Label updated by PDMA in Japan, for ViiV’s 4 HIV products to change caution for patients with renal dysfunction

The four drugs subject to the label revisions are: 1) Epzicom Combination Tablets (abacavir + lamivudine), 2) Combivir Combination Tablets (zidovudine + lamivudine) 3) Dovato Combination Tablets (dolutegravir + lamivudine), and 4) Triumeq Combination Tablets (dolutegravir + abacavir + lamivudine).For all of these drugs, revisions were made to the description of targeted patients with renal dysfunction requiring dose adjustments from those with a “creatinine clearance (Ccr) level of 50 mL/min or lower” to those with a “Ccr level of 30 mL/min or lower.”

Meanwhile, patients with renal dysfunction subject to the caution in the updated labels are those with a “Ccr level of between 30 and 49 mL/min,” a change from a “Ccr level of 50 mL/min or lower” here as well. Along with this, the labels will also add the wording to the effect that a dose adjustment should be considered, if any lamivudine-associated side effects are suspected. The latest label updates follows overseas results from a post-marketing clinical trial, entitled DART, in antiretroviral naïve HIV patients. The revisions were deemed appropriate through the PMDA’s consultation meeting requested by the company.