Table 14. Antiretroviral Drug Use in Pregnancy: Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy

ABC (Ziagen)^c
Tablet:

• 300 mg

Oral Solution

• 20 mg/mL

ABC/3TC (Epzicom)^c

• ABC 600-mg/3TC 300-mg tablet

ABC/DTG/3TC (Triumeq)

• ABC 600-mg/DTG 50-mg/3TC 300-mg tablet

ABC/3TC/ZDV (Trizivir)^c

• ABC 300 mg/3TC 150-mg/ZDV 300-mg tablet

Pregnancy
PK in Pregnancy

• PK not significantly altered in pregnancy.

Dosing in Pregnancy

• No change in dose indicated.

For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., 3TC, ZDV, DTG).

Standard Adult Doses
ABC (Ziagen)

• ABC 300 mg twice daily or ABC 600 mg once daily, without regard to food

ABC/3TC (Epzicom)

• One tablet once daily without regard to food

ABC/DTG/3TC (Triumeq)

• One tablet daily without regard to food

ABC/3TC/ZDV (Trizivir)

• One tablet twice daily without regard to food

Emtricitabine

(FTC)
Emtriva

FTC/EFV/TDF)

(FTC/BIC/TAF)
Biktarvy

(FTC/RPV/TDF)
Complera

(FTC/TAF)
Descovy

(FTC/EVG/c/TAF)
Genvoya

(FTC/RPV/TAF)
Odefsey

(FTC/EVG/c/TDF)
Stribild

(FTC/DRV/c/TAF)
Symtuza

(FTC/TDF)
Truvada

Note: Generic products are available for some formulations.

FTC (Emtriva)
Capsule^c

• 200 mg

Oral Solution

• 10 mg/mL

FTC/EFV/TDF^c

• FTC 200-mg/EFV 60-mg/TDF 300-mg tablet

FTC/BIC/TAF (Biktarvy)

• FTC 200-mg/BIC 50-mg/TAF 25-mg tablet

FTC/RPV/TDF (Complera)

• FTC 200-mg/RPV 25-mg/TDF 300-mg tablet

FTC/TAF (Descovy)

• FTC 200-mg/TAF 25-mg tablet

FTC/EVG/c/TAF (Genvoya)

• FTC 200-mg/EVG 150-mg/COBI 150-mg/TAF 10-mg tablet

FTC/RPV/TAF (Odefsey)

• FTC 200-mg/RPV 25-mg/TAF 25-mg tablet

FTC/EVG/c/TDF (Stribild)

• FTC 200-mg/EVG 150-mg/COBI 150-mg/TDF 300-mg tablet

FTC/DRV/c/TAF (Symtuza)

• FTC 200-mg/DRV 800-mg/COBI 150-mg/TAF 10-mg tablet

FTC/TDF (Truvada)^c

• FTC 200-mg/TDF 300-mg tablet

Pregnancy 
PK in Pregnancy

• PK of FTC are not significantly altered in pregnancy.

Dosing in Pregnancy

• No change in dose indicated.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., TDF, TAF, EFV, RPV, DRV, EVG, BIC, COBI).

Standard Adult Doses
FTC (Emtriva)

• Capsule
  • FTC 200 mg once daily without regard to food
• Oral Solution
  • FTC 240 mg (24 mL) once daily without regard to food

FTC/EFV/TDF

• One tablet once daily at or before bedtime
• Take on an empty stomach to reduce or mitigate side effects.

FTC/BIC/TAF (Biktarvy)

• One tablet once daily with or without food

FTC/RPV/TDF (Complera)

• One tablet once daily with food

FTC/TAF (Descovy)

• One tablet once daily with or without food

FTC/EVG/c/TAF (Genvoya)

• One tablet once daily with food

FTC/RPV/TAF (Odefsey)

• One tablet once daily with food

FTC/EVG/c/TDF (Stribild)

• One tablet once daily with food

FTC/DRV/c/TAF (Symtuza)

• One tablet once daily with food

FTC/TDF (Truvada)

• One tablet once daily without regard to food

High placental transfer to fetus^b

No evidence of human teratogenicity (can rule out 1.5-fold increase in overall birth defects).

If patient has HBV/HIV coinfection, it is possible that an HBV flare may occur if the drug is stopped; see Hepatitis B Virus/HIV Coinfection.

3TC (Epivir)^c
Tablets

• 150 mg
• 300 mg

Oral Solution

• 10 mg/mL

3TC/TDF (Cimduo)

• 3TC 300-mg/TDF 300-mg tablet

3TC/ZDV^c

• 3TC 150-mg/ZDV 300-mg tablet

3TC/DOR/TDF (Delstrigo)

• 3TC 300-mg/DOR 100-mg/TDF 300-mg tablet

3TC/DTG (Dovato)

• 3TC 300-mg/DTG 50-mg tablet

3TC/ABC^c

• 3TC 300-mg/ABC 600-mg tablet

3TC/EFV/TDF (Symfi)^c

• 3TC 300-mg/EFV 600-mg/TDF 300-mg tablet

3TC/EFV/TDF (Symfi Lo)^c

• 3TC 300-mg/EFV 400-mg/TDF 300-mg tablet

3TC/ABC/DTG (Triumeq)

• 3TC 300-mg/ABC 600-mg/DTG 50-mg tablet

3TC/ABC/DTG (TriumeqPD)

• Pediatric dispersible tablet: 3TC 30-mg/ABC 60-mg/DTG 5-mg

3TC/ABC/ZDV^c

• 3TC 150-mg/ABC 300-mg /ZDV 300-mg tablet

Pregnancy
PK in Pregnancy

• PK not significantly altered in pregnancy.

Dosing in Pregnancy

• No change in dose indicated.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (ABC, DOR, DTG, EFV, TDF, ZDV).

Standard Adult Doses
3TC (Epivir)

• 3TC 150 mg twice daily or 300 mg once daily, without regard to food

3TC/TDF (Cimduo)

• One tablet once daily without regard to food

3TC/ZDV

• One tablet twice daily without regard to food

3TC/DOR/TDF (Delstrigo)

• One tablet once daily without regard to food

3TC/DTG (Dovato)

• One tablet once daily without regard to food

3TC/ABC

• One tablet once daily without regard to food

3TC/EFV/TDF (Symfi or Symfi Lo)

• One tablet once daily on an empty stomach and preferably at bedtime

3TC/ABC/DTG (Triumeq)

• One tablet once daily without regard to food

3TC/ABC/DTG (Triumeq PD)

• Triumeq PD is a pediatric dispersible tablet not intended for use in adults; it is not recommended for use in patients weighing 25 kg or more.

3TC/ABC/ZDV

• One tablet twice daily without regard to food

High placental transfer to fetus.^b

No evidence of human teratogenicity (can rule out 1.5-fold increase in overall birth defects).

If patient has HBV/HIV coinfection, it is possible that an HBV flare may occur if the drug is stopped; see Hepatitis B Virus/HIV Coinfection.

3TC products developed specifically for treatment of HBV (e.g., Epivir-HBV) contain a lower dose of 3TC that is not appropriate for treatment of HIV.

TAF (Vemlidy)
Tablet

• 25-mg

TAF/BIC/FTC (Biktarvy)

• TAF 25-mg/BIC 50-mg/FTC 200-mg tablet

TAF/FTC (Descovy)

• TAF 25- mg/FTC 200-mg tablet

TAF/EVG/c/FTC (Genvoya)

• TAF 10-mg/EVG 150-mg/COBI 150-mg /FTC 200-mg tablet

TAF/FTC/RPV (Odefsey)

• TAF 25- mg/FTC 200- mg/RPV 25-mg tablet

TAF/DRV/c/FTC (Symtuza)

• TAF 10-mg/DRV 800-mg/COBI 150-mg/FTC 200-mg tablet

Pregnancy
PK in Pregnancy

• AUC is lower in pregnancy, depending on the dose and concomitant ARV, but overall exposures are adequate.

Dosing in Pregnancy

• No change in dose indicated.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., BIC, COBI, DRV, EVG, FTC, RPV).

Standard Adult Doses
TAF (Vemlidy)

• One tablet once daily with food

TAF/BIC/FTC (Biktarvy)

• One tablet once daily with or without food

TAF/FTC (Descovy)

• One tablet once daily with or without food
• Same dose (TAF 25 mg) can be used with or without PK enhancers.

TAF/EVG/c/FTC (Genvoya)

• One tablet once daily with food

TAF/FTC/RPV (Odefsey)

• One tablet once daily with food

TAF/DRV/c/FTC (Symtuza)

• One tablet once daily with food

TAF

• Low placental transfer to fetus^b

TFV

• High placental transfer to fetus; plasma and cord blood concentrations lower than TDF^b

No evidence of human teratogenicity (can rule out twofold increase in overall birth defects)

Renal function should be monitored because of the potential for renal toxicity.

Tenofovir Disoproxil Fumarate
(TDF)
Viread

(TDF/EFV/FTC)
Atripla^d

(TDF/3TC)
Cimduo

(TDF/FTC/RPV)
Complera

(TDF/DOR/3TC)
Delstrigo

(TDF/EVG/c/FTC)
Stribild

(TDF/EFV/3TC)
Symfi

(TDF/EFV/3TC)
Symfi Lo

(TDF/FTC)
Truvada

Note: Generic products are available for some formulations.

TDF (Viread)

Tablet^c

• 300 mg

Powder

• 40 mg/1 g oral powder

TDF/EFV/FTC (Atripla)^c,d

• TDF 300 mg/‌EFV 600 mg/‌FTC 200 mg tablet

TDF/3TC (Cimduo)

• TDF 300 mg/‌3TC 300 mg tablet

TDF/FTC/RPV (Complera)

• TDF 300 mg/‌FTC 200 mg/‌RPV 25 ;mg tablet

TDF/DOR/3TC (Delstrigo)

• TDF 300 mg/‌DOR 100 mg/‌3TC 300 mg tablet

TDF/EVG/c/FTC (Stribild)

• TDF 300 mg/‌EVG 150 mg/‌COBI 150 mg/‌FTC 200 mg tablet

TDF/EFV/3TC (Symfi)

• TDF 300 mg/‌EF 600 mg/‌3TC 300 mg tablet

TDF/EFV/3TC (Symf Lo)

• TDF 300 mg/‌EFV 400 mg/‌3TC 300 mg tablet

TDF/3TC (Temixys)

• TDF 300 mg/‌3TC 300 mg tablet

TDF/FTC (Truvada)^c

• TDF 300 mg/‌FTC 200 mg tablet

Pregnancy

PK in Pregnancy

• AUC is lower in third trimester than postpartum, but trough levels are adequate.

Dosing in Pregnancy

• No change in dose is indicated.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., 3TC, COBI, DOR, EFV, EVG, FTC, RPV).

Standard Adult Doses
TDF (Viread)

• Tablet
  • TDF 300 mg once daily without regard to food
• Powder
  • TDF 8 mg/kg daily (up to a maximum of TDF 300 mg). Take with food.

TDF/EFV/FTC (Atripla)^d

• One tablet once daily at or before bedtime. Take on an empty stomach to reduce side effects.

TDF/3TC (Cimduo)

• One tablet once daily without regard to food

TDF/FTC/RPV (Complera)

• One tablet once daily with food

TDF/DOR/3TC (Delstrigo)

• One tablet once daily without regard to food

TDF/EVG/c/FTC (Stribild)

• One tablet once daily with food

TDF/EFV/3TC (Symfi or Symfi Lo)

• One tablet once daily on an empty stomach and preferably at bedtime

TDF/3TC (Temixys)

• One tablet once daily without regard to food

TDF/FTC (Truvada)

• One tablet once daily without regard to food

High placental transfer to fetus^b

No evidence of human teratogenicity (can rule out 1.5-fold increase in overall birth defects)

Human studies demonstrate no consistent link to LBW, but data are conflicting about potential effects on growth outcomes later in infancy.

If patient has HBV/HIV coinfection, an HBV flare may occur if TDF is stopped; see Hepatitis B Virus/HIV Coinfection.

Renal function should be monitored because of potential for renal toxicity.

ZDV (Retrovir) 
Capsule

• 100 mg

Tablet

• 300 mg

Oral Solution

• 10 mg/mL

IV Solution

• 10 mg/mL

ZDV/3TC

• ZDV 300-mg/3TC 150-mg tablet

ZDV/ABC/3TC

• ZDV 300-mg/ABC 300-mg/3TC 150-mg tablet

Pregnancy
PK in Pregnancy

• PK not significantly altered in pregnancy

Dosing in Pregnancy

• No change in dose indicated.
• Patients in active labor should receive ZDV 2 mg/kg IV as a loading dose, followed by ZDV 1 mg/kg/hour continuous infusion from beginning of active labor until birth.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., ABC, 3TC)

Standard Adult Doses
ZDV (Retrovir)

• ZDV 300 mg twice daily or ZDV 200 mg three times a day without regard to food

ZDV/3TC (Combivir)

• One tablet twice daily without regard to food

ZDV/ABC/3TC (Trizivir)

• One tablet twice daily without regard to food

Doravirine
(DOR)
Pifeltro

(DOR/3TC/TDF)
Delstrigo

DOR (Pifeltro)

• 100-mg tablet

DOR/3TC/TDF (Delstrigo)

• DOR 100-mg/3TC 300-mg/TDF 300-mg tablet

Pregnancy

PK in Pregnancy

• No PK studies in human pregnancy.

Dosing in Pregnancy

• Insufficient data to make dosing recommendations.

For guidance about the use of combination ARV drug products in pregnancy, please see the specific sections on other drug components (i.e., 3TC, TDF).

Standard Adult Doses

DOR (Pifeltro)

• DOR 100 mg once daily with or without food

DOR/3TC/TDF (Delstrigo)

• One tablet once daily with or without food

No human in vivo data are available on the placental transfer of DOR, but passage is noted in an ex vivo models.

Insufficient data are available to assess for teratogenicity in humans. No evidence exists of teratogenicity in rats or rabbits.

Efavirenz
(EFV)

(EFV/FTC/TDF)

(EFV/3TC/TDF)
Symfi

(EFV/3TC/TDF)
Symfi Lo

Note: Generic products are available for some formulations.

EFV

Capsules

• 50 mg
• 200 mg

Tablet

• 600 mg

EFV/FTC/TDF

• EFV 600-mg/FTC 200-mg/TDF 300­mg tablet

EFV/3TC/TDF (Symfi)

• EFV 600-mg/3TC 300-mg/TDF 300­mg tablet

EFV/3TC/TDF (Symfi Lo)

• EFV 400-mg/3TC 300-mg/TDF 300­mg tablet

Pregnancy

PK in Pregnancy

• AUC is decreased during the third trimester compared with postpartum, but nearly all third trimester participants exceeded target exposure.

Dosing in Pregnancy

• No change in dose is indicated.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., 3TC, FTC, TDF).

Standard Adult Doses

EFV (Sustiva)

• EFV 600-mg once daily at or before bedtime
• Take on an empty stomach to reduce side effects.

EFV/FTC/TDF

• One tablet once daily at or before bedtime
• Take on an empty stomach to reduce side effects.

EFV/3TC/TDF
(Symfi or Symfi Lo)

• One tablet once daily on an empty stomach and preferably at bedtime

Moderate placental transfer to fetus.^b

The FDA advises women to avoid becoming pregnant while taking EFV and advises health care providers to avoid administration during the first trimester of pregnancy because fetal harm may occur. However, the data on more than 7,900 periconception EFV exposures from Botswana rule out a threefold or greater increased risk of NTDs. As a result, the current Perinatal Guidelines do not restrict the use of EFV during pregnancy or when planning to become pregnant. This is consistent with both the British HIV Association and WHO guidelines for use of ARV drugs in pregnancy.

EFV should be continued in pregnancy when a virally suppressive, EFV-based regimen is being received, because ARV drug changes during pregnancy may be associated with loss of viral control and an increased risk of perinatal transmission (see  Antiretroviral Therapy Use During Prepregnancy and Early Pregnancy).

Tablet

• 25 mg
• 100 mg
• 200 mg

For patients who are unable to swallow tablets whole, the tablets may be dissolved in a glass of water.

Pregnancy
PK in Pregnancy

• PK data in pregnancy suggest 1.2-fold to 1.6-fold increases in ETR exposure during pregnancy.

Dosing in Pregnancy

• No change in dose indicated.

Standard Adult Doses

• 200 mg twice daily with food

NVP 
Tablet

• 200 mg^c

Oral Suspension:

• 50 mg/5 mL^c

Pregnancy

PK in Pregnancy

• PK of immediate-release tablets not significantly altered in pregnancy.
• No data available on extended-release formulations in pregnancy.

Dosing in Pregnancy

• No change in dose indicated.

Standard Adult Doses

• NVP 200 mg once daily (using immediate release tablet) for a 14-day lead-in period; thereafter, NVP 200 mg twice daily without regard to food.
• Repeat lead-in period if therapy is discontinued for >7 days.
• In patients who develop mild-to-moderate rash without constitutional symptoms during the lead-in period, continue lead-in dosing until rash resolves, but administer for ≤28 days total.

High placental transfer to fetus.^b

No evidence of human teratogenicity.

An increased risk of symptomatic liver toxicity exists when first initiating therapy in women with CD4 counts ≥250/mm³. Liver toxicity is often associated with a rash and can be fatal. Pregnancy does not appear to increase this risk.

NVP should be initiated in pregnant people with CD4 counts ≥250 cells/mm³ only if the benefit clearly outweighs the risk. A potential increased risk of life-threatening hepatotoxicity exists in pregnant people with high CD4 counts. Elevated transaminase levels at baseline may increase the risk of NVP toxicity.

Patients who become pregnant while taking NVP-containing regimens and who are tolerating their regimens well can continue taking those regimens, regardless of their CD4 counts.

Rilpivirine
(RPV)
Edurant

(RPV/FTC/TDF)
Complera

(RPV/DTG)
Juluca

(RPV/FTC/TAF)
Odefsey 

(CAB and RPV)
Cabenuva

CAB and RPV is a two-drug co-packaged product for IM injection.

RPV (Edurant)

Tablets

• 25 mg

RPV/FTC/TDF (Complera)

• RPV 25-mg/FTC 200-mg/TDF 300-mg tablet

RPV/DTG (Juluca)

• RPV 25-mg/DTG 50-mg tablet

RPV/FTC/TAF (Odefsey)

• RPV 25-mg/FTC 200-mg/ TAF 25-mg tablet

CAB and RPV (Cabenuva)

• CAB 200-mg/mL suspension for IM injection
• RPV 300-mg/mL suspension for IM injection

Pregnancy

PK in Pregnancy

• RPV PK are highly variable during pregnancy. RPV AUC and trough concentrations are 20% to 50% lower in pregnancy than postpartum. Although most pregnant women exceeded target exposure, those with detectable viral loads had lower RPV troughs.

Dosing in Pregnancy

• Although RPV plasma concentration is reduced during pregnancy, higher-than-standard doses have not been studied, and not enough data are available to recommend a dosing change during pregnancy. When standard dosing of RPV is received during pregnancy, viral loads should be monitored more frequently.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., CAB, DTG, FTC, TAF, TDF).

Standard Adult Doses

RPV (Edurant)

• RPV 25 mg once daily with food

RPV/FTC/TDF (Complera)

• One tablet once daily with food

RPV/DTG (Juluca)

• One tablet once daily with food

RPV/FTC/TAF (Odefsey)

• One tablet once daily with food

CAB and RPV (Cabenuva)

• Refer to Cabotegravir for dosing and instructions.

Atazanavir
(ATV)
Reyataz

Note: Generic products are available for some formulations.

Note: ATV must be combined with low-dose RTV boosting in pregnancy.

(ATV/c)
Evotaz

ATV (Reyataz)

Capsules

• 100 mg^c (generic product only)
• 150 mg^c(generic product only)
• 200 mg^c
• 300 mg^c

Oral Powder

• 50-mg packet

ATV/c (Evotaz)

• ATV 300-mg/COBI 150-mg tablet

Pregnancy

PK in Pregnancy

• ATV (Reyataz)
  • ATV concentrations are reduced during pregnancy, and they are further reduced when ATV is given concomitantly with TDF or an H2-receptor antagonist.
  • Intracellular ATV levels in women taking the standard dose (ATV/r 300 mg/100 mg) without concomitant TDF appear reassuringly stable throughout pregnancy.
• ATV/c (Evotaz)
  • Use of ATV/c is not recommended during pregnancy because ATV C_trough are 80% to 85% lower than the ATV concentrations seen in nonpregnant adults.

Dosing in Pregnancy

• ATV (Reyataz)
  • Use of unboosted ATV is not recommended during pregnancy.
  • Use of unboosted ATV is not recommended for ARV-experienced patients who are taking TDF and an H2-receptor antagonist.
  • Use of an increased dose (ATV/r 400 mg/100 mg once daily with food) during the second and third trimesters results in plasma ATV concentrations equivalent to those seen in nonpregnant adults receiving standard dosing. Increased ATV dosing is recommended during the second and third trimesters when either TDF or an H2-receptor antagonist is also being received.
• ATV/c (Evotaz)
  • ATV/c should not be used in pregnancy because atazanavir C_min is substantially reduced (see COBI).

For guidance about the use of combination products in pregnancy, see the specific sections on other components (i.e., COBI).

Standard Adult Doses

In ARV-Naive Patients Without RTV Boosting

• ATV 400 mg once daily with food; ATV without RTV boosting is not recommended when used with TDF, H2-receptor antagonists, PPIs, or during pregnancy.

In ARV-Naive Patients With RTV Boosting

• ATV/r 300 mg/100 mg once daily with food
• When combined with EFV in ARV-naive patients: ATV/r 400 mg/100 mg once daily with food

In ARV-Experienced Patients

• ATV 300 mg plus RTV 100 mg once daily with food
• Do not use with PPIs or EFV.

In ARV-Experienced Patients Who Are Receiving an H2-Receptor Antagonist

• ATV/r 300/100 mg once daily with food

In ARV-Experienced Patients Who Are Receiving an H2-Receptor Antagonist and TDF

• ATV/r 400 mg/100 mg once daily with food

Powder Formulation

• Oral powder is taken with RTV once daily with food at the same recommended adult dose as the capsules.

ATV/c (Evotaz)

• One tablet once daily with food

Low placental transfer to fetus^b

No evidence of human teratogenicity (can rule out 1.5-fold increase in overall birth defects)

Must be given with RTV boosting in pregnancy.

Effect of in utero ATV exposure on infant indirect bilirubin levels is unclear. Nonpathologic elevations of neonatal bilirubin have been observed in some, but not all, clinical trials to date.

Oral powder (but not capsules) contains phenylalanine, which can be harmful to patients with phenylketonuria.

Use of ATV/c is not recommended during pregnancy. See Recommendations for Use of Antiretroviral Drugs During Pregnancy, Table 6 and Table 7 for discussions about avoiding the use of ATV/c during pregnancy.

Note: Please see FDA label for full list of drugs with potential interactions, including several anticonvulsants and other drugs for which administration with ATV/r is contraindicated.

Darunavir
(DRV)
Prezista

Note: Must be combined with low-dose RTV or COBI boosting.

(DRV/c)
Prezcobix

(DRV/c/FTC/TAF)
Symtuza

DRV (Prezista)

Tablets

• 75 mg
• 150 mg
• 600 mg
• 800 mg

Oral Suspension

• 100 mg/mL

DRV/c (Prezcobix)

• DRV/c 800-mg/150-mg tablet

DRV/c/FTC/TAF (Symtuza)

• DRV 800-mg/
  COBI 150-mg/
  FTC 200-mg/
  TAF 10-mg tablet

Pregnancy

PK in Pregnancy

• Decreased exposure in pregnancy with use of DRV/r

Dosing in Pregnancy

• The Panel does not recommend once-daily dosing with DRV/r during pregnancy or the use of DRV/c during pregnancy.
• Twice-daily DRV/r dosing (DRV/r 600 mg/100 mg with food) is recommended during all pregnancies.
• Increased twice-daily DRV dose (DRV/r 800 mg/‌100 mg with food) during pregnancy does not result in an increase in DRV exposure and is not recommended.

For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., COBI, FTC, TAF).

Standard Adult Doses

Patients Who Are ARV-Naive

• DRV/r 800 mg/100 mg once daily with food
• DRV/c 800 mg/150 mg once daily with food

ARV-Experienced Patients If Patient Has No DRV Resistance Mutations

• DRV/r 800 mg/100 mg once daily with food
• DRV/c 800 mg/150 mg once daily with food

ARV-Experienced Patients If Any DRV Resistance Mutations Are Present

• DRV/r 600 mg/100 mg twice daily with food

DRV/c (Prezcobix)

• One tablet once daily with food

DRV/c/FTC/TAF (Symtuza)

• One tablet once daily with food

Low placental transfer to fetus^b

No evidence of teratogenicity in mice, rats, or rabbits. No evidence of human teratogenicity.

Must be boosted with low-dose RTV

The Panel does not recommend once-daily dosing with DRV/r during pregnancy or the use of DRV/c during pregnancy. If a DRV/c regimen is continued during pregnancy, viral load should be monitored frequently.

Lopinavir/Ritonavir
(LPV/r)
Kaletra

Note:  Generic products are available for all formulations.

LPV/r (Kaletra)^c
Tablets

• LPV/r 200 mg/50 mg
• LPV/r 100 mg/25 mg

Oral Solution

• Each 5 mL contains LPV/r 400 mg/100 mg

Pregnancy
PK in Pregnancy

• With twice-daily dosing, LPV exposure is reduced in pregnant women who receive standard adult doses; increasing the dose by 50% results in exposure equivalent to that seen in nonpregnant adults receiving standard doses.
• No PK data are available for once-daily dosing in pregnancy.

Dosing in Pregnancy

• Once-daily dosing is not recommended during pregnancy.
• Some experts recommend that an increased dose (i.e., LPV/r 600 mg/150 mg twice daily without regard to meals or LPV/r 500 mg/125 mg twice daily without regard to meals) should be used in the second and third trimesters, especially in PI-experienced pregnant women and women who start treatment during pregnancy with a baseline viral load >50 copies/mL.
• When standard dosing is used, monitor virologic response and, if possible, LPV drug levels.

Standard Adult Doses

• LPV/r 400 mg/100 mg twice daily, or
• LPV/r 800 mg/200 mg once daily

Tablet

• Take without regard to food.

Oral Solution

• Take with a meal.

With EFV or NVP in PI-Naive or PI-Experienced Patients:

• LPV/r 500-mg/125-mg tablets twice daily without regard to meals (use a combination of two LPV/r 200-mg/50-mg tablets and one LPV/r 100 mg/25 mg tablet), or
• LPV/r 520-mg/130-mg oral solution (6.5 mL) twice daily with food

• Extended-Release Tablet: 600 mg

Pregnancy
PK in Pregnancy

• No PK studies in human pregnancy

Dosing in Pregnancy

• Insufficient data to make dosing recommendation

Standard Adult Doses

(FTR) Rukobia

• FTR 600 mg twice daily with or without food

No human data are available regarding placental passage. A study in rats demonstrates placental passage of temsavir or other metabolites.

Insufficient data to assess for teratogenicity in humans. No evidence of teratogenicity in rats or rabbits.

IV Solution

• 150 mg/mL

Pregnancy
PK in Pregnancy

• No PK studies in human pregnancy.

Dosing in Pregnancy

• Insufficient data to make dosing recommendations.

Standard Adult Doses

IV infusion (diluted infusion with 250 mL 0.9% sodium chloride)

• IBA 2,000-mg loading dose over 30 minutes, followed by IBA 800-mg maintenance doses over 15 minutes administered every 2 weeks

IV push (undiluted)

• IBA 2,000-mg loading dose over 90 seconds, followed by IBA 800-mg maintenance doses over 30 seconds administered every 2 weeks

No human data are available, but placental transfer of IBA, a monoclonal antibody, is possible and documented in monkeys.

Based on data in cynomologus monkeys with in utero exposure, potential exists for reversible immunosuppression (CD4 T-cell and B-cell lymphocytopenia) in infants born to individuals exposed to IBA during pregnancy.

The FDA requires collection of prospective data on IBA exposure during pregnancy to monitor maternal and pregnancy outcomes, including adverse effects on the developing fetus, neonate, and infant.

Insufficient data to assess for teratogenicity in humans.

Tablets

• 150 mg
• 300 mg

Pregnancy

PK in Pregnancy

• A PK study in human pregnancy demonstrated a 20% to 30% overall decrease in MVC AUC, but C_trough exceeded the recommended minimum concentration of 50 ng/mL.

Dosing in Pregnancy

• Adjusting the standard adult MVC dose for concomitant use with ARV drugs seems appropriate.

Standard Adult Doses

• MVC 300 mg twice daily with or without food
• MVC should be used only for patients with CCR5-tropic virus (and no X4-tropic virus).

Dose Adjustments

• Increase to MVC 600 mg twice daily when used with the potent CYP3A inducers EFV, ETR, and rifampin.
• Decrease to MVC 150 mg twice daily when used with CYP3A inhibitors, which include all PIs except TPV/r and itraconazole.

LEN (Sunlenca)

• LEN 300-mg tablets for oral administration
• LEN 463.5 mg/1.5 mL for SQ injection

Pregnancy
PK in Pregnancy

• No PK studies in human pregnancy

Dosing in Pregnancy

• Insufficient data to make dosing recommendations

Standard Adult Doses
Initiation Option 1

• Day 1: 927 mg by SQ injection (2 x 1.5 mL injections) and 600‍mg orally (2 x 300-mg tablets)
• Day 2: 600 mg orally (2 x 300-‍mg tablets).

Initiation Option 2

• Day 1: 600 mg orally (2 x 300-‍mg tablets)
• Day 2: 600 mg orally (2 x 300-‍mg tablets)
• Day 8: 300 mg orally (1 x 300-‍mg tablet)
• Day 15: 927 mg by SQ injection (2 x 1.5 mL injections)

Maintenance Dosing

• 927 mg by SQ injection (2 x 1.5 mL injections) every 26 weeks +/- 2 weeks from date of last injection

No human data are available regarding placental or breast milk.

Data are insufficient to assess for teratogenicity in humans. No evidence of teratogenicity in rats or rabbits.

Bictegravir/Emtricitabine/ Tenofovir Alafenamide
(BIC/FTC/TAF)
Biktarvy

Note: BIC is available only as part of an FDC tablet.

BIC/FTC/TAF (Biktarvy)

• BIC 50-mg/FTC 200-mg/TAF 25-mg tablet
• BIC 30-mg/FTC 120-mg/TAF 15-mg tablet

Pregnancy
PK in Pregnancy

• AUC and C_24h/C_trough are decreased during the third trimester compared with postpartum, but exposures during pregnancy are well above those needed to inhibit viral replication.

Dosing in Pregnancy

• No change in dose indicated

For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., FTC, TAF).

Standard Adult Doses

• One tablet of BIC 50 mg/FTC 200 mg/TAF 25 mg once daily with or without food

High placental transfer to fetus^b

No evidence of human teratogenicity (can rule out twofold increase in overall birth defects)

BIC can be taken with food at the same time as any preparation containing iron or calcium—including prenatal vitamins—but should not be administered within 2 hours of these preparations when taken on an empty stomach. BIC can be taken at least 2 hours before or 6 hours after antacids containing aluminum or magnesium.

Cabotegravir
(CAB)
Vocabria (oral)
Apretude (injection for HIV pre-exposure prophylaxis)

(CAB)
Cabenuva

Note: CAB and RPV is a two-drug co-packaged product for IM injection.

CAB

• CAB 30-mg tablets for oral administration
• CAB 200-mg/mL suspension for IM injection

CAB and RPV

• CAB 200-mg/mL suspension for IM injection
• RPV 300-mg/mL suspension for IM injection

Pregnancy

PK in Pregnancy

• No published PK studies in human pregnancy

Dosing in Pregnancy

• Insufficient data to make dosing recommendations

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., RPV).

Standard Adult Doses

Oral Lead-in Therapy (Optional)

• CAB (Vocabria)
  • One 30-mg tablet once daily in combination with RPV (Edurant) 25-mg once daily taken with a meal for 4 weeks
• CAB (Apretude)
  • Initiation
    • CAB 600-mg (3 mL) injection given 1 month apart for 2 consecutive months (on the last day of an oral lead-in if used or within 3 days)
  • Continuation Therapy
    • CAB 600-mg (3 mL) injections every 2 months thereafter
• CAB and RPV (Cabenuva)
  • Initiation
    • CAB 600-mg (3 mL) and RPV 900-mg (3 mL), given as two separate injections in separate ventrogluteal sites for 2 consecutive months (on the last day of an oral lead-in, if used)
  • Continuation Therapy
    • Monthly: CAB 400-mg (2 mL) and RPV 600-mg (2 mL), given as two separate injections in separate ventrogluteal sites once a month with allowance for a +/- 7‑day administration window
    • Every 2 months: Starting in month 4, CAB 600-mg (2 mL) and RPV 900-mg (2 mL), given as two separate injections in separate ventrogluteal sites once a month with allowance for a +/- 7‑day administration window
    • Patients should be monitored for approximately 10 minutes for postinjection reactions. A 23‑gauge, 1.5‑inch IM needle is recommended for the injection and is provided in the packaging. Longer, 2‑inch needles should be used in patients with BMIs >30 kg/m².

Changing Dosing Frequency and Managing Missed Doses

• Refer to the package insert for instructions about changing the frequency of continuation doses and managing missed doses (see Apretude and Cabenuva)

No human data are available regarding placental passage.

Insufficient data to assess for teratogenicity in humans. No evidence of teratogenicity in rats or rabbits.

Dolutegravir

(DTG)
Tivicay
Tivicay PD

(DTG/3TC)
Dovato

(DTG/RPV)
Juluca

(DTG/ABC/3TC)
Triumeq

DTG (Tivicay)

• DTG 10-mg, 25-mg, and 50-mg film-coated tablets

DTG (Tivicay PD)

• DTG 5-mg dispersible tablet for oral suspension

DTG film-coated tablets and DTG dispersible tablets are not bioequivalent and are not interchangeable.

DTG/3TC (Dovato)

• DTG 50-mg/ 3TC 300-mg tablet

DTG/RPV (Juluca)

• DTG 50-mg/‌RPV 25-mg tablet

DTG/ABC/3TC (Triumeq)

• DTG 50-mg/‌ABC 600-mg/‌3TC 300-mg tablet

Pregnancy

PK in Pregnancy

• AUC may be decreased during the third trimester compared with postpartum, but exposures during pregnancy are well above those needed to inhibit viral replication.

Dosing in Pregnancy

• No change in dose indicated.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., ABC, 3TC, RPV).

Standard Adult Doses

In ARV-Naive or ARV‑Experienced (but INSTI-Naive) Patients

• DTG (Tivicay)
  • One 50-mg tablet once daily, without regard to food
• DTG (Tivicay PD)
  • Six 5-mg tablets (30 mg) dissolved in water once daily, without regard to food
• DTG/3TC (Dovato)
  • One tablet once daily, without regard to food
• DTG/RPV (Juluca)
  • One tablet once daily, with food
• DTG/ABC/3TC (Triumeq)
  • One tablet once daily, without regard to food

In ARV-Naive or ARV‑Experienced (but INSTI-Naive) Patients Who Are Also Receiving EFV, FPV/r, TPV/r, or Rifampin

• DTG (Tivicay)
  • One 50-mg tablet twice daily, without regard to food
• DTG (Tivicay PD)
  • Six 5-mg tablets (30 mg) dissolved in water twice daily, without regard to food

In INSTI-Experienced Patients

• DTG (Tivicay)
  • One tablet twice daily, without regard to food

High placental transfer to fetus^b

No evidence of teratogenicity in rats or rabbits. The most recent data from Botswana indicate the prevalence of NTDs in infants born to pregnant women with HIV receiving DTG at conception is no longer statistically different than in those receiving other ARVs.

DTG is a Preferred ARV drug for use during pregnancy, irrespective of trimester, and when trying to conceive (see Recommendations for Use of Antiretroviral Drugs During Pregnancy and Table 7).

To maximize DTG absorption, doses should not be administered within 2 hours of ingesting any preparation that contains such minerals as iron or calcium, including prenatal vitamins.

EVG/c/FTC/TAF (Genvoya)

• EVG 150-mg/COBI 150-mg/FTC 200-mg/TAF 10-mg tablet

EVG/c/FTC/TDF (Stribild)

• EVG 150-mg/COBI 150-mg/FTC 200-mg/TDF 300-mg tablet

Pregnancy
PK in Pregnancy

• PK studies in women who received EVG/c demonstrated significant reduction in EVG plasma exposure during pregnancy.

Dosing in Pregnancy

• EVG plasma concentrations are reduced with use of standard adult doses during pregnancy; however, higher-than-standard doses of EVG have not been studied. Insufficient data are available to recommend a dose for use in pregnancy.

For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., COBI, FTC, TAF).

Standard Adult Doses
Genvoya and Stribild

• One tablet once daily with food

Evidence of high placental transfer of EVG and low transfer of COBI^b

Insufficient data to assess for teratogenicity in humans. No evidence of teratogenicity in rats or rabbits.

EVG/c is not recommended for use in pregnancy. If EVG/c is being taken when pregnancy occurs, consider frequent viral load monitoring or switching to a more effective recommended regimen. If a regimen that contains EVG/c is continued during pregnancy, doses should be administered with a meal and should not be administered within 2 hours of ingesting any preparation that contains minerals, such as iron or calcium, including prenatal vitamins.

RAL (Isentress)

Film-Coated Tablets

• 400 mg

Chewable Tablets

• 25 mg
• 100 mg

RAL (Isentress HD)

Film-Coated Tablets

• 600 mg

Pregnancy

PK in Pregnancy

• Decreased drug concentrations in the third trimester are not of sufficient magnitude to warrant a change in dosing.

Dosing in Pregnancy

• No change in dose is indicated.
• Once-daily dosing (i.e., two RAL 600-mg, film-coated tablets) should not be used during pregnancy until more information is available.

Standard Adult Doses

In Patients Who Are Not Receiving Rifampin

• RAL 400-mg film-coated tablets twice daily without regard to food
• Two RAL 600-mg film-coated tablets (1,200 mg) once daily without regard to food for patients who are ARV-naive or patients who are already virologically suppressed on an initial regimen of RAL 400 mg twice daily
• Chewable tablets and oral suspension doses are not interchangeable with either film-coated tablets or each other.

In Patients Who Are Receiving Rifampin

• Two RAL 400-mg film-coated tablets (800 mg) twice daily without regard to food.

High placental transfer to fetus^b

No evidence of human teratogenicity (can rule out a 1.5-fold increase in overall birth defects).

There is a case report of markedly elevated liver transaminases with RAL use in late pregnancy. Severe, potentially life-threatening, and fatal skin reactions and HSRs have been reported in nonpregnant adults.

RAL chewable tablets contain phenylalanine.

To maximize RAL absorption, doses should not be administered within 2 hours of ingestion of any preparation containing minerals—such as iron or calcium—including prenatal vitamins.

COBI (Tybost)

Tablet

• COBI 150 mg

ATV/c (Evotaz)

• ATV 300-mg/COBI 50-mg tablet

EVG/c/FTC/TAF (Genvoya)

• EVG 150-mg/COBI 150-mg/FTC 200-mg/TAF 10-mg tablet

DRV/c (Prezcobix)

• DRV 800-mg/COBI 150-mg tablet

EVG/c/FTC/TDF (Stribild)

• EVG 150-mg/COBI 150-mg/FTC 200-mg/TDF 300-mg tablet

DRV/c/FTC/TAF (Symtuza)

• DRV 800-mg/COBI 150-mg/FTC 200-mg/TAF 10-mg tablet

Pregnancy
PK in Pregnancy:

• Based on limited data, COBI exposure and its pharmacoenancing effect on ATV, DRV, and EVG are reduced markedly in pregnancy.
• When coadministered with COBI, TAF exposure is not significantly different between pregnancy and the postpartum period.

Dosing in Pregnancy:

• Although COBI exposure is markedly reduced during pregnancy, higher-than-standard doses have not been studied. The Panel recommends RTV as the preferred pharmacoenhancer for PIs and INSTIs during pregnancy until more data are available on COBI activity during pregnancy.

For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., FTC, TAF, TDF, ATV, DRV, EVG).

Standard Adult Doses

COBI (Tybost)

• When used as an alternative PK booster with ATV or DRV, the dose is one tablet once daily with food.

ATV/c (Evotaz)

• One tablet once daily with food

EVG/c/FTC/TAF (Genvoya)

• One tablet once daily with food

DRV/c (Prezcobix)

• One tablet once daily with food

EVG/c/FTC/TDF (Stribild)

• One tablet once daily with food

DRV/c/FTC/TAF (Symtuza)

• One tablet once daily with food

RTV (Norvir)
Capsule

• RTV 100 mg

Tablet

• RTV 100 mg

Powder

• RTV 100 mg/sachet

LPV/r (Kaletra)
Tablets

• LPV/r 200 mg/50 mg
• LPV/r 100 mg/25 mg

Oral Solution

• Each 5 mL contains LPV/r 400 mg/100 mg

Pregnancy
PK in Pregnancy

• Lower RTV levels are seen during pregnancy than during postpartum, which may reduce the pharmacoenhancing effect of RTV in pregnancy.

RTV Dosing in Pregnancy

• No dose adjustment necessary when RTV is used as booster.

LPV/r Dosing in Pregnancy

• Once-daily dosing is not recommended during pregnancy.
• Some experts recommend that an increased dose (i.e., LPV/r 600 mg/150 mg twice daily without regard to meals or LPV/r 500 mg/125 mg twice daily without regard to meals) should be used in the second and third trimesters of pregnancy, especially in patients who are PI-experienced and in those who start treatment during pregnancy with a baseline viral load >50 copies/mL.
• When standard dosing is used, monitor virologic response and, if possible, LPV drug levels.

For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., LPV/r).

Standard Adult Dose of RTV (Norvir) When Used as a PK Booster for Other PIs

• RTV 100–400 mg per day in one or two divided doses (refer to other PI sections for specific dosing recommendations)

Tablet

• Take with food

Capsule or Powder

• To improve tolerability, take with food, if possible.

Standard Adult Doses of LPV/r (Kaletra)

• LPV/r 400 mg/100 mg twice daily, or
• LPV/r 800 mg/200 mg once daily

Tablet

• Take without regard to food.

Oral Solution

• Take with food.

With EFV or NVP in PI-Naive or PI-Experienced Patients

• LPV/r 500-mg/125-mg tablets twice daily without regard to meals (use a combination of two LPV/r 200-mg/50-mg tablets and one LPV/r 100-mg/25-mg tablet), or
• LPV/r 520-mg/130-mg oral solution (6.5 mL) twice daily with food

^a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Antiretroviral Guidelines, Appendix B).

^b Placental transfer categories are determined by mean or median cord blood–to–maternal delivery plasma drug ratio:

High: >0.6
Moderate: 0.3–0.6
Low: <0.3

^c Generic product is available.

^d As of June 2023, Atripla brand products are no longer available.

Key: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; AUC = area under the curve; BIC = bictegravir; BMI = body mass index; C_24h = concentrations at 24 hours postdose; CAB = cabotegravir; CD4 = CD4 T lymphocyte; COBI = cobicistat; CYP = cytochrome P; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DRV/r = darunavir/ritonavir; DTG = dolutegravir; EFV = efavirenz; ETR = etravirine; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDA = U.S. Food and Drug Administration; FDC = fixed-dose combination; FPV/r = fosamprenavir/ritonavir; FTC = emtricitabine; FTR = fostemsavir; HBV = hepatitis b virus; HSR = hypersensitivity reaction; IBA = ibalizumab; IM = intramuscular; INSTI = integrase strand transfer inhibitor; IV = intravenous; LEN = lenacapavir; LPV = lopinavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NTD = neural tube defect; NVP = nevirapine; PI = protease inhibitor; PK = pharmacokinetic; PPI = proton pump inhibitor; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SQ = subcutaneous; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV = tipranavir; TPV/r = tipranavir/ritonavir; WHO = World Health Organization; ZDV = zidovudine