Patients with latent TB receiving 3HP report symptoms resolved without stopping treatment
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Key takeaways:
- Patients receiving 3HP reported mostly mild symptoms that occurred early and resolved without stopping treatment.
- Nearly half of patients experiencing systemic drug reactions completed therapy regardless of their symptoms.
Most patients with latent tuberculosis receiving a once-weekly combination of rifapentine and isoniazid reported symptoms from the therapy that resolved without stopping treatment, researchers found.
“This study presents a more complete picture of symptoms and reactions to the 3 months of once-weekly isoniazid plus rifapentine treatment regimen (3HP), for latent TB infection,” Claire Sadowski, MPH, epidemiologist in CDC’s Division of Tuberculosis Elimination, told Healio.
Sadowski added that previous studies helped to define and identify drug reactions of high concern, like angioedema and hives, as well as “flu-like” symptoms, including nausea, fatigue and fever, and prospectively collected data on participants experiencing symptoms or reactions associated with the treatment.
“The data analyzed in this study allowed us to further examine drug reaction patterns in greater detail and explore the possibility of predicting or preventing drug reactions among people receiving the 3HP treatment regimen for tuberculosis prevention,” she said.
Sadowksi and colleagues analyzed symptom data for 1,002 patients receiving 3HP as part of the Tuberculosis Trials Consortium’s iAdhere study, which included the patterns of symptom reporting across four monthly visits. According to the study, the researchers used bivariate analyses and multivariable regression models to identify factors associated with systemic drug reactions (SDRs).
Among the 1,002 study participants, 768 (77%) reported at least one symptom, of which 97% were grade 1 (79%) or grade 2 (18%). Data collected showed that most symptoms developed in the first month and resolved.
Among participants who experienced a symptom while taking 3HP, 622 (81%) completed treatment without having to discontinue, whereas 146 (19%) participants did not complete treatment. Symptoms reported among those who did not complete treatment included headache (43%), fatigue (40%), nausea (40%) and weakness (31%).
Additionally, a total of 111 (11%) participants had symptoms that met criteria for SDRs — 16 of whom met category I criteria and 95 category II. According to the study, those who met category I SDR criteria had hypotension, hives, angioedema, wheezing/acute bronchospasm or conjunctivitis/red eyes, whereas the most common symptoms meeting criteria II were fatigue, headache, nausea and aches.
The researchers noted that 53 (48%) of patients with SDRs completed their therapy. They added that factors associated with SDRs and discontinuation included being female (RR = 2.05; 95% CI, 1.19-3.54), being aged 45 years and older (RR = 1.99; 95% CI, 1.19-3.31) and use of concomitant medications (RR = 2.26; 95% CI, 1.15-4.42). Among those using concomitant medications, the most common were cardiovascular medications (38%), vitamins/supplements (31%), nonsteroidal anti-inflammatory drugs (24%), psychiatric drugs (22%) and antihistamines (27%).
Overall, Sadowski said that these data demonstrate that shorter treatment regimens for latent TB infection, like 3HP, can be more convenient and help patients finish treatment faster.
“Our study supports that the 3HP treatment regimen for latent TB infection is safe for most patients,” she said. “Physicians and patients should be aware of common ‘flu-like’ symptoms that may occur, especially in the first month of treatment, and know that these symptoms will likely resolve.”
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