First two-drug pill approved for new HIV treatment starters

15 April 2019

Treatment- naïve people living with HIV now have drug-sparing antiretroviral treatment options with new once-daily, two-drug, fixed-dose treatment, Dovato.

Pack of pills

Last week (8th of April) the Food and Drug Administration (FDA) – the US medicines regulatory body –approved the first complete HIV treatment regime containing only two antiretroviral drugs. This move will make the treatment available for people starting first-line antiretroviral treatment.

The drug, Dovato, is marketed by ViiV Healthcare and contains the integrase inhibitor, dolutegravir, (DTG) and the nucleoside reverse transcriptase inhibitor, lamivudine (3TC).

The marketing approval means that treatment-naïve individuals can benefit from a highly effective regime with fewer component drugs, reducing their lifetime cumulative exposure to different drugs and potential long-term toxicities. Every antiretroviral drug is associated with specific adverse events or other challenges to tolerability and adherence to therapy – so minimising these where possible is critical to successful long-term treatment, and as many people age with HIV and stay longer on treatment.  

The approval follows the successful completion of two multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. The trials were conducted in 192 centres across 21 countries over one year and found Dovato to be non-inferior to a once-daily, three-drug regime of dolutegravir plus tenofovir disoproxil fumarate (TDF) and emtricitabine.

Dovato comes with one warning for people co-infected with hepatitis B, given the reported resistance to lamivudine for this population. They also indicate that women wishing to conceive should avoid using Dovato at around the time of conception, given the reported dolutegravir-associated toxicities for the embryo.

Since 1996, effective HIV treatment regimens have consisted of at least three antiretroviral drugs, the combination of which has dramatically improved prospects for people living with HIV because it slowed down the development of drug-resistant mutations. But newer antiretroviral drug classes, and antiretroviral drugs have ushered in a new-era for HIV treatment. No treatment-emergent resistance occurred in the GEMINI trials.

Just one other fixed-dose, two-drug regime has been approved for use by the FDA, the ViiV Healthcare drug, Juluca (dolutegravir/rilpivirine). But this drug is only prescribed for people on ‘maintenance therapy’, meaning those who have already achieved viral suppression.

One other supposed benefit of two-drug regimes is that, in theory, two drugs instead of three should make the single-tablet cheaper. But Juluca was not much cheaper than any other three-drug formulations on the market at the time. In the USA, it was priced at $2,579 per month while other three-drug regimens were priced from $2,600 to $3,500 per month.

ViiV have priced Dovato at $2,295 in the USA, which equates to slightly more than the combined price of generic DTG and generic 3TC (which is available in the USA) at $2,240. Some, such as Tim Horn, chair of the Fair Pricing Coalition, welcomed the news, "the WAC [wholesale acquisition cost] price of $27,540 set for Dovato ushers in some much-needed sanity in drug pricing for highly effective, well-tolerated, and easy-to-take HIV treatment."

But others, such as Andrew Hill, M.D., a pharmacology expert at the University of Liverpool in the United Kingdom, have a different take.

"There was no improvement in either efficacy or safety for Dovato in the GEMINI trials," he told the Body. "So why should the price be so high? People could take generic TDF, 3TC, and a third drug for a much lower price."

Regardless of the cost battles, others welcome innovation in treatment regimes. Jeff Berry, Test Positive Aware Network (TPAN), said: “The approval of Dovato is a welcome paradigm shift, as it brings an innovative treatment approach to newly diagnosed adults with HIV-1. By exposing patients to fewer drugs at the start of treatment, the hope is to help address concerns arising from overall management of prolonged ARV [antiretroviral] therapy.” 

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Written by Caitlin Mahon

Content Specialist - HIV & Sexual Health