May 5, 2017
This week, a study finds that a quarter of Kenyans with HIV who have experienced second-line treatment failure have multidrug-resistant HIV. Another study finds that bictegravir, an investigational integrase inhibitor, is just as effective as dolutegravir (Tivicay). And our last study finds that mailing consent forms ahead of time was more beneficial to study participants than simply rewording the form. To beat HIV, you have to follow the science!
A quarter of Kenyans whose second-line HIV treatment no longer works are resistant to all available first- and second-line antiretrovirals, a study published in AIDS showed.
Researchers tested plasma from 123 people whose second-line treatment no longer controlled their viral load. Almost two-thirds had at least one mutation that confers resistance to a nucleoside reverse transcriptase inhibitor (NRTI), close to a third had at least one major mutation that resists a protease inhibitor (PI), and almost a quarter showed resistance to all three most common classes of antiretrovirals: NRTIs, PIs and non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is unclear why two thirds showed no PI resistance, yet failed the PI-based second-line treatment.
Study authors hypothesize that this outcome might be related to not taking the medications at all or to mutations elsewhere in the virus. Third-line HIV medications recommended by the World Health Organization cost 6 to14 times as much as the drug classes used for first- and second-line therapy. "Sustainability is thus a challenge for [antiretroviral therapy] programs in low and middle-income countries," study authors noted.
Bictegravir, an experimental antiretroviral, showed similar efficacy as dolutegravir, an approved drug of the same class, in a small phase-2 trial funded by Gilead Sciences, the manufacturer of bictegravir. Study data were published in The Lancet.
Researchers selected 98 people living with HIV, all with viral loads of 1,000 copies/mL or more, and randomized them 2:1 to the study drugs -- twice as many participants received bictegravir than got dolutegravir. Everyone also took emtricitabine and tenofovir alafenamide (TAF). Twenty-four weeks into the study, viral loads had been suppressed to fewer than 50 copies/mL in 96.9% of those in the bictegravir arm and 93.9% of participants in the dolutegravir arm. More people in the bictegravir group (85%) reported negative side effects than did in the dolutegravir group (67%), mainly diarrhea and nausea.
Similar figures held for week 48, although one participant in the bictegravir arm discontinued the study because of a trial-related adverse event. Unlike dolutegravir, bictegravir does not require boosting. A potential single-tablet formulation with TAF is "likely to be very popular where cost is not a primary concern," Tristan Barber noted in a related comment.
Study participants understood equally well and were just as happy with standard consent forms compared to concise forms, a substudy of the START trial published in PLOS One found.
The concise version used simpler language and other best practices to reduce the reading level from 10th grade to 9th grade. START is a multi-country trial, and both forms were translated into various languages. Researchers therefore randomized 154 study sites in clusters by language to use either the standard or concise form. More than 4,000 people participated in this substudy.
After completing the form, questionnaires assessed participants' understanding of the form's content and satisfaction with the process. Responses to comprehension questions did not differ significantly between the concise and standard arms. Rather, questionnaire scores were associated with educational level, age, race and location.
Mailing the form in advance of the clinic visit also improved comprehension scores. Responses to the satisfaction survey were also very similar between the study arms. However, receiving educational information in addition to the form increased satisfaction with the process. "These findings suggest simple strategies that research teams could adopt to improve participant comprehension and satisfaction," study authors concluded.
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