Tenofovir use while Breastfeeding
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Tenofovir Levels and Effects while Breastfeeding
Summary of Use during Lactation
Tenofovir is available in the U.S. in two forms, tenofovir disoproxil fumarate and tenofovir alafenamide. Both release tenofovir, but tenofovir disoproxil fumarate releases tenofovir in the bloodstream whereas tenofovir alafenamide enters cells before releasing tenofovir. Most published experience is with tenofovir disoproxil fumarate in HIV therapy and prophylaxis. Exposure of the breastfed infant to tenofovir is trivial in HIV-positive mothers and HIV-negative mothers treated for HIV prophylaxis or hepatitis B infection. Some data indicate that tenofovir milk levels decrease with time after delivery. Among HIV-positive mothers who have breastfed during tenofovir disoproxil fumarate therapy no infant adverse effects have occurred up to 2 years of age. Pre-exposure prophylaxis (PrEP) regimens containing tenofovir are acceptable for use in HIV-negative nursing mothers. Maternal use of prophylactic vaginal tenofovir (investigational in the U.S.) also does not appear to present a risk to the breastfed infant.
In hepatitis B, expert reviews of available data and most professional guidelines state that there is no justification for contraindicating the use of tenofovir during breastfeeding.[4-8] One guideline suggests discussing the lack of long-term safety data with the mother. No differences exist in infection rates between breastfed and formula-fed infants born to hepatitis B-infected women, as long as the infant receives hepatitis B immune globulin and hepatitis B vaccine at birth.
Tenofovir has very poor bioavailability and is available commercially as the more bioavailable tenofovir disoproxil fumarate and tenofovir alfenamide. Tenofovir disoproxil fumarate releases tenofovir in the bloodstream whereas tenofovir alafenamide enters cells before releasing tenofovir. Both are metabolized intracellularly to the active metabolite tenofovir diphosphate. The bioavailabilities of tenofovir and tenofovir diphosphate from breastmilk are not known, but presumed to be very low. Tenofovir (not in a salt form) is also being investigated as a gel for vaginal use in prophylaxis.
Maternal Levels. Tenofovir disoproxil fumarate. Five exclusively breastfeeding mothers received oral tenofovir disoproxil fumarate 300 mg plus emtricitabine 200 mg and nevirapine 200 mg at the start of labor, then oral tenofovir disoproxil fumarate 300 mg daily and emtricitabine 200 mg for 7 days postpartum. A total of 16 concurrent maternal blood and milk samples were collected on days 1, 2, 3, and 7 postpartum between 10 minutes and 21 hours after the mothers’ doses. Median peak and trough tenofovir concentrations in breastmilk were 14.1 mcg/L and 6.8 mcg/L, respectively. The authors estimated that an exclusively breastfed infant would receive about 0.03% of the proposed infant dose for tenofovir and achieve trivial infant serum concentrations that would likely have no adverse consequences.
In a multicenter study in Malawi and Brazil, mothers were given a single dose of either 600 mg or 900 mg of tenofovir disoproxil fumarate during labor. Breastmilk samples were collected from mothers at various times postpartum. Tenofovir was detected (>2.5 mcg/L) in three-fourths of samples collected from 25 mothers during the first 2 days postpartum. Levels ranged from 6.3 to 17.8 mcg/L. At 4 to 6 days postpartum, only one milk sample of 21 had a detectable tenofovir level of 15.7 mcg/L.
Women in Malawi received the option B+ regimen for prevention of mother-to-child transmission of HIV consisting of tenofovir disoproxil fumarate, lamivudine and efavirenz between 6 and 8 pm daily. The tenofovir disoproxil fumarate dose was not stated, but was presumably 300 mg daily. Milk samples collected in the morning from 33 women at month 1 postpartum had a median tenofovir concentration of 5 mcg/L (IQR 0 to 6.1 mcg/L). Milk samples collected in the morning from 47 women at month 12 postpartum had a median tenofovir concentration of 2.5 mcg/L (IQR 0 to 5.5 mcg/L).
Fifty HIV-negative women who were nursing their infants were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days. On days 7 and 10 of therapy, peak milk samples were obtained 1 to 2 hours after a dose and trough samples were obtained 23 to 24 hours after the previous dose. The median peak milk tenofovir concentration was 3.2 mcg/L and the trough concentration was 3.3 mcg/L. These values represent an estimated daily dosage of 0.47 to 0.49 mcg/kg, which is less than 0.01% of the proposed infant therapeutic dosage.
Tenofovir was measured in 6 HIV-positive nursing mothers after a 300 mg dose of tenofovir disoproxil fumarate during ongoing therapy. Tenofovir reached a peak breastmilk concentration of 5.9 mcg/L (range 5.5 to 8.0 mcg/L) at an average of 3 hours (range 1 to 7) hours after the dose.
Forty-eight Nigerian and Ugandan women took 300 mg of tenofovir disoproxil fumarate once daily as part of a combination therapy for HIV. Expressed milk samples were taken before the dose and at several times in the 12 hours after the morning dose (n = 30) or at 12, 16 and 20 hours after a dose given the previous evening (n = 18). The median peak breastmilk concentration from dried breastmilk spots was 5.98 mcg/L (IQR 0 to 8.05 mcg/L) at a median of 4 hours after the dose (IQR 1 to 6 hours).
A meta-analysis of 4 previous studies[9,11,12,14] calculated that breastfed infants would receive only 0.03% of the recommend dose of tenofovir.
Eleven mothers with chronic hepatitis B who had been taking tenofovir disoproxil fumarate 245 mg daily for at least one month donated breastmilk samples at a median of 12 hours (IQR 10 to 17 hours) after a dose. The median concentration in breastmilk was 6.69 mcg/L (IQR 4.88 to 7.03) mcg/L. The mean concentration was 6.41 mcg/L (range 4.44 to 10 mcg/L).
Tenofovir alfenamide. Fifty-two pregnant women with hepatitis B were given either tenofovir alfenamide (n = 26) or tenofovir disoproxil fumarate (n = 26) from 28 weeks of pregnancy to delivery to prevent mother-to-child transmission. Dosages were not stated. Milk samples obtained 6 hours after delivery from the women taking tenofovir alfenamide contained no detectable (<0.5 mcg/L) tenofovir. Milk samples obtained 6 hours after delivery from the women taking tenofovir disoproxil fumarate contained a median of 12.83 (IQR 7.46–29.46) mcg/L of tenofovir.
Thirty-six lactating women with hepatitis B were given tenofovir alfenamide 25 mg once a day with food and another 36 were given 300 mg of tenofovir disoproxil fumarate once a day. Breast milk samples from both groups were collected at 48 hours postpartum, but the time with respect to doses was not reported. Tenofovir measured by mass spectrometry was undetectable (lower limit of assay not specified) in breastmilk in all of the women given tenofovir alfenamide, while only 4 of the women who received tenofovir disoproxil fumarate had undetectable tenofovir levels. The average milk tenofovir levels in the remaining 32 mothers was 19.2 mcg/L.
Women with hepatitis B received either tenofovir alfenamide 25 mg (n = 12) or tenofovir disoproxil fumarate 300 mg (n = 4) daily from 24 to 28 weeks of gestation until the 4th week postpartum. Milk samples were collected before the dose and 1, 2, 4, 6, 8 hours after the dose on the 3rd day postpartum. Trough and 1-hour post-dose milk samples were also collected on days 15 and 30 postpartum in mothers who received tenofovir alfenamide and on the 7th day postpartum in mothers receiving tenofovir disoproxil fumarate. Mothers who received tenofovir alfenamide had an average peak milk concentration of 101 mcg/L at a median peak time of 4 hours after the dose. Mothers who received tenofovir disoproxil fumarate had a lower average peak milk concentration of 22 mcg/L at a median peak time of 4 hours after the dose. Trough and 1-hour milk tenofovir levels decreased by about 45% at 15 and 30 days postpartum in the tenofovir alfenamide group and by more than half in the tenofovir disoproxil fumarate group at 7 days postpartum. Using the highest milk level on day 3 postpartum, infants would receive a maximum of 15 mcg/kg daily; the average level would be considerably lower.
Ten women with chronic hepatitis B took oral tenofovir alafenamide 25 mg daily. The median peak breastmilk level of tenofovir alafenamide was 2.27 mcg/L (range 0.9 to 11.6 mcg/L) at a median of 0.5 hours after a dose. The median peak breastmilk level of tenofovir was 49.2 mcg/L (range 19 to 80 mcg/L) at a median of 4.25 hours after a dose. The median breastmilk concentration of tenofovir alafenamide was 0.6 mcg/L (IQR, 0.2 to 1.4 mcg/L). The median tenofovir concentration in milk was 31 mcg/L (IQR, 19 to 44 mcg/L) in breastmilk. The half-lives of tenofovir alafenamide and tenofovir in milk were 0.81 and 26.4 hours, respectively.[19,20]
Tenofovir gel. Seventeen women received 40 mg vaginal doses of 1% tenofovir gel daily for 6 days, with the first and last doses applied in clinic under observation. Two women reported using four doses at home, eleven women reported five doses, and two reported six doses. Breastmilk samples were collected before and 2, 4, and 6 hours after the first and last doses. Only 25% of milk samples contained detectable (>1 mcg/L) tenofovir post-dose on day 0, 12.5% at pre-dose on day 6, and 37.5% post-dose on day 6. Breastmilk tenofovir concentrations ranged from 0 to 0.75 mcg/L on day 0 and from 0 to 1.6 mcg/L on day 6.
Infant Levels. Tenofovir disoproxil fumarate. Five infants were exclusively breastfed by 4 mothers who took tenofovir 245 mg (presumably 300 mg of tenofovir disoproxil fumarate) daily. At an average of 1.8 months of age, infant serum tenofovir concentrations were measured. Tenofovir was undetectable (<0.005 mg/L) in the serum of 4 of the infants, and 0.0055 mg/L in the serum of one infant.
In a study of women and their infants receiving antiretroviral therapy for HIV infection, mothers who received a tenofovir disoproxil fumarate-containing regimen were compared to those who did not. The risk of infant death was reduced by 57% among infants who were breastfed and exposed to tenofovir compared to those who were not breasted. No alterations in growth and development were seen among breastfed infants in 2 years of follow-up.
Blood samples were taken from 25 breastfed infants of mothers who were receiving option B+ regimen for prevention of mother-to-child transmission of HIV consisting of tenofovir disoproxil fumarate, lamivudine and efavirenz between 6 and 8 pm daily. The tenofovir dose was not stated, but was presumably 300 mg daily. The median morning infant plasma concentration of tenofovir at 6 months of age was 24 mcg/L (IQR 0 to 51.6 mcg/L). The median morning infant plasma concentration of tenofovir at 12 months of age was 0 mcg/L.
Fifty HIV-negative women who were nursing their infants were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days. A single infant blood sample was obtained after the mother’s 7th dose. Of 49 infant blood samples collected, 46 had an undetectable (<0.31 mcg/L) concentration of tenofovir. The 3 with detectable levels contained 0.9, 0.9 and 17.4 mcg/L of tenofovir.
Tenofovir disoproxil fumarate 300 mg daily was given to 6 HIV-positive nursing mothers. None of the breastfed infants had detectable tenofovir serum levels.
Forty-eight Nigerian and Ugandan women took 300 mg of tenofovir disoproxil fumarate once daily either in the morning or evening as part of a combination therapy for HIV. Their exclusively breastfed infants were fed on demand and had blood samples taken at 2 and 8 hours after the dose. Dried blood spots were analyzed and no infants had a measurable (>4.2 mcg/L) tenofovir blood concentration.
Eleven mothers with chronic hepatitis B who had been taking tenofovir disoproxil fumarate 245 mg daily for at least one month were breastfeeding their infants, 7 exclusively. Infant blood samples were obtained at a median of 12 hours (IQR 10 to 17 hours) after a dose. Infants had a median age of 3 month (IQR 2 to 6 months). All infants had undetectable (<4 mcg/L) tenofovir in their plasma.
Tenofovir gel. Seventeen women received 40 mg vaginal doses of 1% tenofovir gel daily for 6 days, with the first and last doses applied in clinic under observation. Two women reported four doses at home, eleven women reported inserting five doses, and two reported six doses. Infant blood was collected 6 hours after the maternal dose, which ranged from 1 to 4 hours after breastfeeding. Six infants (37.5%) had detectable tenofovir levels after the maternal dose on day 0, and 12 (75%) of infants post-dose on day 6. In infants with detectable tenofovir serum concentrations, day 6 levels were higher (median 2.4 mcg/L) than on day 0 concentrations (median 0). No difference was seen in the anti-HIV activity of breastmilk between day 0 and day 6.
Effects in Breastfed Infants
Two newborn infants whose mothers were treated with tenofovir 245 mg (presumably 300 mg of tenofovir disoproxil fumarate) daily were exclusively breastfed for 3 months. At 4 months of age, neither showed any adverse outcomes on standard developmental parameters.
Five women with hepatitis B infection were treated with tenofovir disoproxil fumarate 300 mg daily beginning in the third trimester of pregnancy and continuing postpartum. Although instructed not to breastfeed, 5 mothers breastfed (extent not stated) their newborn infants. No short-term adverse reactions were seen and the infants’ HBsAg was negative between 28 and 36 weeks of age.
Fourteen mothers were treated with tenofovir disoproxil fumarate (dosage unspecified) during pregnancy (12 beginning in the first trimester) for hepatitis B. Three of the mothers breastfed while taking tenofovir. No adverse outcomes were noted in their breastfed infants up to 1 year of age.
In a study of 50 infants breastfed by HIV-negative women who were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days, 2 infants reportedly had diarrhea lasting 2 to 3 days. No other side effects were reported.
A study of 136 breastfed infants of mothers who took tenofovir disoproxil fumarate, efavirenz and lamivudine during pregnancy and postpartum (Option B+) in Malawi measured bone markers at 1, 6 and 12 months of age. Markers included bone-specific alkaline phosphatase and C-terminal telopeptide of type I collagen. Although tenofovir is known to affect bone density and bone mineral density in adults, no effects were seen on infants’ bone markers in the study.
In a long-term study of tenofovir disoproxil fumarate for chronic hepatitis B, 3 women reportedly breastfed their infants (extent not stated). None of the infants had any adverse effects up to 1 year of age.
A prospective cohort study compared the growth and development of infants of HIV-negative mothers and infants of HIV-positive mothers taking tenofovir disoproxil fumarate and efavirenz as part of Option B+ HIV treatment. Infants were followed up to 12 months of age. No differences in the groups was found in any growth parameters.
A study of pregnant women with hepatitis B infection in China enrolled 143 women. Tenofovir disoproxil fumarate 300 mg daily was given starting at 22 to 33 weeks of pregnancy and continued postpartum. Thirty-one mothers breastfed (extent not stated) their infants who received standard hepatitis B prophylaxis. At 28 weeks postpartum, infant physical and neurologic development was within national standards and none had developed hepatitis B infection. Mild side effects of cough and fever were reported in >5% of infants. Less frequent reactions included skin rash, diarrhea, vomiting, jaundice and pneumonia. All adverse effects were judged not to be related to the drug by the authors.
In a study of 17 nursing mothers who receive 40 mg of 1% vaginal tenofovir gel daily for 6 days, 4 of 17 infants had one or more adverse effects. There were a total of 8 adverse reactions. Seven were mild, and one had diarrhea that was thought to be related to tenofovir exposure.
A study in Malawi compared the infants of HIV+ mothers taking tenofovir disoproxil fumarate and efavirenz (n = 260) to infants of mothers who were HIV negative (n = 125). Infants were followed for growth and development for up to 18 months at which time there were 169 mother-infant pairs in the treatment group and 54 in the HIV-negative group. No difference was found in the growth and development of the breastfed infants of treated women compared to the infants of untreated mothers.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
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