Sex: M
Vaccine: HEP
Symptoms: Acute hepatitis B, Alanine aminotransferase increased, Analgesic drug level, Aspartate aminotransferase increased, Blood HIV RNA increased
Clinical narrative: The patient still developed an acute HBV infection; This serious case was reported in a literature article and described the occurrence of acute hepatitis b in a 30-year-old male patient who received Hepatitis B vaccine for prophylaxis. Literature Reference.   Co-suspect products included cabotegravir for hiv infection, rilpivirine hydrochloride (Rilpivirine) for hiv infection and cabotegravir, rilpivirine (Cabotegravir + Rilpivirine) suspension for injection for hiv infection.   The patient's past medical history included hospitalization, meningitis and condom. Previously administered products included efavirenz/emtricitabine/tenofovir with an associated reaction of no adverse event and bictegravir/emtricitabine/tenofovir alafenamide with an associated reaction of no adverse event. Concurrent medical conditions included hiv infection, acquired immunodeficiency syndrome, sexually transmitted disease (syphilis, chlamydia, and anal herpes papillomavirus), alcohol use, homosexual, cosmetic body piercing, syphilis, chlamydial infection and anorectal human papilloma virus infection. Concomitant products included atorvastatin, fenofibrate, bictegravir, emtricitabine and tenofovir alafenamide.   On an unknown date, the patient received Hepatitis B vaccine. In OCT-2023, the patient started cabotegravir (oral) and Rilpivirine (oral). In NOV-2023, the patient started Cabotegravir + Rilpivirine (injection). On an unknown date, an unknown time after receiving Hepatitis B vaccine and an unknown time after starting cabotegravir, Rilpivirine and Cabotegravir + Rilpivirine, the patient experienced acute hepatitis b (Verbatim: The patient still developed an acute HBV infection) (serious criteria hospitalization and GSK medically significant). Cabotegravir was discontinued (Dechallenge was positive). Rilpivirine was discontinued (Dechallenge was positive). Cabotegravir + Rilpivirine was discontinued (Dechallenge was positive). The outcome of the acute hepatitis b was resolving.   The reporter considered the acute hepatitis b to be possibly related to Hepatitis B vaccine. The reporter considered the acute hepatitis b to be related to cabotegravir, Rilpivirine and Cabotegravir + Rilpivirine. It was unknown if the reporter considered the acute hepatitis b to be related to cabotegravir + rilpivirine needle device, cabotegravir + rilpivirine syringe device and cabotegravir + rilpivirine vial adaptor device.     The company considered the acute hepatitis b to be unrelated to Hepatitis B vaccine, cabotegravir, Rilpivirine, Cabotegravir + Rilpivirine, cabotegravir + rilpivirine needle device, cabotegravir + rilpivirine syringe device and cabotegravir + rilpivirine vial adaptor device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 06-JAN-2025  Author reported a 30-year-old man with a history of HIV who presented due to elevated liver enzymes. The patient has sex with men and was diagnosed with HIV and acquired immunodeficiency syndrome in 2013, when he was hospitalized for meningitis. He was initiated on an efavirenz/emtricitabine/tenofovir combination and took it until 2019. In 2019, the patient was switched to a combination of bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF). The patient is known to have insertive and receptive sex with multiple partners with occasional condom use. He has a history of various sexually transmitted diseases (syphilis, chlamydia, and anal herpes papillomavirus). The patient was transitioned to cabotegravir/rilpivirine (CAB/RPV) on October 2023 from a B/FTC/TAF due to pill fatigue, despite 100 percent adherence. The patient was vaccinated for HBV before switching HIV medications. The patient was referred to the hospital. On presentation, the patient was asymptomatic and denied having fever, chills, scleral icterus, arthralgias, abdominal pain or tenderness, extremity swelling, and shortness of breath. The patient denied known sick contacts, recent travel, history of smoking, intravenous drug use, and sharing needles or razors. He consumed alcohol socially. He acknowledged having continued sexual encounters with multiple male partners and intermittent use of protection. The patient reported a recent piercing from a reputable piercing studio. Reported home medications were atorvastatin 10 mg and fenofibrate 48 mg, both taken daily. The LFTs were subsequently normalized. The patient's partner was scheduled to be screened for HBV. The patient was educated on HBV risks and transmission. Unlike the patient, however, anti-HBs levels were only checked after the patient tested positive for an acute HBV infection after CAB/ RPV initiation. The patient's anti-HBs levels confirmed immunity with a level greater than 10 mIU per mL (14 mIU per mL). Despite this, the patient still developed an acute HBV infection. It is important to note that the patient continued to participate in high-risk behavior after the switch to CAB/RPV. Though routine laboratory results were conducted monthly, HBV tests were not routinely done during follow-ups.  This article is not available for regulatory reporting purpose due to copyright restrictions.; Sender's Comments: Acute hepatitis B  is an unlisted event which is considered unrelated to GSK vaccine Hepatitis B vaccine and ViiV drug Cabotegravir, RILPIVIRINE HYDROCHLORIDE, Cabotegravir+ Rilpivirine , Cabotegravir + Rilpivirine NEEDLE DEVICE , Cabotegravir + Rilpivirine SYRINGE DEVICE , Cabotegravir + Rilpivirine VIAL ADAPTOR DEVICE.