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Page 4 of 8  Guideline


              BOX 1: Use of dolutegravir in women of childbearing potential.  If suppressed, the VL should be repeated at delivery. For
               Care should be provided in ways that respect women’s autonomy in decision-  WLWH and who are already on  ART, the VL should be
               making about their health, and services must provide information and options to
               enable women to make informed choices.  To this end, all women considering   measured at the first antenatal care visit, as per previous
                                      22
               the use of dolutegravir (DTG) should be informed of the following:
                                                                    guidelines. If suppressed, the VL is repeated at delivery,
               •   Dolutegravir is an effective and well tolerated antiretroviral drug that is safe to
                use during pregnancy after closure of the foetal neural tube (from the seventh   unless subsequent VL non-suppression is suspected. Accurate
                week of pregnancy onwards). Current evidence indicates that DTG is safe to   recording, of antenatal maternal VL testing data in the
                use during lactation. 23,24
                                                                    maternity case record, is crucial to ensure communication and
               •   Using DTG at the time of conception carries an approximately 0.3% risk of a
                neural tube defect (NTD) in the infant, according to currently available   continuity of care between antenatal and delivery services.
                evidence. This compares to a 0.1% background risk of having a child with a
                NTD if an alternative regimen is used. 20
               •   It is advised that any non-pregnant woman using DTG should use reliable and   Women initiating ART at any time after 28 weeks gestation
                effective contraception (hormonal methods or an intra-uterine contraceptive   will have a VL measurement done at delivery and repeated
                device). On subsequent changes in a woman’s fertility intentions, coupled with
                concerns about the risk of NTDs, a switch from TLD to TEE may be offered,   three months after delivery. If the mother-infant pair is
                provided a suppressed HIV viral load in the last six months has been
                documented.                                         receiving integrated care, this VL should be aligned to the
               •   Women already on antiretroviral therapy wanting to switch to a DTG-  10-week well-child immunisation visit.
                containing regimen should be aware of the following in addition to the points
                listed above:
                       ß  New side effects may be experienced when switching from an   Viral load monitoring at delivery and six months
                      EFV-containing regimen to a DTG-containing regimen (insomnia,   after delivery
                      headache or gastro-intestinal disturbances). These are uncommon,
                      usually mild and self-limiting, and should be reported to the health   Previous implementation of VL monitoring in the PMTCT
                      care provider immediately without stopping treatment.
                                                                    programme has been suboptimal. Thus, the VL monitoring
                       ß  Efavirenz-based regimens should be taken at night, whilst the
                      DTG-based regimens can be taken either in the morning or at night.   schedule, that had been linked to the ART history and timing
                      If insomnia is experienced, morning dosing might be preferable.
                                                                    of  ANC booking, has been changed to fixed time points
              DTG, dolutegravir; NTD, neural tube defects; EFV, efavirenz; TLD, tenofovir,
              lamivudine and dolutegravir; TEE, tenofovir, emtricitabine and efavirenz.  linked to the pregnancy itself. A VL at delivery has, therefore,
                                                                    been introduced for all WLWH. Much debate has ensued
              Antiretroviral therapy is to be continued the following day   with regard to the best timing of a VL around the time of
              after  understanding  the  woman’s  fertility  intentions  and   delivery. Whilst results of a VL done at 36 weeks’ gestation
              appropriate counselling on the risk of DTG-associated NTDs   would be available by the time of delivery, a significant
              for her subsequent pregnancies. The recommended regimen   proportion of women, including those with premature
              in the period after birth is TLD. Concurrent use of effective   labour, those with uncertain gestational age, and un-booked
              contraception is recommended for all women at discharge   deliveries,  would  not  receive  a VL  at  36 weeks’  gestation.
              from labour wards.                                    Additionally, antenatal care usually occurs at a different
                                                                    facility from delivery, and antenatal VL results may not be
              Maternal human immunodeficiency virus viral           available at the delivery site.
              load monitoring
              Potent ART regimens are most effective when coupled with   A VL done at the actual time of delivery has the following
              HIV VL monitoring to confirm good adherence and viral   advantages:
              suppression or to  allow the timely  detection  of  factors that   •  High in-facility birth rates, and previous rapid uptake
              may negatively affect viral suppression (e.g. suboptimal   and high coverage of infant birth PCR testing within
              treatment adherence, drug interactions, intercurrent infections,   labour wards, infer the possibility of near-universal
              etc.). Importantly, VL monitoring can only be effective if   coverage of the delivery VL.
              coupled with a response to the test results, and women with   •  Uniformly performed VLs at time-point of delivery will
              detectable VL results (VL > 50 c/mL) must be followed up for   enable the health system to monitor and better enforce
              urgent intervention, directed to ensure immediate viral   the coverage of maternal VL testing.
              suppression.  Accurate national surveillance of maternal VL   •  Viral  load  testing  at  delivery  allows  for  placing  of  the
              suppression will require a means to distinguish between VLs   reference to the maternal laboratory testing into the
              done during antenatal care, at delivery, and after birth. Within   infant’s Road-to-Health Booklet to provide a potential
              the public sector this will be achieved through the use of   link for PMTCT interventions, promoting integrated care
              electronic gatekeeping codes submitted on National Health   for the mother-infant pair and ensuring consideration of
              Laboratory Service (NHLS) requisition forms (code       maternal laboratory results during infant health care
              C#DELIVERY applied to VLs at delivery, and  C#PMTCT     provision.
              applied to VLs during the antenatal and postpartum periods).   •  It provides a means  of epidemiological  surveillance  of
              Of great importance, colleagues in the private sector may wish   vertical transmission risk at delivery.
              to discuss with their laboratory service the value or feasibility
              of implementing such a coding system in their practice.
                                                                    Given that more than half of vertical transmissions now
                                                                    occur after delivery, 8,27  linked to postpartum challenges to
              Viral load monitoring during the antenatal            adherence and retention in care, 9,10,11,12  a maternal VL should
              period                                                be done at six months after delivery for all WLWH, aligned
              Women  initiating  or  re-initiating ART  in  pregnancy  should   to the six-month well-child immunisation visit, regardless of
              have their first VL measured three months after starting ART.   breastfeeding status. As the maternal VL impacts directly on


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