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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The Union Health Ministry has planned to introduce a new drug for the treatment of patients suffering from HIV/AIDS. “Dolutegravir” is a new drug which is likely to be available in the market by February 2020. Dr Naresh Goel, Deputy Director-General of National AIDS Control Organization (NACO) said in an interview: “Previously, we have been using the combination drug of TLE. But now, the health ministry has decided to use TLD combination drug – known as Dolutegravir. It has fewer side effects and tolerance is better.”

Informing about the other advantages of Dolutegravir drug, the official said that the resistance to the new drug will develop late and adherence is better. “The viral suppression is faster with the use of this new drug. We have started training our doctors on how to prescribe the new drug to the patients. By January, it will be done and in February, we will launch the drug,” he added.

Nearly eight in every 10 persons living with HIV are under treatment, according to the government data, and efforts are underway to expand the coverage basket. The Ministry of Health recently reiterated its resolve to make India HIV/AIDS free by 2030 with stress on zero infections by then.

The National AIDS Control Organisation statistics for 2017-2018 show 79 per cent people living with HIV know their status which makes it easier to seek treatment. “Post treatment, around 79 per cent people have their viral load suppressed. We are on the right track to ridding India of HIV,” Health Minister Harsh Vardhan said.

As of now the current estimates of People Living with HIV (PLHIV) is about 2.14 million, said the official. The health ministry has set the target to achieve the target of Sustainable Development Goal (SDG) by eliminating the epidemic of HIV/AIDS from India by 2030.

According to Union Health Minister Dr Harsh Vardhan, “During 2018-19, about 79 per cent people living with HIV knew their status and 82 per cent diagnosed with HIV are receiving free antiretroviral therapy and 79 per cent are virally suppressed. The basic target remains that of ‘’Three Zeros’’ — i.e. zero new infections, zero AIDS-related deaths and zero discrimination.”

As per the official data by NACO, every year about 88,000 new infections are added to their list. NACO has strengthened its monitoring mechanism with more than 35,000 reporting units providing information on completely IT-enabled system. Since 1980s NACO is playing a key role in fighting against the disease and reducing the prevalence of HIV/AIDS in the country. It has signed MOU with 18 Central government ministries to combat the disease.

Treatment access remains a challenge with most patients finding it difficult to use anti-retro viral dispensing facilities. Treatment gap remains the big challenge for HIV control.

The ambitious goal of ending HIV by 2030 notwithstanding, as per the latest HIV estimates published by the National Aids Control Organisation, India has reported only marginal improvements in the fight against the epidemic between 2015 and now. In real terms, there has been a rise in AIDS-related deaths between 2015 and 2017 with 69,110 dying of the infection in 2017 as against 67,612 two years ago.

The number of people living with the infection has risen from 21.17 lakh in 2015 to 21.40 lakh now. HIV prevalence in adults has declined over the years and is now 0.22 per cent as against 0.28 per cent in 2015. Experts working in the HIV sector say new infections remain a challenge with 40 per cent being reported among women. As of 2015, there were 89,000 new HIV infections in India. This has marginally reduced to 87,000, showing the slow  progress in the area.

India has pledged to end the AIDS epidemic by 2030 by halting and reversing it and recently passed a law to ensure non-discrimination with people living with HIV. The apex court further aided the anti-HIV fight by reading down Section 377 of the IPC which criminalised same sex relationship between consenting adults. The section was leading to HIV burden among men having sex with men going unreported as the patients went underground for fear of punishment.

Regional scenario

India, China and Pakistan are among the 10 countries that accounted for more than 95 per cent of all new HIV infections in the Asia and the Pacific region in 2016, according to a UN report. Scales have tipped for the first time in the fight against AIDS as more than half of all people living with the HIV virus now have access to treatment, while AIDS-related deaths have nearly halved since 2005, said the report by the Joint UN Programme on HIV/AIDS, UNAIDS, ‘Ending AIDS: Progress towards the 90?-90-90 targets’.

In the Asia and the Pacific region, the majority of new infections are occurring in 10 countries led by India, China, Indonesia, Pakistan, Vietmnam, Myanmar, Papua New Guinea, the Philippines, Thailand and Malaysia.

These 10 countries together accounted for more than 95 per cent of all new HIV infections in the region in 2016. The report gives a comprehensive analysis of the 2014 targets to accelerate progress so that by 2020, 90 per cent of all HIV-infected people know their status, 90 per cent of all HIV-diagnosed people are accessing antiretroviral therapy (ART) and 90 per cent of those taking ART are virally suppressed.

The region’s HIV epidemic remains largely concentrated among key populations, including sex workers and their clients, gay men and other men who have sex with men, people who inject drugs, and transgender people. The annual number of new HIV infections in Asia and the Pacific has declined 13 per cent over the last six years, from 310,000 in 2010 to 270,000 in 2016.

The report added that in India, a respondent-driven sampling survey across 26 cities found that knowledge of HIV status was 41 per cent among people living with HIV who inject drugs. Of those who knew their HIV status, only 52 per cent were accessing antiretroviral therapy and 83 per cent of those accessing treatment were virally suppressed (55).

Among gay men and other men who have sex with men living with HIV who also were surveyed, 30 per cent knew their HIV status, 68 per cent of those who knew their HIV status were accessing treatment, and 78 per cent of those on treatment were virally suppressed.

The report added that last year, 19.5 million of the 36.7 million people living with HIV globally had access to treatment and AIDS-related deaths have fallen from 1.9 million in 2005 to one million. With continued scale-up, this progress puts the world on track to reach the global target of 30 million people on treatment by 2020, according to the report. “We met the 2015 target of 15 million people on treatment and we are on track to double that number to 30 million and meet the 2020 target,” said UNAIDS Executive Director Michel Sidib. “We will continue to scale up to reach everyone in need and honour our commitment of leaving no one behind.”

Eastern and southern Africa, which account for more than half of all people living with the virus, are leading the way. Since 2010, AIDS-related deaths there have declined by 42 per cent and new HIV infections by 29 per cent, including a 56 per cent drop in new infections among children over that period. The report described it as a remarkable achievement of HIV treatment and prevention efforts aimed at putting the region on track towards ending epidemic.

In contrast, progress against the targets has been poor in the Middle East, North Africa, Eastern Europe and Central Asia, where AIDS-related deaths have pointedly risen. Exceptions, however, include Algeria, Morocco and Belarus, which have increased HIV treatment access from 2010 to 2016. The report also shows that globally, 30 per cent of people living with HIV still do not know their status, 17.1 million are unable to access ART and more than half are not virally suppressed.

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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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