In an intervention for antiretroviral treatment (ART) and opioid use disorder (OUD) treatment, people with HIV who inject drugs were found to later experience a decline in viral suppression, which reflects a need for maintenance support, according to study results published in Open Forum Infectious Diseases.1

A team of investigators conducted a randomized, controlled vanguard study (HPTN 074; ClinicalTrials.gov Identifier: NCT02935296) to determine whether an integrated intervention with psychosocial counseling and supported referrals for ART and substance use treatment would reduce HIV transmission among injection partners.2

The initial study, which took place in Ukraine, Vietnam, and Indonesia, randomly assigned enrolled patients to in-country standard-of-care or a flexible integrated intervention.1 At 52 weeks of follow-up, the researchers found that participants in the intervention group were significantly more likely to have HIV viral suppression.


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In this nonrandomized extension of the trial, the investigators invited the index participants to re-enroll for up to an additional 52 weeks to determine whether longer-term treatment would affect treatment durability.

Of the 502 people with HIV who injected drugs who had enrolled in the original study (standard of care, n=376; integrated intervention, n=126), 327 participants were re-enrolled in the extension, which took place from September 4, 2017, to July 7, 2018. There were 89 participants in the intervention continuation group, 94 patients in the need-of-support group, and 144 patients who continued standard of care.

Among participants in the intervention-continuation group, 89% of people completed extension visits at week 13, and 88% of people completed extension visits at week 26. Extension visits for weeks 13 and 26 were completed by 99% and 94% of participants in the need-of-support group, respectively.

At re-enrollment, 75% of the participants in the intervention-continuation arm reported being on ART and 43% reported being on medication for an OUD. Among participants in the need-of- support group, 45% reported being ART naive or previously on ART, and 84% were not taking medication for an OUD.

Of the participants in the intervention-continuation group who were alive by the end of the study, the probability of being on ART decreased by 7.1%, and the probability of using medication for an OUD decreased by 3.6%. Viral suppression (<40 copies/mL) decreased from 41% at week 52 to 29% at week 104, with an approximately 9.4% decrease per year. 

Conversely, the number of participants in the need-of-support group who were alive and on ART increased from 55% at re-enrollment to 69% at week 26. Similarly, the use of medication for an OUD also increased in this study arm from 16% at enrollment to 25% at week 26. Viral suppression (<40 copies/mL) increased from 40% at re-enrollment to 49% at week 26.

“[T]he HPTN 074 extension showed waning durability of the intervention effects during the second year following enrollment in the primary trial, suggesting that [people who inject drugs] living with HIV need maintenance support with an emphasis on [medication for OUD] uptake and incorporating routine drug resistance testing, as an approach for sustaining viral suppression,” the authors noted.

Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please refer to the original reference for a full list of authors’ disclosures.

References

  1. Lancaster KE, Mollan KR, Hanscom BS, et al. Engaging people who inject drugs living with HIV in antiretroviral treatment and medication for opioid use disorders: extended follow-up of HPTN 074. Open Forum Infect Dis. Published online May 29, 2021. doi:10.1093/ofid/ofab281
  2. Integrated treatment and prevention for people who inject drugs. ClinicalTrials.gov identifier: NCT02935296. Updated December 24, 2018. Accessed June 9, 2021. https://clinicaltrials.gov/ct2/show/NCT02935296