An NRTI - It is used with other medicines to treat HIV
FDA Alerts
Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals. (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)
Epivir® tablets and oral solution (used to treat HIV infection) contain a higher dose of lamivudine than Epivir-HBV® tablets and oral solution (used to treat hepatitis B virus). Patients with HIV should receive only the dosage forms appropriate for treatment of HIV.
HIV counseling and testing should be offered to all patients prior to and during Epivir-HBV® therapy. Epivir-HBV® tablets and oral solution contain a lower dose of lamivudine than Epivir® tablets and oral solution. Use of Epivir-HBV® in patients with unrecognized or untreated HIV infection may result in rapid emergence of resistant HIV because the dose is subtherapeutic and monotherapy is inappropriate.
Severe acute exacerbations of hepatitis B virus (HBV) reported following discontinuance of lamivudine in patients coinfected with HBV and HIV. Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after lamivudine is discontinued in patients coinfected with HBV and HIV. If appropriate, initiation of treatment for HBV infection may be warranted.
The fixed-combination preparation Combivir® contains 2 NRTIs (lamivudine and zidovudine) the fixed-combination preparation Epzicom® contains 2 NRTIs (lamivudine and abacavir), and the fixed-combination preparation Trizivir® contains 3 NRTIs (abacavir, lamivudine, zidovudine); these are intended only for patients whose regimen would otherwise include lamivudine and the other components.
If using Combivir® or Trizivir®, consider that zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in those with advanced HIV infection; and that prolonged zidovudine use has been associated with symptomatic myopathy.
If using Trizivir®, consider that data are limited regarding use of the fixed combination in patients with higher viral loads (>100,000 copies/mL) at baseline.
Treatment of HIV infection in conjunction with other antiretrovirals.
A preferred or alternative NRTI for use in multiple-drug antiretroviral regimens for initial therapy in adults.
Fixed-combination preparation containing lamivudine and zidovudine (Combivir®) used in conjunction with other antiretrovirals.
Fixed-combination preparation containing lamivudine and abacavir (Epzicom®) used in conjunction with other antiretrovirals.
Fixed-combination preparation containing abacavir, lamivudine, and zidovudine (Trizivir®) used for triple NRTI treatment; can be used alone or in conjunction with other antiretrovirals. If using Trizivir®, consider that data are limited regarding use of the fixed combination in patients with higher viral loads (>100,000 copies/mL) at baseline.
Because of a high rate of virologic failure, a triple NRTI regimen of abacavir, lamivudine (or emtricitabine), and tenofovirnot recommended in treatment-naive or previously treated patients.
Because of inferior antiretroviral activity, a triple NRTI regimen of abacavir, lamivudine, and zidovudine is not recommended for initial therapy.
For patients coinfected with hepatitis B virus (HBV), some experts recommend an NRTI combination of tenofovir and (emtricitabine or lamivudine); avoid use of regimens containing only 1 of these antiretrovirals (may increase risk of HBV resistance).
Maternal-fetal Transmission of HIV
If a single-dose nevirapine regimen (alone or in conjunction with intrapartum/newborn zidovudine) is used for prevention of maternal-fetal transmission of HIV in women in labor who received no prior antiretroviral therapy, some clinicians suggest that consideration be given to adding zidovudine and lamivudine regimen in the mother and lamivudine in the neonate to reduce the development of nevirapine resistance.
Postexposure Prophylaxis of HIV
Postexposure prophylaxis of HIV infection† in health-care workers and others exposed occupationally via percutaneous injury or mucous membrane or nonintact skin contact with blood, tissues, or other body fluids associated with risk for transmission of the virus. Used in conjunction with other antiretrovirals.
Postexposure prophylaxis of HIV infection† in individuals who have had nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission. Used in conjunction with other antiretrovirals.
Chronic Hepatitis B Virus (HBV) Infection
Management of chronic HBV infection associated with evidence of HBV replication and active liver inflammation.
Safety and efficacy not established in patients with decompensated liver disease and there are no studies in pregnant women and no data regarding effect on vertical transmission of HBV.
Safety and efficacy for treatment of chronic HBV infection in patients coinfected with both HBV and HIV† have not been established.
Appears to reduce risk of HBV reinfection in orthotopic liver transplant recipients†.
Treatment of chronic HBV infection is complex and rapidly evolving and should be directed by clinicians familiar with the disease; consult a specialist to obtain the most up-to-date information.
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