Johnson & Johnson's Experimental HIV Drug Shows Promise with Fewer Side Effects
Johnson & Johnson's experimental HIV drug, rilpivirine or TMC278, has shown promising results in two pivotal trials, finding it works as well as an existing drug, but with fewer side effects. However, the data also reveals that nearly twice as many patients failed to respond to treatment. The drug is being developed for use in combination therapy for treating HIV, and Johnson & Johnson already has a deal with Gilead Sciences to develop a single pill combining rilpivirine with Truvada.
Key Takeaways:
- A combined analysis of two trials found that 84.3% of HIV patients treated with TMC278 and Truvada achieved undetectable levels of the virus, compared to 82.3% of patients treated with Atripla or similar drugs.
- Serious side effects, including psychiatric and neurological problems, were seen in 16% of the TMC278 group versus 31% of the Sustiva group.
- However, the data also showed 9% of TMC278 patients experienced virologic failure compared to 4.8% of Sustiva-treated patients.
- Johnson & Johnson has a deal with Gilead Sciences to develop a single pill combining rilpivirine with Truvada.
- Gilead would keep up to 30% of TMC278 sales under the deal.
- TMC278 is a non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS.
- The drug is being developed in combination with Truvada, a drug containing Gilead's tenofovir and emtricitabine.
Statistics:
- 84.3% of HIV patients treated with TMC278 and Truvada achieved undetectable levels of the virus.
- 82.3% of patients treated with Atripla or similar drugs achieved undetectable levels of the virus.
- 16% of the TMC278 group experienced serious side effects.
- 31% of the Sustiva group experienced serious side effects.
- 9% of TMC278 patients experienced virologic failure.
- 4.8% of Sustiva-treated patients experienced virologic failure.
- The TMC278 studies will last a total of 104 weeks.
- The researchers plan to submit the 48-week findings to US regulators in an application seeking approval of the drug as a treatment for previously untreated HIV patients.
Sources:
- Johnson & Johnson
- Gilead Sciences
- Bristol-Myers Squibb
- GlaxoSmithKline
- Shionogi
- Merck & Co
- The New York Times