Efavirenz and pregnancy
Draft UK guidelines on the treatment of HIV in pregnancy no longer recommend that efavirenz (Sustiva, also part of the combination pill Atripla) should be avoided by pregnant women and women hoping to become pregnant.
Previous guidelines had stated that the drug should be avoided during pregnancy. Therapy with the drug during the first three months (trimester) of pregnancy had been linked to a theoretical risk of rare birth abnormalities.
However, UK doctors conducted a rigorous review of the evidence and concluded: “There are insufficient data to support the former position [of avoiding the drug] and [we] furthermore recommend that efavirenz can be both continued and commenced during pregnancy.”
This means women who are hoping to become pregnant can continue to take efavirenz, as can women who become pregnant.
World Health Organization (WHO) guidelines recommend the use of efavirenz during pregnancy. However, US guidance issued in 2010 says that the drug should be avoided during the first trimester.
Other key recommendations in the draft UK guidelines include:
HIV treatment if a mother needs it for her own health
- Start treatment according to adult guidelines.
- There is more experience of using a 3TC/AZT (available in the combination pill Combivir) backbone in pregnancy, but FTC/tenofovir (available as Truvada) or 3TC/tenofovir are acceptable alternatives.
- Nevirapine (Viramune) is the preferred third drug for women with a CD4 cell count below 250.
- Monitoring of drug levels in the third trimester should be considered for women taking a combination that includes tenofovir and atazanavir (Reyataz).
If the mother does not need HIV treatment for her own health
- She should start treatment at between 14 and 24 weeks of pregnancy. The exact starting time will depend on her viral load.
- A combination based on a ritonavir-boosted protease inhibitor is preferred.
- 3TC, AZT and abacavir (available as the combination pill Trizivir) can be used if viral load is below 100,000 copies/ml.
- AZT monotherapy is acceptable if viral load is below 10,000 copies/ml, CD4 cell count is above 350 and the mother is planning a caesarean delivery.
- If a woman presents late (after week 28) than potent HIV treatment should be started immediately. If viral load is above 100,000 copies/ml or unknown then a three or four drug combination including raltegravir (Isentress) is recommended.
Mode of delivery
- Vaginal delivery is recommended for women who have a viral load below 50 copies/ml at week 36 of pregnancy.
- A planned caesarean section is recommended for women taking AZT monotherapy and for those with a viral load above 400 copies/ml.
Infant prophylaxis
- AZT monotherapy is recommended for all infants if maternal viral load is below 50 copies/ml at week 36.
- Infants under 72 hours old, whose mothers had undiagnosed HIV infection, should start potent triple-drug antiretroviral therapy immediately.
- Potent triple-drug HIV therapy is recommended in all circumstances when maternal viral load is above 50 copies/ml at week 36 of pregnancy.
- Infant prophylaxis should be continued for four weeks.
- Exclusive formula feeding is recommended in all circumstances.
- Tests looking for HIV’s genetic material should be performed within 48 hours of birth and prior to hospital discharge. These tests should be repeated when the infant is six and twelve weeks old, or if there has been a risk of exposure to HIV (e.g. via breast feeding).
- An HIV antibody test should be performed when the infant is 18 months of age.
The draft guidelines can be read on the British HIV Association website here. They are open for comments until Friday (24 February).
Many HIV-positive women in the US have experienced trauma
Women account for 27% of new HIV diagnoses in the US, and the majority of HIV-infected women come from disadvantaged communities. Trauma is a recognised factor in poorer HIV treatment outcomes.
Investigators looked at the results of 29 studies that examined experiences of trauma and post-traumatic stress disorder in women with HIV in the US.
They found that about a third of women had post-traumatic stress disorder. Over half (55%) had experienced intimate partner violence. Just over a third of women reported adult sexual abuse and 54% reported being physically abused as an adult.
The prevalence of trauma and abuse reported by HIV-positive women was much higher than that observed in the general US population.
The researchers recommend that detecting trauma and the provision of appropriate support and treatment should be a priority for HIV care.
“Screening and referrals for recent and past trauma and post-traumatic stress disorder should be considered a core component of HIV treatment in this population, along with medication adherence, CD4 cell counts and viral loads.”
Nevirapine rash
Treatment with nevirapine can cause a rash. The risk of rash and liver toxicities is greatest during the first few weeks of treatment with the drug.
In some circumstances the rash can be very serious, even life-threatening. Because of this, women with a CD4 cell count above 250 should not start treatment with nevirapine, nor should men with a CD4 cell count above 400.
Now a study involving HIV-positive women has shown that the risk is linked to slow clearance of the drug from the body.
The study’s authors stress the importance of monitoring blood levels of nevirapine as a way of avoiding or managing the risk of rash.