Doravirine (Pifeltro): A Promising Treatment for HIV-1 Based on DRIVE Trial Results

The human immunodeficiency virus (HIV) is a virus that attacks and weakens the immune system, which leads to acquired immune deficiency syndrome (AIDS). This causes a person to be susceptible to various kinds of infections and diseases. In 2020, statistics recorded 37.7 million people living with the disease. There are 2 subtypes: HIV 1 and HIV 2. HIV-1 is more aggressive and responsible for the worldwide pandemic.


Pifeltro Credit:

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Currently, there is no cure. However, there are drugs called antiretroviral drugs that limit the spread of the virus by reducing its count or number in the body. Doravirine AKA Pifeltro is one of them. It is a class of antiretroviral drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs), which are usually combined with other anti-HIV drugs to treat HIV/AIDS.

Doravirine is safe and effective

Studies have revealed that antiretroviral therapy (ART) has significantly decreased the rate of AIDS-related disabilities and deaths worldwide. One of the newer members of this large family, doravirine was approved in 2018 by the FDA for treating HIV infection in adults.

Chloe Orkin and her colleagues wanted to find out how safe and effective Doravirine is for adult patients with HIV-1. They recruited 1,494 participants into two phase 3 trials called DRIVE-FORWARD and DRIVE-AHEAD.

They ensured the participants had never been on ART before, had at least 1000 copies of the virus in their blood, and had no resistance to any trial medications.

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Observed for 96 weeks until the 192nd week, people who just started taking the drug or switched from a previous regimen to doravirine experienced good lipid levels, minimal weight gain, and a negligible reduction in the rate at which the kidneys make urine. Also, no one stopped taking the drug due to toxicity or other adverse reactions.

Clinical significance

Doravirine has shown remarkable efficacy and safety so far, and if further observations produce favorable results, this could be the gold standard treatment option for HIV-1 infection. This could greatly improve the quality of life and reduce AIDS-induced disability and death.

It can be comfortably used as a long-term first-line therapy for newly diagnosed patients and those who have suppressed viruses in their blood.

Longer-term side effects of ARTs include kidney toxicity, liver toxicity, and abnormal fat deposits in the body, which can increase the risk of having a heart attack. This can be very disheartening. In practice, doravirine could have an advantage over other ARTs because of its better safety profile.

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Any day that new research unveils new antiretroviral drugs is a good day, especially for the millions living in Sub-Saharan Africa where the bulk of the HIV/AIDS disease is found. Perhaps one day we will discover a cure to the disease, putting an end to one of humanity’s greatest scourges once and for all.


Orkin, C., Molina, J.-M., Cahn, P., Lombaard, J., Supparatpinyo, K., Kumar, S., et al. (2023). Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials. The Lancet HIV.



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