Dolutegravir Sodium and SPB11

• Generic Name: dolutegravir
• Dosage Forms: n.a.
• Other Brand Names: Tivicay

Treatment of HIV-1 infection in adults, adolescents, and pediatric patients weighing ≥30 kg; usually used in conjunction with 2 HIV NRTIs (dual NRTIs).

For initial treatment in antiretroviral-naive adults and adolescents, experts state that dolutegravir in conjunction with tenofovir alafenamide and emtricitabine or dolutegravir in conjunction with tenofovir disoproxil fumarate (tenofovir DF) and emtricitabine (or lamivudine) are recommended INSTI-based regimens. Dolutegravir in conjunction with abacavir and lamivudine (or emtricitabine) also is a recommended INSTI-based regimen for initial treatment, but use only in those who are HLA-B*5701 negative.

For initial treatment in antiretroviral-naive pediatric patients, experts state that an INSTI-based regimen of dolutegravir in conjunction with 2 NRTIs is a preferred regimen in those ≥6 years of age weighing ≥30 kg.

In antiretroviral-experienced adults and adolescents, dolutegravir usually used in INSTI-based regimens that include dolutegravir and an optimized background antiretroviral regimen (OBR).

In certain virologically suppressed antiretroviral-experienced adults (i.e., those with plasma HIV-1 RNA levels <50 copies/mL on a stable antiretroviral regimen for ≥6 months who have no known history of treatment failure and are infected with HIV-1 with no known substitutions associated with resistance to dolutegravir or rilpivirine), a 2-drug regimen of dolutegravir and rilpivirine can be used to replace the current regimen. If the 2-drug regimen is used in such adults, single-entity dolutegravir and single-entity rilpivirine can be used concomitantly or the commercially available fixed combination of dolutegravir and rilpivirine (dolutegravir/rilpivirine; Juluca) can be used.

Fixed combination containing abacavir, dolutegravir, and lamivudine (abacavir/dolutegravir/lamivudine; Triumeq) is used alone or in conjunction with other antiretrovirals in adults, adolescents, and pediatric patients weighing ≥40 kg. Do not use abacavir/dolutegravir/lamivudine alone in patients with suspected or confirmed INSTI-resistance substitutions; dosage of dolutegravir in the fixed combination insufficient in such patients.

Postexposure prophylaxis of HIV infection following nonoccupational exposure (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that might contain HIV when the exposure represents a substantial risk for HIV transmission. Used in conjunction with other antiretrovirals.

When nPEP indicated in adults and adolescents ≥13 years of age with normal renal function, CDC states preferred regimen is either raltegravir or dolutegravir used in conjunction with emtricitabine and tenofovir DF (given as emtricitabine/tenofovir DF; Truvada); recommended alternative in these patients is ritonavir-boosted darunavir used in conjunction with emtricitabine/tenofovir DF.

Consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or the National Clinicians’ Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) if nPEP indicated in certain exposed individuals (e.g., pregnant women, children, those with medical conditions such as renal impairment) or if considering a regimen not included in CDC guidelines, source virus is known or likely to be resistant to antiretrovirals, or healthcare provider is inexperienced in prescribing antiretrovirals. Do not delay initiation of nPEP while waiting for expert consultation.

• Generic Name: sodium phenylbutyrate
• Dosage Forms: oral powder
• Other Brand Names: Buphenyl

Sodium phenylbutyrate is used together with a proper diet to help treat urea cycle disorders (including a specific liver enzyme deficiency) that help remove ammonia (nitrogen) from the body.

Ammonia is formed from the breakdown of protein in the body. If the ammonia cannot be removed by the body, then a buildup may cause serious unwanted effects. This medicine works by helping to reduce high levels of ammonia in the blood.

This medicine is available only with your doctor's prescription.