Epivir HBV and Larotrectinib Sulfate

• Generic Name: lamivudine
• Dosage Forms: tablet, film coated and oral solution
• Other Brand Names: Epivir, Epivir HBV

Epivir HBV is an antiviral medicine that prevents human immunodeficiency virus (HIV) or hepatitis B virus from multiplying in your body.

Epivir is for treating HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Epivir is not a cure for HIV or AIDS.

Epivir-HBV is for treating hepatitis B. Epivir-HBV should not be used in people who are infected with both hepatitis B and HIV.

Epivir HBV may also be used for purposes not listed in this medication guide.

• Generic Name: larotrectinib
• Dosage Forms: n.a.
• Other Brand Names: Vitrakvi

Treatment of solid tumors harboring an NTRK fusion (without a known acquired mutation for resistance) in patients who have metastatic disease or may experience severe morbidity following surgical resection and whose disease progressed following prior therapy or those who are not candidates for other treatment options (designated an orphan drug by FDA for these cancers).

Accelerated approval based on overall response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

Confirmation of the presence of NTRK fusion is necessary prior to initiation of therapy. In clinical studies, NTRK fusion status of tumor specimens was determined by fluorescence in situ hybridization (FISH), reverse transcription-polymerase chain reaction (RT-PCR), or next-generation sequencing (NGS).