Infectious Disease

4-month TB routine, which isn’t inferior to the 6-month routine in individuals with HIV

March 09, 2021

2 min read

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Pettit A et al. Abstract 130. Presented at: Conference on Retroviruses and Opportunistic Infections; 6-10 March 2021 (virtual meeting).

Disclosure:
Pettit does not report any relevant financial information.

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A 4-month daily regimen of rifapentine and moxifloxacin was not inferior to the standard 6-month regimen for tuberculosis treatment in people with HIV who were in a phase 3 clinical trial, researchers at CROI reported.

“Current international guidelines recommend 6 months of drug-sensitive pulmonary TB treatment with isoniazid, rifampicin, pyrazinamide and ethambutol.” April Pettit, MD, MPH, Associate professor of medicine at Vanderbilt University Medical Center, said Healio. “Shorter treatment regimens would enable better treatment adherence and reduce potentially adverse drug events and treatment costs. Rifapentine (RPT) and moxifloxacin (MOX) have shown promise for shortening TB treatment in mouse models. “

April Pettit

As part of the TB Trials Consortium Study 31, an international, randomized, open-label phase 3 non-inferiority study, Pettit and colleagues compared patients who received either of two 4-month RPT-based regimens or the 6-month control regimen. According to the study, one 4-month regimen replaced rifampin with RPT 1,200 mg (RPT regimen) and the other replaced both rifampin with RPT 1,200 mg and ethambutol with MOX 400 mg (RPT-MOX regimen). In addition, participants with HIV were enrolled on efavirenz (EFV) -based ART in a tiered manner to enable studies of drug interactions between RPT and EFV.

Pettit and colleagues took part in 2,516 participants from 13 countries in sub-Saharan Africa and Asia as well as from America. Of these participants, 214 (8%) had HIV and all had EFV-based ART at baseline or started within 8 weeks of registration.

The study showed that the overall efficacy of RPT-MOX was not inferior to control after adjusting HIV status and cavitation in the microbiologically eligible and assessable populations (absolute difference) [AD] = 1%; 95% CI, -2.6% to 4.5% and AD = 2%; 95% CI, -1.1% to 5.1%), the researchers said. Among the HIV participants, RPT-MOX was the control in the microbiologically eligible population (AD = –7.5%; 95% CI, –20.8% to 6.1%) and the assessable population (AD = – 6.6%; 95% CI, – not inferior to 18.3% to 5%) they found.

In addition, the researchers said that 91% of the participants in the RPT-MOX arm, 74% in the RPT arm, and 85% in the control arm identified a favorable outcome in the assessable analysis population with HIV infection. In addition, fewer serious or serious adverse events were reported in patients receiving the designs than in patients in the control arm.

“The rifapentine-moxifloxacin regimen is an important milestone in the search for shorter TB treatment plans for people living with HIV,” said Pettit.

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Gitanjali Pai, MD, AAHIVS, FIDSA)

Gitanjali Pai, MD

When it comes to compliance regardless of disease, shorter treatment regimens generally earn more patient approval. As we’ve seen with other microbial diseases (e.g., hepatitis C), shorter therapies are more attractive to patients, especially in a population that is already pill-loaded, such as our HIV population (although this has been improving a lot recently has been). A shorter duration of treatment for a very contagious, communicable disease like TB certainly appears to be more practical and practical, to reduce the burden on patients and, hopefully, result in a more convenient, compliant quick-in-quick-out treatment for TB as we continue to manage their long-term ART for HIV, both of which are and will remain important public health issues.

Gitanjali Pai, MD

Member of the editorial team for infectious diseases

Adjunct Clinical Assistant Professor of Rural Health – Internal Medicine / Infectious Diseases

Oklahoma State University

Infectious Disease Doctor

Memorial hospital and medical clinic

Stilwell, Oklahoma

Disclosure: Pai does not report any relevant financial information.

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Conference on Retroviruses and Opportunistic Infections (CROI)

Conference on Retroviruses and Opportunistic Infections (CROI)

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