Discover the key headlines from the 10th International AIDS Society Conference on HIV Science (IAS 2019; 21–24 July 2019, Mexico City, Mexico), the largest open scientific conference on HIV science globally, boasting over 90 sessions from workshops to symposia.
- WHO recommends dolutegravir as preferred HIV treatment option for all populations
- Babies born to women on dolutegravir have higher risk of neural tube defects
- Positive data presented for fostemsavir in heavily treatment-experienced patients
- Merck presents 48-week data from Phase IIb study evaluating anti-HIV agent MK-8591
- ‘Undetectable = Untransmissible’: huge growth in the campaign over past 3 years
- Combined HIV prevention strategy reaches more people but has similar viral suppression as standard-of-care
- WHO release report on HIV drug resistance
WHO recommends dolutegravir as preferred HIV treatment option for all populations
Based on evidence assessing risks and benefits the WHO has announced at IAS 2019 that dolutegravir should be the preferred first- and second-line treatment option for all populations, including pregnant women.
Despite studies suggesting a link between dolutegravir and neural tube defects in children born to women taking the drug at conception, which had previously led to pregnant women being advised to take efavirenz instead, new data from two clinical trials comparing dolutegravir with efavirenz has provided more evidence. From these trials, dolutegravir is suggested to be a more effective drug that is easier to take and that has fewer side effects, with the risk of neural defects perhaps being lower than initially thought. Moreover, dolutegravir has a high genetic barrier to developing drug resistance, all of which played into new guidelines.
However, the WHO stresses that women should make an informed choice and monitoring of the association between dolutegravir and neural tube defects should continue.
Babies born to women on dolutegravir have higher risk of neural tube defects
Infants born to women on antiretroviral therapy containing dolutegravir have higher risk of neural tube defects, compared with other drug regimens, according to research presented at IAS 2019. The study had tracked birth outcomes for children born to women on antiretroviral therapy in eight hospitals in Botswana since 2014.
In 2018 a preliminary analysis suggested that mothers receiving dolutegravir at conception potentially had a higher risk of their babies having neural tube defects, and the full results have now been presented, suggesting that neural tube defects occur in 0.3% of women on dolutegravir, compared with 0.1% in women on other regimens.
Positive data presented for fostemsavir in heavily treatment-experienced patients
Week 96 data for the BRIGHTE study, a two-cohort (randomized and non-randomized), Phase III trial evaluating the safety and efficacy of the attachment inhibitor fostemsavir in heavily treatment-experienced adults with HIV-1 infection, has been presented at IAS 2019. The results from the randomized cohort indicated that virological suppression and the immunological response increased between week 48 and week 96, suggesting this first-in-class drug could present a new treatment avenue for this hard-to-treat patient group.
Kimberly Smith, Head of Global Research & Medical Strategy at ViiV Healthcare (Brentford, UK), commented: ““People living with HIV who are heavily treatment-experienced have few options available to them due to the complexities of resistance, safety, tolerability, contraindications and prior treatment failure […] and the findings from BRIGHTE reinforce fostemsavir as a potential treatment option for these individuals.”
ViiV Healthcare plans to submit regulatory applications for fostemsavir with the US FDA later this year.
Merck presents 48-week data from Phase IIb study evaluating anti-HIV agent MK-8591
Merck (NJ, USA) has presented a series of abstracts at IAS 2091 demonstrating data on its anti-HIV agent MK-8591. The results include findings from the first-in-human-trial of MK-8591-eluting implants, suggesting that the concentrations achieved could be suitable for HIV prophylaxis. Moreover, 48-week data from a Phase IIb study evaluating MK-8591 in combination with doravirine has suggested that this combination therapy establishes and maintains viral suppression in treatment-naïve adults with HIV-1 infection.
PrEP use wanes after 3 months in young women
An open-label Phase IV study of Truvuda for HIV pre-exposure prophylaxis (PrEP) has assessed 427 young African women, discovering that 95% of individuals began PrEP but at 3 months only 84% of the 371 participants who returned for follow-up had deteclable levels of the drug in their system. At 6 months and 12 months these levels fell to 57% and 31% respectively, with only 9% of women having blood levels that indicated ‘high adherence’ at 12 months.
Connie Celum, protocol chair of the trial, termed HPTN 082, commented: “Multiple efficacy studies have shown that taking PrEP consistently every day provides high levels of protection against the acquisition of HIV. Unfortunately, as with all routine medication–especially for prevention purposes–daily adherence can be a challenge. Our findings suggest that our participants initially adhered well to PrEP. We need to develop effective ways to support young African women who still desire PrEP after this initial period to maintain their adherence and optimize their protection.”
Trial suggests women want and will use dapivirine ring
Results from an open-label study of a vaginal ring, intended to be used for the duration of a month, found that a majority of women wanted the ring and were willing to use it to protect themselves against HIV. Findings from the HOPE study were reported at IAS 2019 suggested the ring, which releases dapivirine into the vagina during the month it is used, had no safety concerns and was accepted by 92% of women at the start of the study, waning to 79% at month nine.
Jared Baeten (University of Washington, WA, USA) explained: “We wanted women to know that the decision was theirs to make, and theirs alone. As it turns out, most participants wanted the dapivirine ring – they accepted the ring being offered. And women in HOPE also appeared to use the ring more consistently than they did in ASPIRE [a previous clinical trial].”
‘Undetectable = Untransmissible’: huge growth in the campaign over past 3 years
The Prevention Access Campaign (PAC) have announced at IAS 2019 that 886 organizations from almost 100 countries have joined the ‘Undetectable = Untransmissible (U=U)’ movement advocating for the dissemination of the widely unknown information that a person living with HIV who has an undetectable viral load cannot sexually transmit the virus.
In addition to this, PAC has called on global stakeholders to make new commitments, including increasing public health information.
“The scale and impact of the U=U community of activists is unprecedented for any global public health and human rights movement,” commented Bruce Richman, founder of PAC. “When we launched U=U, most international health bodies and advocacy organizations were not ready to publicly acknowledge it. Some persistently and aggressively fought us. Over the course of the past three years that has changed, reminding us of what is possible when passionate people join together to demand accurate and meaningful information about our social, sexual and reproductive health.”
Combined HIV prevention strategy reaches more people but has similar viral suppression as standard-of-care
The HPTN 078 trial was designed to compare the effectiveness of a combined HIV prevention strategy, including a peer-to-peer referral method to recruit men who have sex with men (MSM) living with unsuppressed HIV, to the standard-of-care. New results presented at IAS 2019 reported that after 1 year 91% of participants were retained in the follow-up, however, only 48% had achieved viral suppression. Moreover, the researchers noted that there was no difference in viral suppression between participants who received the case management intervention and those who received the standard-of-care.
Robert Remien, HPTN 078 protocol co-chair (Columbia University, NY, USA), commented: “These findings remove the idea that we cannot reach people who are currently not engaged into care. We were able to enroll 94% of eligible study participants. The data shows that the longer people were in the study, the more likely they were to be virally suppressed.”
WHO will release report on HIV drug resistance
The WHO have released a new report on HIV drug resistance across the globe at IAS 2019. They report that in 12 of the 18 countries that reported survey data between 2014 and 2018, levels of pretreatment resistance to efavirenz and nevirapine among adults initiating first-line antiretroviral therapies exceeded the WHO recommended threshold of 10%. Moreover, the report suggests that levels of pretreatment drug resistance are nearly twice as high in women when compared with men.
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