Researchers comparing dolutegravir to efavirenz suggest dolutegravir increases viral suppression and has similar rates of adverse events.

A new study has found that dolutegravir is the optimal medication for first-line treatment for people newly diagnosed with HIV. This discovery could change international treatment recommendations for newly diagnosed HIV patients, an update that could affect nearly two million people per year worldwide.

The study published in EClinicalMedicine was commissioned by the World Health Organization (WHO) as part of a planned update to its guidelines for HIV antiretroviral treatment (ART).

“Research supporting the 2016 WHO guidelines suggested that dolutegravir was effective and well tolerated, but its efficacy and safety among key populations, such as pregnant women and people living with both HIV and tuberculosis (TB), remained unclear,” said the study’s lead author, Dr Steve Kanters, who completed the research as a PhD candidate in University of British Columbia’s School of Population and Public Health (SPPH). “In 2018, new research warned of a potentially serious increase in risk of neural tube defects in the children of women who became pregnant while taking this treatment.”

According to the researchers, this risk meant that despite its favourable profile compared to other drugs, dolutegravir was only recommended as an alternative, with the antiretroviral efavirenz recommended as the primary treatment.

The study team completed a network meta-analysis of research stemming from 68 available antiretroviral therapy (ART) clinical trials. They found dolutegravir was superior to efavirenz in most outcomes, including viral suppression, tolerability and safety. Kanters commented that the five percent increase in the probability of viral suppression with dolutegravir could have a significant impact on achieving international goals for HIV treatment.

According to the researchers, another key attribute of dolutegravir is that it is effective in people who are resistant to NNRTI-class antiretrovirals (including efavirenz), a problem that is becoming increasingly common.

The analysis also showed that dolutegravir and efavirenz had similar rates of adverse events for pregnant women. The report stated that the increased risk of neural tube defects for dolutegravir was estimated to be less than 0.3 percent, which Kanters said shows “that the risk with dolutegravir is much more tolerable than previously thought and should quell the initial worry about this drug”.

“Dolutegravir appears to be here to stay as the preferred treatment for people newly diagnosed with HIV. However, it is important to recognise the good that efavirenz has done over the past two decades, as it helped lead the ART scale-up around the world,” added Kanters.

While this study is specifically focused on the optimal treatment for people newly diagnosed with HIV, an upcoming publication will review the evidence in support of switching to dolutegravir for people whose first treatment choice has been unsuccessful in controlling their HIV infection. This recommendation could mean improved treatment for the many people living with HIV around the world who are unable to achieve viral suppression despite being on treatment.

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Hard-to-reach populations living with HIV are 45% less likely to achieve optimal antiretroviral treatment (ART) adherence when compared to the general population of people living with HIV, reveals a new study.

In a meta-analysis, researchers sought to understand the association between ART adherence and being part of a socially excluded population – known as ‘hard-to-reach’ in public health. The analysis also  quantifies the gap in ART adherence when compared to socially included populations.

Hard-to-reach populations and sub-populations are considered difficult to engage or interact with due to their behaviours, identities, or characteristics that are associated with stigmatisation and discrimination – often leading to social exclusion. For the purpose of this study, these included sex workers, homeless populations and people who use drugs, all of whom are generally ignored by the public.

Hard-to-reach populations are well known to experience exclusion from health services and severe health inequalities, exacerbated by certain behaviours that put them at greater risk of HIV, including substance abuse, sex without a condom, transactional sex, and multiple sexual partners. As such, HIV prevalence in these groups is much higher than the general population.

Some studies suggest the rate of ART adherence in these groups to be extremely low, in homeless people living with HIV ART adherences ranges from 51% to 89%. Among female sex workers living with HIV in low- and middle-income countries, ART adherence is 76%, and among people who use drugs living with HIV, overall adherence is 60%. But a pooled systematic review of the association between being hard-to-reach and ART adherence had not previously been undertaken.

This meta-analysis pulled an initial 593 global records for full-text review, with 29 studies eventually eligible for inclusion. These included 16 cohort studies and 13 cross-sectional studies performed between 1993 and 2017 and reporting data between 1999 and 2018.

Just over half (52%) of the studies were from the United States and a quarter (24%) originated in Canada, while most (90%) investigated the association between drug use and ART adherence. Most studies measured adherence using self-reported questionnaires (n = 21, 72%), seven studies used pharmacy refills, and only one study used the self-reporting plus pill count method.

While there was significant variation between the studies, they found a 45% lower likelihood of optimal adherence among hard-to-reach populations – equal to a pooled odds of 0.55 when compared to the general population of people living with HIV.

The investigators also ran a regression model and sensitivity analysis accounting for any bias of study design, adherence threshold/cut-off point, adherence measure, region/country, observational period, and quality assessment results. Despite numerous analyses, they found these factors did not impact the results in any way.  

While the study was not designed to investigate exactly why adherence is lower in hard-to-reach individuals, in their discussion they note the complications of service delivery for this group which is not the result of any single factor. Other research has suggested inconsistent and chaotic lifestyles affect drug-users consistent access to care, while sex workers and people who use drugs may also be challenged by criminalisation, stigma and unsupportive healthcare settings created by ignorance and prejudice, to name a few.     

Results from studies among homeless populations reveal that coexisting problems of limited access to healthcare, an elevated risk of mental health problems, and worse attitudes toward treatment are associated with an increased likelihood of worse adherence.

In their conclusion, the authors commented that suboptimal ART could lead to poorer health outcomes in this group who already face stark health outcomes, such as clinical failure, the emergence of viral resistance and, subsequently, the potential for on-going HIV transmissions and outbreaks.

“Our findings regarding ART adherence by hard-to-reach people who suffer from extreme health inequities have implications for public health and medical service provision. Developing strategies and policies to address these inequities is essential for providing sustainable assistance and support.”

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