according to results of studies performed in animal models. Is there a role for tecovirimat use in this population?
Dr Palmore: Tecovirimat should be used in immunocompromised persons with monkeypox infection as they are at high risk of progressing to severe disease from the viral infection.
How would you advise risk-benefit counseling conversations with patients, as tecovirimat is still classified as investigational?
Dr Palmore: Because placebo-controlled clinical trials of tecovirimat for monkeypox infection have not yet been completed, we do not know the actual benefit of the antiviral for monkeypox infection, or the optimal timing of treatment. Although anecdotal experience such as ours suggests that tecovirimat may accelerate recovery, clinical trials are important for characterizing the effect of tecovirimat on the natural history of monkeypox infection, which is usually self-limited without treatment. Regarding risks, there are published safety data. Based on those data and my own patients’ experience, I usually advise patients that tecovirimat has a generally mild adverse-effect profile.
Disclosures: One author declared affiliations with industry. Please see the reference for a full list of disclosures.
Lucar J, Roberts A, Saardi KM, Yee R, Siegel MO, Palmore TN. Monkeypox virus-associated severe proctitis treated with oral tecovirimat: a report of two cases. Ann Intern Med. Published online August 18, 2022. doi:10.7326/L22-0300