First two-drug combination pill for HIV treatment.

HIV treatment usually involves pills containing two inhibitors with important functions

Before this landmark development, it was impossible for people living with HIV to cover all of their needs through a single pill. ViiV Healthcare recently introduced a new treatment option after successful trials.

One pill contains Integrase inhibitors

Integrase inhibitors (INIs) are a type of  ARVs designed to block the function of integrase (a viral enzyme). Integrase is what inserts the HIV viral genome into host cells. Because this function is vital for HIV to replicate itself, blocking it halts further spread of the virus.

The other pill contains Nucleoside Reverse Transcriptase inhibitors

Nucleoside Reverse Transcriptase Inhibitors (NRTIs) were the first drugs available to treat HIV. Instead of inhibiting integrase, though, NRTIs inhibit something called reverse transcriptase. HIV cells heavily depend on reverse transcriptase for replication as well. Without this, the virus can’t copy itself at all.

‘Dovato’ – the new pill – now contains both inhibitors together

‘Dovato’, a new single-tablet antiretroviral regimen, now covers both functions. Manufacturer, ViiV Healthcare, is confident that this once-daily treatment application will help maintain a low viral load. ViiV is making it clear, though, that despite the medical revolution involved, this is not first-line therapy.

Are ‘Dovato’ pills safe to use?

More than 1400 participants were involved in studies and trials, resulting in approval being granted by the FDA. For surety, effects of traditional ARVs were included to compare against those only using ‘Dovato’. During 2018’s International AIDS Conference, reports surfaced that 91% of Dovato patients displayed an undetectable viral load. This means that the patients’ HIV RNA, at 48 weeks in, couldn’t be seen in any tests whatsoever. Alarmingly, the response rates for patients with both high and low viral load were identical.

Both regimens were safe and well-tolerated. Fewer side effects were seen among ‘Dovato’ patients. Traditional ARVS still seemed to induce headaches, diarrhoea, nausea, insomnia and fatigue.

‘Dovato’ patients also displayed reduced signs of kidney- and osteo-related degeneration. ‘Dovato’ comes with clear warnings, like the fact that HIV patients using it while coping with Hepatitis B could develop drug resistance. Lamivudine, a key ingredient, acts against both viruses. This opens the door for a genetic mutation to occur, and likely cause drug-resistant HBV, just like when you don’t adhere to a TB treatment plan. Drug-resistant mutations worsen liver inflammation if treatment adherence doesn’t occur. HIV/HBV co-infection patients should consider adding HBV treatment or choosing an alternative HIV regimen.

Is the pill safe to use while pregnant?

For pregnant women undergoing PMTCT treatment plans, ‘Dovato’ is not recommended. Trials presented an association with neural tube defects in newborns to women using ‘Dovato’ in their first trimester. ‘Dovato’ should not be used at the time of conception through the first trimester of pregnancy, according to the FDA.

Despite these restrictions, ‘Dovato’ offers a safe, easy-to-use option for HIV patients.

Key benefit

HIV patients now have the option of taking a two-drug regimen in a single tablet. This eliminates additional toxicity and potential drug interactions from other ingredients.

Sources:

Highleyman, L. 2019. US regulators approve new two-drug combination pill for HIV. AIDSmap. 11 April. Available at: http://www.aidsmap.com/news/apr-2019/us-regulators-approve-new-two-drug-combination-pill-hiv [Accessed 30 July 2019].

US Department of Veterans Affairs. 2018. Nucleoside reverse transcriptase inhibitors (NRTIs or nukes). 9 February. Available at: https://www.hiv.va.gov/patient/treat/nrtis.asp [Accessed 30 July 2019].

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