For systemic toxoplasmosis treatment, are outcomes better with pyrimethamine+sulfasalazine or trimethoprim-sulfamethoxazole (Bactrim)?

Comment by InpharmD Researcher

The National Institutes of Health (NIH) recommends the combination of pyrimethamine+sulfadiazine (P-S) plus leucovorin as the preferred initial therapy regimen for treatment of toxoplasmic encephalitis (TE) caused by Toxoplasma gondii. Due to direct comparative data demonstrating similar efficacy and safety (see Table 1), alternative use of trimethoprim-sulfamethoxazole (TMP-SMX) is recommended when pyrimethamine is not readily accessible. Meta-analyses based on available studies have also demonstrated comparable efficacy between P-S and TMP-SMX regimens, both in HIV patients with TE and patients with ocular toxoplasmosis. In general, the choice of therapy should be guided by drug availability, tolerability, costs, and the ability of patients to take medications orally, as treatment outcomes appear similar between the two regimens.

Background

According to the guidelines for prevention and treatment of Toxoplasmic encephalitis (TE) caused by the protozoan Toxoplasma gondii (T. gondii) in adults and adolescents with human immunodeficiency virus (HIV), the combination of pyrimethamine plus sulfadiazine plus leucovorin is recommended as the preferred regimen for the initial therapy (AI). In patients intolerant or not responding to the first-line regimen, pyrimethamine plus clindamycin plus leucovorin may be considered (AI). Use of pyrimethamine is preferred in the setting of TE mainly due to its characteristic of high penetration into the brain parenchyma, even in the absence of inflammation. [1]

With limited comparative trials, primarily small randomized trials or open-label observational studies (see Table 1), demonstrating similar efficacy of ​​trimethoprim-sulfamethoxazole (TMP-SMX) to pyrimethamine-sulfadiazine, the panel suggests TMP-SMX be utilized in place of pyrimethamine-sulfadiazine or pyrimethamine-clindamycin when pyrimethamine is not readily accessible (BI). Still, optimal regimens in patients who cannot take an oral regimen have yet to be well-established. As such, some specialists prefer to use parenteral TMP-SMX (BI) or oral pyrimethamine plus parenteral clindamycin (CIII) as initial treatment in severely ill patients who require parenteral therapy. [1]

Similar treatment protocols have also been discussed in the setting of toxoplasma disease in pediatric hematopoietic stem cell transplantation (HSCT) patients in compliance with guideline recommendations. In the presence of suspected or confirmed cases, patients should be treated immediately with anti-Toxoplasma therapy with first-line medications, including pyrimethamine, sulfadiazine, and leucovorin. Alternatively, intravenous (IV) TMP-SMX can be used until pyrimethamine becomes available or in patients with poor enteric absorption of oral medications (e.g., due to gastrointestinal graft-versus-host disease). Besides available statements extrapolated from published guidelines, the review article does not provide additional data in terms of comparative efficacy and safety between pyrimethamine, sulfadiazine, and leucovorin, and TMP-SMX. [2], [3]

A meta-analysis published in 2015 compared the efficacies of treatment options for T. gondii infections. The pooled cure rate of pyrimethamine-sulfadiazine (P-S) in TE was found to be 49.8% (95% confidence interval [CI] 38.8% to 60.8%) compared to 59.9% (95% CI 48.9% to 70%) with TMP-SMX. No significant difference was found between the two treatment modalities (p= 0.635). Of note, this analysis was limited to 7 publications utilizing P-S (n= 414 participants) and 3 publications utilizing TMP-SMX (n= 86 participants). [4]

Another meta-analysis published in 2021 evaluated the safety and efficacy of different antibiotic regimens in patients with ocular toxoplasmosis. Only one comparison of TMP-SMX and P-S was included in the analysis, which was derived from the study by Soheilian et al. (see Table 1). In this study, there was found to be no difference between TMP-SMX and P-S for resolution of vitreous inflammation (risk ratio 0.82; 95% CI 0.55 to 1.22). [5]

A review describing the treatment of toxoplasmosis notes that available data from meta-analyses and a limited number of clinical trials have observed no major differences between P-S regimens and TMP-SMX regimens in regard to safety and efficacy. While it is suggested that P-S is the current gold standard for treatment of acute TE in HIV patients, TMP-SMX seems to have similar clinical effectiveness. Regardless, the authors indicate that there has yet to be a regimen found to be superior to P-S. In general, the choice of therapy should be guided by drug availability, tolerability, costs, and the ability of patients to take medications enterally. [6]

References: [1] Toxoplasma gondii Encephalitis | NIH. clinicalinfo.hiv.gov. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Reviewed January 11, 2023. Accessed November 21, 2023. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/toxoplasma-gondii?view=full
[2] Schwenk HT, Khan A, Kohlman K, et al. Toxoplasmosis in Pediatric Hematopoietic Stem Cell Transplantation Patients. Transplant Cell Ther. 2021;27(4):292-300. doi:10.1016/j.jtct.2020.11.003
[3] Panel on Opportunistic Infections in Children with and Exposed to HIV. Guidelines for the Prevention and
Treatment of Opportunistic Infections in Children with and Exposed to HIV. Department of Health and Human
Services. Accessed November 21, 2023. https://clinicalinfo.hiv.gov/en/guidelines/pediatric-opportunistic-infection.
[4] Wei HX, Wei SS, Lindsay DS, Peng HJ. A Systematic Review and Meta-Analysis of the Efficacy of Anti-Toxoplasma gondii Medicines in Humans. PLoS One. 2015;10(9):e0138204. Published 2015 Sep 22. doi:10.1371/journal.pone.0138204
[5] Feliciano-Alfonso JE, Muñoz-Ortiz J, Marín-Noriega MA, et al. Safety and efficacy of different antibiotic regimens in patients with ocular toxoplasmosis: systematic review and meta-analysis. Syst Rev. 2021;10(1):206. Published 2021 Jul 19. doi:10.1186/s13643-021-01758-7
[6] Dunay IR, Gajurel K, Dhakal R, Liesenfeld O, Montoya JG. Treatment of Toxoplasmosis: Historical Perspective, Animal Models, and Current Clinical Practice. Clin Microbiol Rev. 2018;31(4):e00057-17. Published 2018 Sep 12. doi:10.1128/CMR.00057-17
Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

For systemic toxoplasmosis treatment, are outcomes better with pyrimethamine+sulfasalazine or trimethoprim-sulfamethoxazole (Bactrim)?

Level of evidence

A - Multiple high-quality studies with consistent results  Read more→



Please see Table 1 for your response.


Studies Comparing Pyrimethamine + Sulfasalazine versus Trimethoprim-Sulfamethoxazole for Treatment of Toxoplasmosis

Reference and Design Population Intervention

Results

Kongsaengdao et al., 20081

Randomized controlled trial

AIDS patients with TE

N= 30
P50-S (n= 10)
P100-S (n= 10)
TMP-SMX (n= 10)

 

Patients were randomized to receive a 6-week course of pyrimethamine 50 mg/day + sulfadiazine 4 g/day (P50-S) + folinic acid 25 mg/day, pyrimethamine 100 mg/day + sulfadiazine 4 g/day (P100-S) + folinic acid 25 mg/day, or trimethoprim 10 mg/kg/day plus sulfamethoxazole 50 mg/kg/day (TMP-SMX).

Patient death:

P50-S: 0% (p= 0.05 vs. TMP-SMX)

P100-S: 10%

TMP-SMX: 30%

Treatment failure:

P50-S: 30%

P100-S: 30%

TMP-SMX: 30%

Similar rates of adverse events between groups

Soheilan et al., 20052

Randomized controlled trial

Active ocular toxoplasmosis

N= 59
P-S (n= 29)
TMP-SMX (n= 30)

Patients were randomized to receive an initial dose of 100 mg pyrimethamine daily for 2 days, followed by a 25-mg dose daily, 2 g of sulfadiazine daily for 2 days followed by 500-mg dosing every 6 hours, and 5 mg of folinic acid daily (P-S) or 2 tablets of trimethoprim (80 mg)/sulfamethoxazole (400 mg) every 12 hours (TMP-SMX) for 6 weeks. Oral prednisolone was administered at 1 mg/kg daily starting from the third day of therapy, and the dose was tapered over 2 weeks.

Mean reduction of retinochoroidal lesion size:

P-S: 61%

TMP-SMX: 59%

p= 0.75

Mean visual acuity:

Pyrimethamine/sulfadiazine: 0.12 logMAR [20/25]

TMP-SMX: 0.09 logMAR [20/25]

p= 0.56

Similar rates of adverse events between groups

Torre et al., 19983

Randomized pilot study

AIDS patients with TE

N= 77
P-S (n= 37)
TMP-SMX (n= 40)

Patients were randomized to receive trimethoprim (10 mg/kg/day) with sulfamethoxazole (50 mg/kg/day) or pyrimethamine (50 mg daily) with sulfadiazine (60 mg/kg/day) as acute therapy for 4 weeks and then as maintenance therapy for 3 months at half of the original dosage.

Clinical response:

P-S: 65.7%

TMP-SMX: 62.1%

p= not significant

Complete radiological response:

P-S: 39.3%

TMP-SMX: 62.1%

p= 0.0478

Adverse reactions:

P-S: 37.8%

TMP-SMX: 12.5%

p= 0.0162

Abbreviations:

AIDS: acquired immune deficiency syndrome; P-S: pyrimethamine-sulfadiazine; TE: toxoplasmic encephalitis; TMP-SMX: trimethoprim-sulfamethoxazole

 

References:
[1] [1] Kongsaengdao S, Samintarapanya K, Oranratnachai K, Prapakarn W, Apichartpiyakul C. Randomized controlled trial of pyrimethamine plus sulfadiazine versus trimethoprim plus sulfamethoxazole for treatment of toxoplasmic encephalitis in AIDS patients. J Int Assoc Physicians AIDS Care (Chic). 2008;7(1):11-16. doi:10.1177/1545109707301244
[2] [2] Soheilian M, Sadoughi MM, Ghajarnia M, et al. Prospective randomized trial of trimethoprim/sulfamethoxazole versus pyrimethamine and sulfadiazine in the treatment of ocular toxoplasmosis. Ophthalmology. 2005;112(11):1876-1882. doi:10.1016/j.ophtha.2005.05.025
[3] [3] Torre D, Casari S, Speranza F, et al. Randomized trial of trimethoprim-sulfamethoxazole versus pyrimethamine-sulfadiazine for therapy of toxoplasmic encephalitis in patients with AIDS. Italian Collaborative Study Group. Antimicrob Agents Chemother. 1998;42(6):1346-1349. doi:10.1128/AAC.42.6.1346