'Option B+' women are at increased risk of loss to follow-up after starting HIV treatment

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Women who begin HIV treatment during pregnancy, or while breastfeeding, prior to the CD4 cell threshold previously recommended for starting treatment (350 cells), were significantly more likely to be lost to follow-up than women who started treatment at the general treatment threshold, Malawian researchers reported last week at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Kuala Lumpur.

Initiating treatment during pregnancy or while breastfeeding when a woman has a high CD4 count, above 350 cells/mm3, is referred to as Option B+ in World Health Organization and national guidelines.

Option B+ was first conceived and implemented in Malawi where the national ART programme had already been functioning well using a public health approach which did not depend heavily on CD4 testing to determine who should initiate treatment. Malawi envisioned that Option B+ would be easier to implement due to its simple 'one size fits all' approach which would enable women to access antiretroviral treatment in settings with poor access to CD4 testing.

Glossary

referral

A healthcare professional’s recommendation that a person sees another medical specialist or service.

loss to follow up

In a research study, participants who drop out before the end of the study. In routine clinical care, patients who do not attend medical appointments and who cannot be contacted.

antenatal

The period of time from conception up to birth.

p-value

The result of a statistical test which tells us whether the results of a study are likely to be due to chance and would not be confirmed if the study was repeated. All p-values are between 0 and 1; the most reliable studies have p-values very close to 0. A p-value of 0.001 means that there is a 1 in 1000 probability that the results are due to chance and do not reflect a real difference. A p-value of 0.05 means there is a 1 in 20 probability that the results are due to chance. When a p-value is 0.05 or below, the result is considered to be ‘statistically significant’. Confidence intervals give similar information to p-values but are easier to interpret. 

renal

Relating to the kidneys.

The analysis presented at the conference looked at the outcomes of all women in Malawi who started treatment in the fourth quarter of 2011 and the first quarter of 2012. A total of 21,939 patient records from 540 sites were included.

In total, 17% of all Option B+ patients were lost to follow-up six months after ARV initiation. Option B+ patients who initiated ARVs during pregnancy were five times more likely to not return to the clinics after their initial visit than patients who started with a low CD4 cell count and/or in WHO clinical stage 3 or 4 (OR 5.2, 95% CI: 4.4-6.2).

Option B+ patients who started treatment while breastfeeding, were twice as likely to miss their first follow-up visit (OR 2.3, 95% CI: 1.8-2.8).

Pregnant Option B+ patients who initiated ARVs on the day they were diagnosed as HIV-infected were less likely to return to clinics than pregnant Option B+ patients who started subsequently (OR 1.7, 95% CI: 1.4-2.2).

Altogether, 37% of the sites performed well, with fewer than 10% of all patients lost to follow-up six months after ARV initiation. However, 33% of the sites had a loss-to-follow-up rate of more than 20%.

Loss to follow-up was somewhat higher at sites operated by the Ministry of Health, compared to sites managed by faith-based organisations (OR 1.19, 95% CI: 0.94-1.5, p=0.04). Patients receiving ARVs at central hospitals were 2.7 times more likely to be lost to follow-up than those treated at health centers (OR2.7, 95% CI: 0.92-7.94, p=0.047).

Option B+ in Uganda

A study of women starting treatment according toOption B+ guidelines in the antenatal clinic and labour ward at Mulago National Referral Hospital in Kampala, Uganda, found that women who enrolled on Option B + in the antenatal clinic were more likely to return for care than those who enrolled in labour wards.

One hundred and ninety women tested positive and 92% were started on antiretroviral treatment in the antenatal clinic between 17 October  and 31 December 2012. A total of 82 % (155 of 190) returned to receive their CD4 results; 162 women were started on antiretroviral treatment after labour began. Only 20 (12%) women returned to receive their CD4 results.

Mulago National Referral Hospital rolled out Option B+ in October 2012. Newly diagnosed HIV-positive women in ANC were initiated on ARVs on the same day and blood was drawn to assess the CD4 cell count and to determine baseline renal and liver function. Women were given an appointment two weeks later to receive their results. Those diagnosed during labour were given ARVs and asked to return after two weeks for CD4 count tests and blood chemistry. At this visit, they were given another two-week appointment to receive results.

The analysis is limited as the study is of a referral hospital and women started on treatment in labour wards could have shifted their care to closer and more convenient ARV centres.

“There is a critical need to determine the dynamics that affect follow-up among women, more especially among women initiated on ART during labour or delivery,“ said Dr Emily Namara-Lugolobi, one of the authors of the study.

References

Tenthani LN Retention of HIV+ pregnant and breastfeeding women on universal antiretroviral therapy (Option B+) in Malawi. 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Kuala Lumpur, abstract WELBD01, 2013. View the abstract on the IAS conference website.

Namara Lugolobi E Retention in care among women initiated on Option B plus in the Antenatal Clinic (ANC) and labour ward at Mulago National Referral Hospital, Kampala, Uganda. 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Kuala Lumpur, abstract TUAC0102, 2013. View the abstract on the IAS conference website.