Short Regimen For TB Found To Be Safe With New First-Line HIV Drug

In what is being called by supporters as an “important moment” for tuberculosis (TB) control, a new study found that “a shorter regimen to prevent TB can be safely co-administered with dolutegravir (DTG)—the first-line drug to treat HIV in many high-burden TB countries,” according to a release.

The study was presented yesterday at the Conference on Retroviruses and Opportunistic Infections (CROI). The full press release is available here.

It found that: “weekly administration of rifapentine and isoniazid (3HP) for three months in adults with HIV taking DTG was well-tolerated, with no need for dose-adjustment. The findings put to rest fears of potential drug interactions with DTG and pave the way for scale-up of the 3HP regimen in 12 high-burden TB countries across three continents.”

According to the release: “The study, funded by Unitaid and carried out in South Africa by the Aurum Institute and the Johns Hopkins University Center for TB Research, looked at the safety and pharmacokinetics of giving 3HP with DTG. Researchers enrolled 60 adults with HIV, who received DTG for eight weeks, then began 3HP; after completion of 3HP, all participants were followed for four more weeks. Overall, co-administration of DTG and 3HP was well-tolerated.”

Next Steps

Next steps were identified in the release: “Based on today’s results, Aurum, through the Unitaid-funded IMPAACT4TB project, is moving ahead with the introduction of 3HP in 12 high-burden countries: Brazil, Ghana, Ethiopia, Kenya, Tanzania, Malawi, Zimbabwe, Mozambique, South Africa, India, Cambodia and Indonesia. Together, these countries represent 50 percent of the global TB burden. The project will prioritize 3HP for people living with HIV and children under five, and subsequently all those in close contact with TB patients.

3HP is already approved for the treatment of TB infection by the US Food and Drug Administration and is recommended by the US Centers for Disease Control and Prevention. The Aurum Institute and its partners will also be pursuing regulatory approval of 3HP products in project countries. In high-TB burden countries where rifapentine is not yet registered, an importation waiver to use rifapentine will be obtained through the Stop TB Partnership’s Global Drug Facility.

The results of this study will be shared with the WHO and project countries and the Aurum Institute will work closely with them so that the findings can be included into relevant treatment guidelines.”

 

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