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Partner Support Does Not Improve Second-Line Response in Randomized Trial
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CROI 2014, March 3-6, 2014, Boston
Mark Mascolini
Training partners (spouses, parents, or friends) to promote antiretroviral adherence did not improve 24- or 48-week virologic response to second-line antiretroviral therapy (ART) in a 9-site randomized trial run by the AIDS Clinical Trials Group (ACTG) [1]. Factors related to the trial design and other variables, the researchers surmised, could contribute to the lack of a significant difference in second-line response.
Some ART programs require treated people to identify a partner who can help with adherence, but research has not confirmed the value of this approach, ACTG investigators noted. To learn more about the impact of partner-based modified directly observed therapy (mDOT), the ACTG A5234 team planned this randomized trial of people switching from a failing first-line regimen at 9 sites in low- and middle-income countries.
Study participants had confirmed virologic failure (a viral load above 1000 copies) while taking a first-line regimen including a nonnucleoside and two nucleosides. Everyone began a second-line regimen consisting of twice-daily lopinavir/ritonavir and once-daily tenofovir/emtricitabine. All study participants identified an adherence partner among family members or friends.
The trial took place in Brazil, Botswana, Haiti, Peru, South Africa, Uganda, Zambia, and Zimbabwe. Participants randomized to the mDOT arm picked an adherence support partner and had a 1.5-hour training session with that partner. The session covered adherence support strategies and when and how to contact the study site for help. Support partners were instructed to observe and document one antiretroviral dose daily for more than 5 days per week for 24 weeks. In the control arm, participants and support partners received only general HIV health information. The primary outcome was the proportion of confirmed virologic failures (viral load above 400 copies) by week 48.
Among 129 participants assigned to mDOT, 119 completed follow-up; 119 of 128 assigned to standard care completed follow-up. Median age stood at 38 in the mDOT group and 37 in the control arm; respective proportions of women were 48% and 51% and of blacks 78% and 80%. Median prior ART duration stood at 153 weeks in the mDOT arm and 144 weeks in the control arm. Median CD4 count and viral load at study entry were 122 and 4.2 log (about 16,000 copies) in the mDOT group and 109 and 4.2 log in the standard-care group.
At week 24 the virologic failure rate was nonsignificantly higher in the mDOT group (19% versus 13%, P = 0.31). At week 48 virologic failure rates were 26% in the mDOT arm and 18% in the control arm, also a nonsignificant difference (P = 0.13). Adherence determined by electronic pill bottle caps was 90% or higher at each of four measures in both the mDOT arm and the control arm.
The researchers concluded that, with a high rate of virologic suppression in both study arms, mDOT had no significant impact on virologic suppression with second-line therapy. They suggested several reasons why the adherence intervention had no impact: (1) Control partners may have provided sufficient support without specific training. (2) A single instruction session may not be enough to enhance support skills. (3) Study visits may have provided enough adherence support in the control arm. (4) People who enroll in clinical trials may already be highly motivated to adhere to treatment.
Whether partner support would improve adherence in high-income countries remains unknown. As the ACTG team noted, several studies found better overall antiretroviral adherence in developing countries than in developed countries, which may thus benefit more from partner support. Or the strategy may have some impact if targeted to people with a poor adherence history.
Reference
1. Gross R, Zheng L, La Rosa A, et al. Partner-based intervention for adherence to second-line ART: a multinational trial (ACTG A5234). CROI 2014. Conference on Retroviruses and Opportunistic Infections. March 3-6, 2014. Boston. Abstract 538.
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