Opoksa
Leczenie

Większość pacjentów z opoksą (mpox) bez ciężkiego niedoboru odporności wyzdrowieje dzięki leczeniu objawowemu, obejmującemu kontrolę bólu (acetaminofen, NLPZ), odpowiednie nawodnienie, pielęgnację skóry oraz leczenie współistniejących zakażeń, w tym HIV. W przypadku zmian skórnych zaleca się utrzymanie ich w czystości i suchości, stosowanie miejscowych środków znieczulających oraz doustnych leków przeciwhistaminowych. Tekowirymat, lek przeciwwirusowy hamujący białko p37 ortopokswirusów, jest dostępny w ramach protokołu CDC EA-IND dla pacjentów z ciężkim niedoborem odporności (np. HIV z CD4 <200 komórek/mm³), kobiet w ciąży, dzieci oraz osób z przedłużającymi się lub zagrażającymi życiu objawami. Standardowa dawka tekowirymatu to 600 mg co 12 godzin przez 14 dni dla pacjentów o masie ciała ≥40 kg do <120 kg. Badania PALM007 i STOMP nie wykazały skrócenia czasu gojenia ani zmniejszenia bólu, jednak lek jest dobrze tolerowany.

Leczenie ospopodobnych zmian opoksy

Większość pacjentów z opoksą (mpox) bez ciężkiego niedoboru odporności wyzdrowieje przy zastosowaniu wyłącznie leczenia objawowego i kontroli bólu. Obecnie nie istnieje leczenie zatwierdzone specjalnie do stosowania w zakażeniach wirusem opoksy, jednak dostępne są leki regulowane przez FDA, które mogą pomóc w ciężkich przypadkach lub u pacjentów z grupy wysokiego ryzyka12. Pacjenci z opoksą mogą doświadczać poważnych manifestacji choroby, w tym zakażeń ocznych, powikłań neurologicznych, zapalenia mięśnia sercowego lub osierdzia, powikłań związanych ze zmianami na błonach śluzowych oraz powikłań wynikających z niekontrolowanego rozprzestrzeniania się wirusa z powodu umiarkowanego lub ciężkiego niedoboru odporności, szczególnie zaawansowanego zakażenia HIV1.

Leczenie objawowe

Leczenie objawowe to podstawa terapii opoksy i obejmuje34:

  • Kontrolę bólu za pomocą leków przeciwbólowych (acetaminofen, NLPZ)
  • Utrzymanie odpowiedniego nawodnienia i odżywienia
  • Pielęgnację skóry i zapobieganie wtórnym zakażeniom
  • Leczenie współistniejących zakażeń, w tym HIV

W przypadku zmian na skórze zaleca się56:

  • Utrzymywanie zmian skórnych w czystości i suchości w celu zapobiegania wtórnym zakażeniom
  • Stosowanie płynów do płukania jamy ustnej i miejscowych środków znieczulających w przypadku zmian w jamie ustnej
  • Leczenie świądu za pomocą doustnych leków przeciwhistaminowych i środków miejscowych (np. płyn kalaminowy, kortyzol 10% lub wazelina)
  • Kąpiele nasiadowe (sitz baths) trwające co najmniej 10 minut kilka razy dziennie w przypadku bolesnych zmian w okolicy odbytu i narządów płciowych

Leki przeciwwirusowe w leczeniu opoksy

Tekowirymat (TPOXX)

Tekowirymat to lek przeciwwirusowy opracowany do leczenia ospy prawdziwej, który jest dostępny do leczenia określonych pacjentów z opoksą w ramach protokołu CDC Expanded Access-Investigational New Drug (EA-IND)7. Tekowirymat działa poprzez hamowanie białka p37 ortopokswirusów, które jest niezbędne do tworzenia zakaźnych cząstek wirusa i rozprzestrzeniania się w organizmie gospodarza89.

Wskazania do zastosowania tekowirymatu według protokołu EA-IND obejmują pacjentów z1011:

  • Ciężkim niedoborem odporności (np. HIV z CD4 <200 komórek/mm³)
  • Aktywnymi chorobami skóry zwiększającymi ryzyko rozsianych zakażeń (np. atopowe zapalenie skóry)
  • Ciążą lub w okresie karmienia piersią
  • Wiek poniżej 18 lat
  • Przedłużającymi się lub zagrażającymi życiu objawami opoksy, w tym chorobą oczu

Zalecana dawka tekowirymatu zależy od masy ciała pacjenta; dla osób o wadze ≥40 kg do <120 kg dawka wynosi 600 mg co 12 godzin. Standardowy czas trwania leczenia wynosi 14 dni, choć pacjenci z niedoborami odporności mogą wymagać dłuższego leczenia12.

Wstępne analizy badań klinicznych z randomizacją (PALM007 i STOMP) oceniających skuteczność i bezpieczeństwo tekowirymatu u osób z opoksą wykazały, że tekowirymat nie skrócił czasu gojenia się zmian opoksy wśród dzieci i dorosłych z opoksą kladu I w Demokratycznej Republice Konga ani nie wpłynął na ból u dorosłych z łagodną do umiarkowanej opoksą kladu II131415. Nie odnotowano obaw dotyczących bezpieczeństwa związanych z tekowirymatem11.

Cidofowir i brincidofowir

Cidofowir jest analogiem nukleotydowym zatwierdzonym przez FDA do dożylnego leczenia zapalenia siatkówki wywołanego przez cytomegalowirusa. Działa jako fałszywy nukleotyd, który jest wbudowywany do replikującego się DNA wirusa przez wirusową polimerazę DNA, hamując syntezę DNA1617.

Brincidofowir (znany również jako Tembexa lub CMX001) jest doustną prolinią cidofowiru, która może być podawana doustnie i ma mniejszą nefrotoksyczność niż cidofowir1816. W 2021 roku FDA zatwierdziła brincidofowir do podawania doustnego w leczeniu ospy u dorosłych i dzieci na podstawie skuteczności w modelach zwierzęcych zakażenia ortopokswirusami19.

Cidofowir i brincidofowir mogą być rozważane jako uzupełniające leczenie w przypadku pacjentów z ciężką postacią opoksy lub jako alternatywa dla tekowirymatu, jeśli istnieją przeciwwskazania do jego stosowania1320.

Immunoglobulina Vaccinia (VIGIV)

Immunoglobulina Vaccinia podawana dożylnie (VIGIV) to leczenie polegające na podawaniu przeciwciał skierowanych przeciwko wirusowi vaccinia, które może oferować pewną ochronę przed opoksą. Ta terapia może być szczególnie korzystna dla osób z obniżoną odpornością, takich jak osoby z zaawansowanym HIV, które mogą nie być w stanie wytworzyć odpowiedniej odpowiedzi przeciwciał na zakażenie21.

VIGIV może być również rozważana do profilaktycznego zastosowania w celu zapobiegania opoksie u osób narażonych na wirusa opoksy, które są albo ciężko immunosupresyjne, albo mają przeciwwskazania do szczepienia przeciwko opoksie22.

Leczenie przypadków szczególnych

Zakażenia oczne

Zajęcie oka przez opoksę (np. zapalenie spojówek, zapalenie powiek, zapalenie rogówki, owrzodzenie rogówki) jest rzadkie, ale gdy występuje, wymaga pilnego leczenia, ponieważ bliznowacenie rogówki i utrata wzroku są potencjalnymi powikłaniami8.

U pacjentów z oczną postacią opoksy zaleca się2321:

  • Konsultację z okulistą
  • Szybkie wdrożenie ogólnoustrojowej terapii przeciwwirusowej wraz z miejscowym trifluridynem
  • Instruowanie pacjentów, aby unikali dotykania oczu i powstrzymali się od noszenia soczewek kontaktowych

Pacjenci z niewydolnością immunologiczną

Pacjentom z niedoborami odporności (np. HIV z liczbą CD4 <350 komórek/mm3, pacjenci po przeszczepach, leczeni immunosupresyjnie) zaleca się wczesne rozpoczęcie terapii przeciwwirusowej, gdyż są oni narażeni na ciężki przebieg choroby2425.

W przypadku pacjentów z HIV i opoksą2627:

  • Terapia antyretrowirusowa (ART) powinna być kontynuowana lub rozpoczęta w ciągu 7 dni od diagnozy HIV
  • Tekowirymat może być stosowany jako lek pierwszego wyboru
  • W przypadkach ciężkiego niedoboru odporności należy rozważyć leczenie skojarzone w momencie pierwszego kontaktu medycznego

W przypadku ciężkiej choroby Panel zaleca wczesną interwencję z terapią skojarzoną w momencie pierwszego kontaktu medycznego, w porozumieniu z CDC lub ekspertem w leczeniu opoksy27.

Kobiety w ciąży i karmiące piersią

Osoby w ciąży lub niedawno po ciąży z opoksą powinny być leczone w porozumieniu ze specjalistą chorób zakaźnych, jeśli to możliwe26. Wytyczne CDC sugerują leczenie przeciwwirusowe tekovirymatem dla objawowych kobiet w ciąży i karmiących piersią z opoksą2628.

Zalecenie to opiera się na obawach dotyczących28:

  • Zwiększonego ryzyka ciężkiego przebiegu choroby dotykającego osobę w ciąży
  • Ryzyka przeniesienia wirusa opoksy na płód podczas ciąży lub na noworodka podczas i po porodzie
  • Ryzyka ciężkiego zakażenia u noworodka, jeśli zostanie zakażony

Leczenie skojarzone w ciężkich przypadkach

W przypadku pacjentów z przedłużającymi się lub zagrażającymi życiu objawami opoksy lub pacjentów z wysokim ryzykiem takich objawów z powodu ciężkich stanów immunosupresyjnych, należy rozważyć leczenie skojarzone2429.

Scenariusze, w których terapia skojarzona może być pomocna, obejmują30:

  • Zakażenia oczne
  • Osoby z przedłużającymi się lub zagrażającymi życiu objawami opoksy (np. z powodu ciężkiego niedoboru odporności, takiego jak HIV z liczbą komórek CD4 <200 komórek/mm³)

W takich przypadkach leczenie tekovirymatem powinno być podawane wcześnie w przebiegu choroby wraz z leczeniem wspomagającym i kontrolą bólu. Rozsądne jest również rozważenie rozpoczęcia leczenia tekovirymatem u tych pacjentów w połączeniu z dożylnym cidofowirem lub doustnym brincidofowirem i/lub immunoglobuliną vaccinia (VIGIV)24.

Strategia kontroli bólu

Wielu pacjentów z opoksą doświadcza znacznego bólu związanego ze zmianami skórnymi lub zajęciem błon śluzowych, w tym zapaleniem odbytnicy lub zapaleniem gardła3132.

Strategie zarządzania bólem powinny być zindywidualizowane i skoncentrowane na pacjencie, dostosowane do potrzeb i kontekstu każdego pacjenta33:

  • Leki dostępne bez recepty (np. acetaminofen, NLPZ) są zalecane do ogólnej kontroli bólu u pacjentów z opoksą
  • Miejscowe sterydy i środki znieczulające, takie jak lidokaina, mogą być rozważane do miejscowego uśmierzania bólu
  • W niektórych okolicznościach leki przeciwbólowe na receptę, takie jak gabapentyna i opioidy, były stosowane do krótkotrwałego leczenia silnego bólu, który nie ustępował pod wpływem innych wymienionych powyżej metod leczenia

Stosowanie opioidów do kontroli bólu powinno być zrównoważone z ryzykiem działań niepożądanych, takich jak zaparcia, innymi zagrożeniami związanymi z niezamierzonym długotrwałym stosowaniem opioidów, ryzykiem rozwoju zaburzeń związanych z używaniem opioidów lub przedawkowaniem34.

Leczenie nadkażeń bakteryjnych

U pacjentów z opoksą mogą wystąpić wtórne zakażenia bakteryjne12. Wybór antybiotyków powinien opierać się na wynikach posiewów lub testów (jeśli są dostępne), miejscu anatomicznym, indywidualnych czynnikach ryzyka pacjenta, historii i lokalnych wzorcach oporności na środki przeciwdrobnoustrojowe35.

Wnioski i przyszłe kierunki w leczeniu opoksy

Mimo że dostępne są różne opcje terapeutyczne dla pacjentów z opoksą, badania kliniczne wykazały, że większość pacjentów z opoksą, którzy nie mają ciężkiej choroby lub czynników ryzyka ciężkiej choroby (np. ciężkiego niedoboru odporności), wyzdrowieje przy zastosowaniu leczenia wspomagającego i kontroli bólu24.

Rola tekowirymatu w leczeniu opoksy u pacjentów z ciężkim niedoborem odporności, w tym z zaawansowanym HIV, nie została określona i wymaga dodatkowych badań klinicznych1324. Tekowirymaty ze Strategicznej Krajowej Rezerwy (SNS) pozostają dostępne do leczenia opoksy u pacjentów, którzy mają lub są narażeni na wysokie ryzyko ciężkiej choroby, zgodnie z protokołem rozszerzonego dostępu CDC13.

Prowadzone są dalsze badania nad rozwojem skutecznych terapii przeciwwirusowych i immunologicznych. Przyszłe kierunki obejmują36:

  • Badanie leków opartych na przeciwciałach monoklonalnych, które mogą oferować skuteczne opcje leczenia
  • Terapie immunologiczne w celu zmniejszenia liczby ciężkich przypadków
  • Skojarzone leczenie przeciwwirusowe z immunoterapią, które może być bardziej skuteczne i zapewniać większe korzyści kliniczne niż sama monoterapia przeciwwirusowa

W przypadku większości pacjentów z opoksą bez ciężkiej choroby, koncentracja na leczeniu objawowym, kontroli bólu i zapobieganiu powikłaniom pozostaje podstawą terapii15.

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  1. 10.04.2026
  2. www.leksykon.com.pl

Materiały źródłowe

  • #1 Clinical Treatment of Mpox | Mpox | CDC
    https://www.cdc.gov/mpox/hcp/clinical-care/index.html
    Most mpox patients without severe immunocompromise will recover with supportive care and pain control only. […] Patients who are severely ill from mpox or have high-risk conditions that put them at risk for more severe mpox may benefit from mpox-directed treatment. […] There are no treatments specifically for mpox, but there are FDA-regulated medications that may help. […] Currently there is no treatment approved specifically for monkeypox virus (MPXV) infections. […] However, some patients have experienced severe manifestations of mpox, including ocular infections, neurologic complications, myopericarditis, complications associated with mucosal lesions, and complications from uncontrolled viral spread due to moderate or severe immunocompromise, particularly advanced HIV infection.
  • #2 Mpox (Monkeypox): Causes, Symptoms, Treatment & Prevention
    https://my.clevelandclinic.org/health/diseases/22371-monkeypox
    Theres no proven treatment for mpox, but it usually goes away on its own. […] If youre very sick or if youre pregnant, your provider might treat you with antiviral drugs, like tecovirimat (TPOXX) or cidofovir/brincidofovir. Vaccinia immune globulin (VIG-IV), a type of antibody treatment, is also sometimes an option. […] These drugs are approved to treat other viral infections (like smallpox) and could benefit some people. But researchers are still studying how well they work for mpox.
  • #3 Treatment and prevention of mpox (formerly monkeypox) – UpToDate
    https://www.uptodate.com/contents/treatment-and-prevention-of-mpox-formerly-monkeypox
    In the United States, tecovirimat remains an investigational agent for treatment of mpox. […] The recommended dose of tecovirimat depends upon the patient’s weight; as an example, for those ≥40 kg to <120 kg, the dose is 600 mg every 12 hours. [...] The duration of treatment is typically 14 days. [...] However, immunocompromised patients may require a longer course of therapy. [...] Monitoring response to therapy — The standard duration of tecovirimat is 14 days. [...] Management of bacterial superinfection — Secondary bacterial infections can occur in patients with mpox. [...] Management of other complications — For patients with severe mpox, other treatment modalities may be needed in addition to antiviral therapy. [...] Vaccination to prevent disease — There are two available orthopoxvirus vaccines that can reduce the risk of developing mpox.
  • #4
    https://www.who.int/news-room/fact-sheets/detail/mpox
    Mpox is treated with supportive care for symptoms such as pain and fever, with close attention to nutrition, hydration, skin care, prevention of secondary infections and treatment of co-infections, including HIV where present. […] The goal of treating mpox is to take care of the rash, manage pain and prevent complications. Early and supportive care is important to help manage symptoms and avoid further problems. […] Getting an mpox vaccine can help prevent infection (pre-exposure prophylaxis). It is recommended for people at high-risk of getting mpox, especially during an outbreak. […] Some antivirals have received emergency use authorization in some countries and are being evaluated in clinical trials. To date, there is no proven effective antiviral treatment for mpox. It is a priority to continue evaluation of therapeutics in robust clinical trials and to focus on optimizing supportive care for patients. […] Individuals with HIV and mpox should continue taking their antiretroviral therapy (ART). ART should be initiated within 7 days of diagnosis of HIV.
  • #5 Mpox (Monkeypox) – symptoms, treatment and prevention | healthdirect
    https://www.healthdirect.gov.au/monkeypox
    If you have recently returned from overseas or been in contact with someone diagnosed with mpox (monkeypox) and you develop symptoms, seek urgent medical attention. Contact your doctor or local hospital. […] Treatment is aimed at relieving symptoms and includes simple pain medicines and staying hydrated. […] Most people have mild mpox and do not need specific treatment, although your doctor may prescribe treatment for symptoms or complications. For example, you may need pain medicines or antibiotics if you develop a skin infection from your rash. […] If you have severe mpox or serious complications, you may need antiviral medicines, intravenous (IV) fluids or other medicines. Depending on your situation you may need treatment at a hospital that can give you the appropriate care or at an outpatient clinic. […] You should isolate at home until all your blisters or sores have healed and a healthy layer of skin has grown over the sores.
  • #6 Mpox for Healthcare Providers
    https://www.health.ny.gov/diseases/communicable/zoonoses/mpox/providers/
    Supportive care includes: […] Keeping skin lesions clean and dry to prevent further secondary infection (Oral antiseptics help keep lesions clean; Topical gels such as benzocaine/lidocaine can be used for temporary relief, while eating and drinking). […] Treating pruritus with oral antihistamines and topical agents (e.g., calamine lotion, cortisone 10, or petroleum jelly). […] Prescribing medicated mouthwashes for oral lesions to manage pain. […] Recommending stool softeners and sitz baths to help manage proctitis which can occur with or without lesions. […] Managing pain with medications such as acetaminophen or prescription medications (narcotics risk constipation). […] Managing nausea and vomiting with anti-emetics, and diarrhea with proper hydration and electrolyte replacement.
  • #7 Clinical Treatment of Mpox | Mpox | CDC
    https://www.cdc.gov/mpox/hcp/clinical-care/index.html
    Interim clinical guidance developed by CDC may assist clinicians in managing patients with protracted or life-threatening manifestations of mpox. […] Treatment for these patients involves Food and Drug Administration (FDA) regulated drugs and biologics that are primarily stockpiled by the U.S. government. […] Tecovirimat is an antiviral that was made available for treatment of certain patients with mpox under the CDC-held Expanded Access-Investigational New Drug (EA-IND) protocol during the global outbreak of mpox that began in 2022. […] While it may be reasonable to anticipate that tecovirimat may provide benefit in treating some people with mpox, it was unknown whether and how the efficacy in animals may translate to humans with active disease. […] Randomized clinical trials were launched in 2022 to evaluate the efficacy and safety of tecovirimat in people with mpox.
  • #8 Treatment and prevention of mpox (formerly monkeypox) – UpToDate
    https://www.uptodate.com/contents/treatment-and-prevention-of-mpox-formerly-monkeypox
    After treatment is initiated, patients should be followed closely to ensure medications are taken properly and to monitor the response to therapy. […] Ocular infections — Mpox involvement of the eye (eg, conjunctivitis, blepharitis, keratitis, corneal ulceration) is rare, but when present requires urgent treatment since corneal scarring and vision loss are potential complications. […] Patients with ocular mpox should be managed in consultation with an ophthalmologist. […] Specific agents — Several antivirals may be useful for the treatment of mpox (tecovirimat, brincidofovir, cidofovir). […] Tecovirimat (also referred to as TPOXX) is a potent inhibitor of an orthopoxvirus protein required for the formation of an infectious virus particle that is essential for dissemination within an infected host.
  • #9 Mpox (formerly monkeypox): pathogenesis, prevention and treatment | Signal Transduction and Targeted Therapy
    https://www.nature.com/articles/s41392-023-01675-2
    Currently, researchers are devoted to developing anti-Mpox drugs by interfering with the DNA or RNA synthesis of the viral genome. […] Cidofovir, a non-cyclic monophosphate nucleoside analog, can be used for the treatment of orthopoxviruses and demonstrate potent antiviral activity in vitro (Mpox virus, effective concentration half maximal (EC50)=2.52g/mL, Selectivity index (SI)=15, in human embryonic lung fibroblasts) and in vivo (Mpox virus, 5mg/kg, cynomolgus macaques, intraperitoneal injection; Mpox virus, 5mg/kg, human, intravenous). […] Following the Mpox outbreak in 2022, Cidofovir was rapidly employed in clinical trials for the treatment of Mpox. […] In order to overcome the limitations of Cidofovir, its derivative Brincidofovir has been developed. […] Apart from Brincidofovir, other compounds based on structural modifications of Cidofovir have been developed. […] Ribavirin, a well-known nucleoside analog, blocks viral nucleotide synthesis and thus inhibits viral replication and transmission. […] Although nucleotide analogs possess potent antiviral effects, they also have the potential to induce viral resistance. […] Tecovirimat, initially named ST-246, is a compound discovered through high-throughput screening (HTS) that exhibits potent antiviral activity against Mpox virus in vitro (Mpox virus, EC50=0.01M, in Vero cells) and in vivo (Mpox virus, 10mg/kg, cynomolgus macaques, gavage; Mpox virus, human, 600mg bid, oral). […] Tecovirimat functions by inhibiting the synthesis of the VP37 protein, thereby impeding the maturation process of orthopoxviruses and disrupting their envelopment and release. […] Tecovirimat primarily restricts intercellular virus spread without affecting the viral replication process.
  • #10 Treatment and prevention of mpox (formerly monkeypox) – UpToDate
    https://www.uptodate.com/contents/treatment-and-prevention-of-mpox-formerly-monkeypox
    Treatment and prevention of mpox (formerly monkeypox) […] Management of patients with mpox involves supportive care as well as antiviral therapy for select patients. […] Antiviral therapy — Several antivirals may be useful for the treatment of mpox. […] We suggest antiviral therapy for the following groups of patients with confirmed mpox or with suspected mpox pending confirmation […] Patients who are severely immunocompromised […] Patients with active skin conditions placing them at higher risk for disseminated infection […] Persons who are pregnant or lactating, regardless of illness severity or underlying comorbidities at presentation […] Persons <18 years of age, regardless of illness severity or underlying comorbidities at presentation [...] Patients with protracted or life-threatening manifestations of mpox, including ocular disease.
  • #11 Healthcare Providers – Mpox
    https://www.vdh.virginia.gov/monkeypox/healthcare-providers/
    Supportive care for mpox includes pain management, skin and wound care, maintenance of fluid balance, and treatment of co-occurring sexually transmitted infections or bacterial superinfections. CDC’s Clinical Considerations for Pain Management of Mpox has more details. […] For most individuals with intact immune systems, supportive care and pain control will be sufficient for management. In some patients, supportive care and pain control may not be adequate and treatment should be considered. Tecovirimat or TPOXX is considered as first line treatment of mpox in people who have advanced or poorly controlled HIV or are otherwise immunocompromised, as they may be at high risk for severe disease. It is important to begin tecovirimat as early as possible in such patients. […] Interim analysis from the STOMP trial found that tecovirimat did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease. There were no safety concerns associated with tecovirimat.
  • #12 Treatment and prevention of mpox (formerly monkeypox) – UpToDate
    https://www.uptodate.com/contents/treatment-and-prevention-of-mpox-formerly-monkeypox
    In the United States, tecovirimat remains an investigational agent for treatment of mpox. […] The recommended dose of tecovirimat depends upon the patient’s weight; as an example, for those ≥40 kg to <120 kg, the dose is 600 mg every 12 hours. [...] The duration of treatment is typically 14 days. [...] However, immunocompromised patients may require a longer course of therapy. [...] Monitoring response to therapy — The standard duration of tecovirimat is 14 days. [...] Management of bacterial superinfection — Secondary bacterial infections can occur in patients with mpox. [...] Management of other complications — For patients with severe mpox, other treatment modalities may be needed in addition to antiviral therapy. [...] Vaccination to prevent disease — There are two available orthopoxvirus vaccines that can reduce the risk of developing mpox.
  • #13 Clinical Treatment of Mpox | Mpox | CDC
    https://www.cdc.gov/mpox/hcp/clinical-care/index.html
    Initial analyses released in August 2024 indicated that tecovirimat did not reduce the duration of mpox lesions among children and adults with clade I mpox in DRC. […] The role of tecovirimat in treatment of mpox in patients with severe immunocompromise, including advanced HIV, has not been determined and requires additional clinical trials. […] Tecovirimat from the Strategic National Stockpile (SNS) will remain available for treatment of mpox in patients who have or are at high risk for severe illness as defined in the CDC-held expanded access IND protocol. […] Tecovirimat is typically the first therapeutic that is considered if patients with mpox require more than supportive care. […] Brincidofovir and Vaccinia Immune Globulin (VIGIV) are additional therapeutics, available from the SNS, that can be considered for treatment of mpox in certain patients who might benefit from combination therapy with tecovirimat or may require an alternative treatment to tecovirimat.
  • #14 Tecovirimat (TPOXX) for Treatment of Mpox | Mpox | CDC
    https://www.cdc.gov/mpox/hcp/clinical-care/tecovirimat.html
    Tecovirimat (also known as TPOXX or ST-246) is an antiviral drug stockpiled for smallpox preparedness. […] The use of tecovirimat for the treatment of infections caused by viruses related to the smallpox virus, including monkeypox virus, is investigational. […] Initial analysis of data from two randomized clinical studies designed to assess the efficacy and safety of tecovirimat in treating mpox showed that tecovirimat was safe but didn’t reduce the time to resolution of mpox lesions. […] Tecovirimat from the Strategic National Stockpile remains available under CDC’s expanded access Investigational New Drug protocol only for eligible patients. […] They showed that tecovirimat was safe but the antiviral did not reduce the time to resolution of mpox lesions in participants who received tecovirimat compared to participants who received placebo.
  • #15 Mpox Treatment | NIAID: National Institute of Allergy and Infectious Diseases
    https://www.niaid.nih.gov/diseases-conditions/mpox-treatment
    There is currently no treatment approved for mpox in the United States. However, there are several antiviral medications approved for smallpox that may help people with mpox, and evidence is building on the role of supportive management to alleviate the symptoms and complications of mpox. […] In August 2024, NIAID announced that tecovirimat did not reduce the duration of mpox lesions among children and adults with clade I mpox in the Democratic Republic of the Congo (DRC), based on an initial analysis of data from PALM007, a randomized, placebo-controlled trial. […] This shows that better outcomes among people with mpox can be achieved when they are hospitalized and provided high-quality supportive care. […] In September 2022, NIAID started a clinical trial of tecovirimat in the United States and other countries affected by clade II mpox.
  • #16 Prevention and Treatment of Mpox – NCBI Bookshelf
    https://www.ncbi.nlm.nih.gov/books/NBK603707/
    Tecovirimat has been the preferred antiviral agent during the 2022 mpox outbreak. It was originally developed for the treatment of smallpox (caused by variola, another orthopoxvirus) and approved by the FDA in 2018 through the animal rule based on animal efficacy studies. This medication acts by targeting the p37 protein, a component of the viral envelope in the mpox virus and related orthopoxviruses. Tecovirimat was made available through an expanded access investigational new drug (EA-IND) protocol and has been provided to more than 6,800 people during the 2022 mpox outbreak. […] Cidofovir and its derivative, brincidofovir, are antiviral drugs that block DNA polymerase, thus stopping further DNA synthesis and leading to nonproductive infection. Cidofovir is approved by the FDA for intravenous treatment of cytomegalovirus retinitis. Animal studies suggest cidofovir might be effective against orthopoxviruses, but there are no human data yet to confirm its effectiveness in treating mpox.
  • #17 Treatment and prevention of mpox (formerly monkeypox) – UpToDate
    https://www.uptodate.com/contents/treatment-and-prevention-of-mpox-formerly-monkeypox/print
    Tecovirimat (also referred to as TPOXX) is a potent inhibitor of an orthopoxvirus protein required for the formation of an infectious virus particle that is essential for dissemination within an infected host. […] In the United States, tecovirimat remains an investigational agent for treatment of mpox. […] The recommended dose of tecovirimat depends upon the patient’s weight; as an example, for those ≥40 kg to <120 kg, the dose is 600 mg every 12 hours. [...] The duration of treatment is typically 14 days. [...] Tecovirimat has generally been well tolerated in persons with pox. [...] Clinical trials evaluating the efficacy of tecovirimat in humans with pox are ongoing. [...] Cidofovir acts as a false nucleotide that is incorporated into the replicating viral DNA by the viral DNA polymerase.
  • #18 Mpox: Current Clinical Considerations on Antiviral Treatment – touchINFECTIOUS DISEASES
    https://touchinfectiousdiseases.com/viral-infections/journal-articles/mpox-current-clinical-considerations-on-antiviral-treatment/
    Brincidofovir also has decreased accumulation in the kidneys, resulting in less nephrotoxicity than cidofovir. […] Tecovirimat was considered a first-line but still investigational, antiviral for mpox. […] The use of tecovirimat for treatment is extrapolated from efficacy against other poxviruses and/or is based on in vitro/animal data. […] The future role of tecovirimat in mpox treatment is unclear. […] Vaccinia immunoglobulin is derived from the antibodies of people who have been vaccinated against smallpox. […] VGIV is administered intravenously based on patient weight as a single dose. […] Overall, the aforementioned antivirals may offer potential therapeutic benefits. Issues such as drug resistance, toxicity and the complexities of treatment, especially in immunocompromised individuals, must be carefully managed.
  • #19 Mpox Treatment | NIAID: National Institute of Allergy and Infectious Diseases
    https://www.niaid.nih.gov/diseases-conditions/mpox-treatment
    Adults with severe mpox or those at high risk for severe disease including individuals with underlying immune deficiency, a history of or active inflammatory skin conditions, pregnant women and children will be enrolled in an open-label arm in which all participants receive tecovirimat. […] NIAID funded preclinical studies of tecovirimat to determine its mechanism of action, safety, and efficacy. […] The Food and Drug Administration approved tecovirimat in 2018 for the treatment of smallpox in adults and children; the drug has been added to the U.S. Strategic National Stockpile for use in the event of an outbreak. […] NIAID also supported the early development of brincidofovir (Tembexa) as a treatment for smallpox. […] The FDA approved brincidofovir for oral administration in 2021 for the treatment of smallpox in adults and children based on efficacy in animal models of Orthopoxvirus infection.
  • #20 Treatment and prevention of mpox (formerly monkeypox) – UpToDate
    https://www.uptodate.com/contents/treatment-and-prevention-of-mpox-formerly-monkeypox
    In the United States, these patient groups meet the criteria to receive tecovirimat through the EA-IND protocol, which is available through the CDC. […] For patients with mpox who warrant antiviral therapy, we suggest tecovirimat given its potential efficacy for treating orthopoxvirus infections in animal models, its safety profile, and accumulating data on treating mpox in humans. […] In some countries, such as the United States, tecovirimat is an investigational agent. […] If tecovirimat (either outside or within a clinical trial) is not available, the decision to treat with an alternative agent such as cidofovir or brincidofovir should be individualized, taking into account the severity of disease, as the risk of complications is greater with these agents. […] In addition to using antiviral medications, efforts should be made to improve the patient’s immune function.
  • #21 Prevention and Treatment of Mpox – NCBI Bookshelf
    https://www.ncbi.nlm.nih.gov/books/NBK603707/
    Vaccinia immune globulin intravenous (VIGIV) treatment involves the administration of antibodies targeting the vaccinia virus and is thought to offer some protection against mpox. This therapy can be particularly advantageous for individuals with compromised immune systems, such as those with advanced HIV, who may be unable to produce an adequate antibody response to infection. […] The topical antiviral agent trifluridine has in vitro activity against orthopoxviruses and is approved by the FDA for treatment of eye infections caused by herpes simplex virus. Although efficacy for ocular mpox has not been established, trifluridine was used in the 2022 outbreak with anecdotal success.
  • #22 Clinical Treatment of Mpox | Mpox | CDC
    https://www.cdc.gov/mpox/hcp/clinical-care/index.html
    Decisions on whether and when to use these additional or alternative therapeutics must be made individually for each person and can depend on a variety of clinical and other parameters. […] VIGIV can also be considered for prophylactic use to prevent mpox in persons with MPXV exposure who are either severely immunocompromised or have a contraindication to receipt of mpox vaccination. […] It is unknown whether a person with severe mpox will benefit from treatment with cidofovir, although its use may be considered in such patients.
  • #23 Monkeypox (Mpox) Medication: Antiviral Agents, Vaccine, Live Virus, Antivirals, Ophthalmic
    https://emedicine.medscape.com/article/1134714-medication
    Antiviral agent indicated for treatment of human smallpox disease caused by variola virus in adults and children who weigh at least 13 kg. It is available under an expanded access (ie, compassionate use) investigational new drug protocol for adults and children (weighing at least 6 kg) for treatment of mpox. […] Cidofovir is a nucleotide analog that selectively inhibits viral DNA production in CMV and other herpes viruses. […] Indicated for treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. […] Clinician should consider prompt initiation of systemic antiviral therapy in addition to topical trifluridine in patients with ocular manifestations. […] The CDC recommend off-label use for mpox ocular infections.
  • #24 Tecovirimat (TPOXX) for Treatment of Mpox | Mpox | CDC
    https://www.cdc.gov/mpox/hcp/clinical-care/tecovirimat.html
    The findings from these clinical trials suggest that most patients with mpox who do not have severe disease or risk factors for severe disease (e.g., severe immunocompromise) will recover with supportive care and pain management. […] The role of tecovirimat in treatment of mpox in patients with severe immunocompromise, including advanced HIV, has not been determined and requires additional clinical trials. […] For patients with protracted or life-threatening manifestations or at high risk for protracted or life-threatening manifestations of mpox due to severe immunocompromising conditions, tecovirimat treatment should be administered early in the course of illness along with supportive care and pain control. […] It is also reasonable to consider initiating tecovirimat treatment in these patients in combination with either IV cidofovir or oral brincidofovir (the prodrug of cidofovir) and/or Vaccinia Immune Globulin (VIGIV). […] Tecovirimat use under the EA-IND is also covered under the Public Readiness and Emergency Preparedness (PREP) Act, which provides liability immunity to qualified providers and compensation to eligible patients via the Countermeasures Injury Compensation Program (CICP).
  • #25 Mpox: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/mpox
    Mpox vaccination should be offered to all people with HIV who have potential for mpox exposure or anticipate potential exposure to mpox per CDC interim clinical considerations (BII). […] JYNNEOS is the preferred vaccine following mpox exposure and is safe to use in people with HIV; administer JYNNEOS in two doses (0.1 mL ID or 0.5 mL SQ) 28 days apart as soon as possible and within 14 days after exposure to mpox (AII). […] People not presently taking ART should initiate treatment as soon as possible (AIII). […] Tecovirimat 600 mg PO every 12 hours (120 kg) or every 8 hours (120 kg) for 14 days (BIII) within 30 minutes of a fatty meal; or Tecovirimat 200 mg IV every 12 hours for 14 days (120 kg) or 300 mg IV every 12 hours (120 kg), if concern exists regarding altered gastrointestinal absorption capacity, the inability to take PO, or the extent of organ systems affected by mpox (BIII).
  • #26 Treatment and prevention of mpox (formerly monkeypox) – UpToDate
    https://www.uptodate.com/contents/treatment-and-prevention-of-mpox-formerly-monkeypox
    If symptoms develop — Exposed individuals should be isolated immediately if they develop signs and symptoms consistent with mpox. […] Special populations — Pregnant persons who are diagnosed with mpox or have had an exposure to mpox should be managed in consultation with an infectious diseases specialist, if possible. […] Antiviral therapy — The United States CDC guidance suggests antiviral treatment with tecovirimat for symptomatic pregnant and lactating persons with mpox. […] For persons with HIV who have mpox, anti-viral therapy should be used in those who are immunocompromised and at risk for severe disease.
  • #27 Mpox: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/mpox
    Patients with severe immunocompromise might benefit from extended treatment (i.e., 14 days) of preferred or adjunctive therapies if new confirmed mpox lesions occur or existing lesions worsen despite treatment. […] For severe disease, the Panel recommends early intervention with combination therapy at the time of the first medical encounter, in consultation with CDC or an expert in mpox treatment (CIII). […] Cidofovir 5 mg/kg/week IV for two doses with saline hydration before and after therapy and probenecid 2 g PO 3 hours before the dose followed by 1 g PO 2 hours after the dose, and 1 g PO 8 hours after the dose (total of 4 g) (BIII). […] Brincidofovir 200 mg PO once weekly for two doses (BIII), or VIGIV 6,0009,000 units/kg IV single dose (BIII). […] Tecovirimat can be used as a first-line antiviral during pregnancy as well as during breastfeeding or if recently pregnant (BIII). […] In people with advanced HIV (e.g., CD4 count 350 cells/mm3), those whose HIV viral load is unsuppressed, or those who otherwise merit treatment for mpox, ART should ideally be started at the same time as mpox therapy (AIII).
  • #28 Treatment and prevention of mpox (formerly monkeypox) – UpToDate
    https://www.uptodate.com/contents/treatment-and-prevention-of-mpox-formerly-monkeypox/print
    The risks and benefits of vaccination in persons who are pregnant or breastfeeding are outlined below. […] The United States CDC guidance suggests antiviral treatment with tecovirimat for symptomatic pregnant and lactating persons with mpox. […] The recommendation for treatment is based on concerns for an increased risk of severe disease affecting the pregnant person during pregnancy, the risk of transmitting monkeypox virus (MPXV) to the fetus during pregnancy or to the newborn during and after birth, and the risk of severe infection in the newborn, if infected. […] For persons with HIV who have mpox, anti-viral therapy should be used in those who are immunocompromised and at risk for severe disease.
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  • #31 Prevention and Treatment of Mpox – NCBI Bookshelf
    https://www.ncbi.nlm.nih.gov/books/NBK603707/
    Fortunately, the prognosis of mpox in the context of the 2022 clade IIb mpox outbreak is excellent, and the majority of affected individuals recover fully whether they receive medical attention or not. Supportive measures for pain and other symptom control as well as treatment of complications, such as bacterial superinfection, are the mainstays of therapy. Although there is no U.S. Food and Drug Administration (FDA)-approved therapy specifically for mpox, several antiviral medications developed for the treatment of infection with other pathogens have been repurposed as mpox medical countermeasures. […] Many patients with mpox will experience significant pain from skin lesions or mucosal involvement, including proctitis or pharyngitis. Although there is limited empirical evidence, the Centers for Disease Control and Prevention (CDC) has provided clinical considerations for supportive care and pain management of mpox based on the clinical experience of healthcare providers. Pain can often be controlled with over-the-counter analgesics such as acetaminophen or nonsteroidal anti-inflammatory medications. Some individuals may require treatment with gabapentin or opioid medications for severe pain. For patients with opioid use disorder on medication-assisted treatment, consider recommendations available in the U.S Department of Veterans Affairs Evidence Brief: Managing Acute Pain in Patients with Opioid Use Disorder on Medication-assisted Treatment.
  • #32 Prevention and Treatment of Mpox – Clinical Guidelines Program
    https://www.hivguidelines.org/guideline/sti-mpox/
    Fortunately, the prognosis of mpox in the context of the 2022 clade IIb mpox outbreak is excellent, and the majority of affected individuals recover fully whether they receive medical attention or not CDC(f) 2024. Supportive measures for pain and other symptom control as well as treatment of complications, such as bacterial superinfection, are the mainstays of therapy. Although there is no U.S. Food and Drug Administration (FDA)-approved therapy specifically for mpox, several antiviral medications developed for the treatment of infection with other pathogens have been repurposed as mpox medical countermeasures. […] Many patients with mpox will experience significant pain from skin lesions or mucosal involvement, including proctitis or pharyngitis. Although there is limited empirical evidence, the Centers for Disease Control and Prevention (CDC) has provided clinical considerations for supportive care and pain management of mpox based on the clinical experience of healthcare providers. Pain can often be controlled with over-the-counter analgesics such as acetaminophen or nonsteroidal anti-inflammatory medications. Some individuals may require treatment with gabapentin or opioid medications for severe pain. For patients with opioid use disorder on medication-assisted treatment, consider recommendations available in the U.S Department of Veterans Affairs Evidence Brief: Managing Acute Pain in Patients with Opioid Use Disorder on Medication-assisted Treatment.
  • #33 Treatment of Mpox: TPOXX & Supportive Care
    https://dph.illinois.gov/topics-services/diseases-and-conditions/mpox/treatment/mpox-treatment-tpoxx-and-supportive-care.html
    Studies using a variety of animal species have shown that TPOXX is effective in treating diseases caused by orthopoxviruses (viruses like mpox) and has been shown to decrease the chance of dying from infections with orthopoxviruses when given early in the disease course. […] TPOXX is administered through one of two methods. […] Pain management strategies should be individualized and patient-centered, tailored to the needs and context of each patient. […] Over-the-counter medications (e.g., acetaminophen, NSAIDs) are recommended for general pain control for patients with mpox. […] Topical steroids and anesthetics, such as lidocaine, can be considered for local pain relief. Topical lidocaine or other topical anesthetics should be used with caution on broken skin or open or draining wounds.
  • #34 Treatment of Mpox: TPOXX & Supportive Care
    https://dph.illinois.gov/topics-services/diseases-and-conditions/mpox/treatment/mpox-treatment-tpoxx-and-supportive-care.html
    In some circumstances, prescription pain medications, such as gabapentin and opioids, have been used for short-term management of severe pain not controlled with other treatments listed above. Use of opioids for pain control should be balanced against the risk of side effects such as constipation, other risks of unintended long-term use of opioids, a development of an opioid use disorder or overdose.
  • #35 Mpox: Treating severe lesions
    https://www.aad.org/member/clinical-quality/clinical-care/mpox/severe-lesions
    There is minimal data on the effectiveness of vaccinia immune globulin in mpox, but it may be considered for severe mpox cases. […] Antimicrobial selection should be based on any culture or testing results (when available), anatomic site of involvement, individual patient risk factors, history, and local antimicrobial resistance patterns. […] Pain management should be considered for both immediate and longer-term pain; NSAIDs may be used for acute pain, but opioids may be needed in more severe cases.
  • #36 Mpox (formerly monkeypox): pathogenesis, prevention and treatment | Signal Transduction and Targeted Therapy
    https://www.nature.com/articles/s41392-023-01675-2
    Antibody-based therapeutics have shown significant progress in treating certain infectious diseases and currently being actively explored. […] Immune globulin, convalescent plasma, and neutralizing antibodies offer promising options as adjunctive treatments for cases with insufficient antiviral drug efficacy in severe patients. […] Notably, individuals who have been previously vaccinated with the smallpox vaccine produce more neutralizing antibodies that may be cross-protective against Mpox virus infection. […] Therefore, mAbs drugs are most likely to provide effective clinical treatment outcomes in the development of anti-Mpox treatments compared to VIGIV and CP, which have uncertain efficacy. […] Mpox virus-induced immunopathology leads to adverse outcomes in clinical, and immunotherapy for Mpox has the potential to reduce severe cases. […] Combination antiviral drugs with immunotherapy may be more effective and provide greater clinical benefit than single antiviral therapy alone.