Based on new evidence assessing benefits and risks, the WHO recommends the use of the HIV drug dolutegravir (DTG) as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.  

Initial studies had highlighted a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to women using the drug at the time of conception. This potential safety concern was reported in May 2018 from a study in Botswana that found 4 cases of neural tube defects out of 426 women who became pregnant while taking DTG. Based on these preliminary findings, many countries advised pregnant women and women of childbearing potential to take efavirenz (EFV) instead.

New data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base. The risks of neural tube defects are significantly lower than what the initial studies may have suggested.

The guidelines group also considered mathematical models of the benefits and harms associated with the two drugs; the values and preferences of people living with HIV, as well as factors related to implementation of HIV programmes in different countries, and cost.

DTG is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used. DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to EFV and nevirapine-based regimens. In 2019, 12 out of 18 countries surveyed by WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%.

All of above findings informed the decision to update the 2019 guidelines.

In 2019, 82 low- and middle-income countries reported to be transitioning to DTG-based HIV treatment regimens. The new updated recommendations aim to help more countries improve their HIV policies.

As for any medications, informed choice is important. Every treatment decision needs to be based on an informed discussion with the health provider weighing the benefits and potential risks.

WHO also stresses the importance of providing information and options to help women make an informed choice. To this end WHO has convened an advisory group of women living with HIV from diverse backgrounds to advise on policy issues related to their health, including sexual and reproductive health. WHO highlights the need to continually monitor the risk of neural tube defects associated with DTG.

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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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