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HIV/AIDS Treatment and Care : Clinical protocols for the European ...

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248<br />

<strong>HIV</strong>/<strong>AIDS</strong> TREATMENT AND CARE CLINICAL PROTOCOLS FOR THE WHO EUROPEAN REGION<br />

3.4. Second-line HAART regimens<br />

For second-line HAART, WHO recommends selecting three different drugs containing at least one<br />

new pharmacological class.<br />

• The best options are regimens with a boosted protease inhibitor (PI) as <strong>the</strong> key drug, toge<strong>the</strong>r<br />

with two nucleosides if a classical approach of 2 NRTIs + 1 NNRTI was <strong>the</strong> first-line treatment.<br />

• In case of a simplified first choice with 3 NRTIs, <strong>the</strong> second-line should use a boosted PI + 1<br />

NNRTI <strong>and</strong>/or 1 NRTI.<br />

Among second-line NRTIs, those with better resistant profiles, such as ddI, ABC <strong>and</strong> TDF, should<br />

be given preference.<br />

• The combination d4T+ddI has to be avoided due to <strong>the</strong> risk of mitochondrial toxity, leading to<br />

hepatic steatosis <strong>and</strong> potentially enhancing fibrosis (56).<br />

• TDF/ddi is also contraindicated due to negative pharmacological interactions.<br />

Table 8. treatment regimens <strong>for</strong> second-line HaaRt in HiV/HCV-coinfected patients<br />

ARV drug classes HAART regimens<br />

ABC + TDF LPV/r<br />

or<br />

Preferred second line 2 NRTIs + 1 boosted PI<br />

or + SQV/r<br />

or<br />

ABC + ddIa ATZ/rb Alternative second line<br />

1 NNRTI +/- 1 NRTI + 1 boosted PI<br />

ABC Ó Ï LPV/r<br />

EFV Ë SQV/r<br />

TDF Ï Ó ATZ/r b<br />

or<br />

LPV/r + EFV<br />

or<br />

LPV/r + SQV<br />

a A ddI dose in combination with TDF should be adjusted to less than 4.1 mg/kg per day so as not to compromise immune<br />

recovery. It is contraindicated in patients with cirrhosis <strong>and</strong> under RBV treatment, <strong>and</strong> should be used with caution in<br />

patients with less severe liver disease.<br />

b Unboosted ATZ or NFV can be used in absence of a cold chain.<br />

4. Coinfected patients requiring both HCV <strong>and</strong> <strong>HIV</strong>/<strong>AIDS</strong> treatment<br />

Coinfected patients requiring both HCV <strong>and</strong> <strong>HIV</strong>/<strong>AIDS</strong> treatment meet <strong>the</strong> following criteria:<br />

• CD4 count ≤350 cells/mm 3 in symptomatic patients or patients with viral load >100 000 copies/ml,<br />

or CD4 count ≤200 cells/mm 3 irrespective of symptoms; <strong>and</strong><br />

• acute or chronic hepatitis C. 12<br />

4.1. Strategy <strong>for</strong> initiation of treatment<br />

See Table 9 below.<br />

• If a coinfected patient has severe immunodeficiency (CD4 count 200 cells/mm 3 ) <strong>for</strong> a few months be<strong>for</strong>e starting HCV<br />

treatment. HAART should be continued during HCV treatment but ddI, ZDV or d4T should be<br />

changed <strong>for</strong> o<strong>the</strong>r drugs (ABC, TDF, etc.) be<strong>for</strong>e initiating RBV.<br />

12 For patients with evidence of advanced liver fibrosis, HCV treatment should be a priority.<br />

or<br />

double PI

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