Huge blow to Gilead’s and Merck’s HIV strategy as safety concerns mar once-weekly HIV drug combination

USA – Gilead Sciences, Inc. and Merck have temporarily suspended enrollment in a Phase 2 clinical study evaluating an investigational once-weekly oral combination treatment regimen of islatravir and lenacapavir as combination treatment  in HIV patients.

The decision comes less than a week after Merck revealed that dosing in a separate study evaluating its drug, islatravir, in combination with another therapy known as MK-8507, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) had been halted.

The study recently discovered that patients who received the drugs had lower levels of certain types of white blood cells, especially when taking high doses of Merck’s MK-8507.

Subsequently, Merck and Gilead have decided to postpone adding more patients to their trial while they consider making changes to it due to an “abundance of caution.”

The companies stated that they remain optimistic about the combination of islatravir and Gilead’s medicine, known as lenacapavir, and that participants who have already enrolled will continue to receive the drugs. They will also be monitored in accordance with the current protocol.

Meanwhile ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc has scored another milestone after it’s US FDA-approved injectable antiviral CABENUVA received UK’s approval this week.

Cabenuva is a complete prescription regimen used to treat HIV-1 infection in adults as a replacement for their current HIV-1 treatment when their healthcare provider determines that they meet certain requirements.

The injection will benefit around 13,000 HIV-positive persons in the UK who will be eligible for the injection through the NHS, which has been hailed as “great news” by organizations who claim it would make treatment more convenient.

Many HIV patients can keep their infection at very low levels by taking one to four antiviral tablets every day, allowing them to live a near-normal life.

People with HIV are currently able to keep the infection at bay by taking antiretroviral medications on a regular basis. The virus is pushed to such a low level in these tablets that it maintains HIV patients strong and healthy and prevents them from passing the illness on to others.

Patients who choose the new treatment will receive two injections every one to two months, rather than taking tablets every day as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed.

Cabenuva is the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults, and with this new treatment countries can hope to eliminate HIV transmission in the near future.

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